Download Directory Of Services 2013

Directory of Services
2013
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A comprehensive
guide to utilizing
and interpreting
diagnostic tests to
improve patient
health
Pathology Insights
2013
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Quest Diagnostics Specimen collection tubes
When using a winged blood collection set for venipuncture and a coagulation (citrate) tube is the first specimen to be drawn, a discard tube should be
drawn first. The discard tube must be used to fill the blood collection set tubing’s “dead space” with blood but the discard tube does not need to be completely filled. This important step will ensure maintenance of the proper blood-to-additive ratio of the blood specimen. The discard tube should be a
nonadditive or coagulation tube.
Stopper/Label color
Laboratory use
The stopper color alone does not indicate
tube type - also refer to the tube label.
Additive/Inversions at
Collection
8 gentle inversions
unless otherwise noted
GOLD
Serum Separator Tube (SST) for serum determinations in chemistry and
serology. Contains separator gel and should not be used for toxicology or
drug testing. Inversions ensure mixing of clot activator with blood. Blood
clotting time 30 minutes.
• Clot activator and gel for
serum separations
RED
For serum determinations in chemistry and serology, and for toxicology
and drug testing. Glass serum tubes are recommended for blood banking.
Plastic tubes contain clot activator and are not recommended for blood
banking. Inversions ensure mixing of clot activator with blood and clotting
within
60 minutes.
• Clot activator
ROYAL BLUE
For trace-element, toxicology and nutritional-chemistry determinations.
Special stopper formulation provides low levels of trace elements.
• Sodium heparin
• Na2 EDTA
• None (Serum tube)
GREEN
For plasma determinations in chemistry. Tube inversions prevent clotting.
• Sodium heparin
• Lithium heparin
GRAY and
White Label
For glucose determinations. Oxalate and EDTA anticoagulants will give
plasma samples. Sodium fluoride is the antiglycolytic agent. Inversions
ensure proper mixing of additive and blood.
• Potassium oxalate/sodium fluoride
• Sodium fluoride/Na2 EDTA
TAN
For lead determinations. This tube is certified to contain less than
0.01 ug/mL (ppm) lead. Inversions prevent clotting.
• Sodium heparin (Glass)
• K2 EDTA (Plastic)
YELLOW and White
Label with Yellow
horizontal stripe
Glass tube with liquid ACD for use in blood bank studies,
HLA phenotyping, DNA, paternity testing, etc
• Acid Citrate Dextrose ACD):
Solutions A/B additives-Trisodium
citrate 22.0/13.2, citrate acid
8.0/4.8 and dextrose 24.5/14.7 (in g/L)
YELLOW (Culture)
and No Paper Label
(Adult tube) or Yellow
Label (Pediatric tube)
Glass tube with liquid SPS anticoagulant for mycobacterial
(tuberculosis) and fungus blood culture.
• Sodium Polyanethol Sulfonate (SPS)
0.35% in 0.85% Sodium Chloride
LAVENDER
K2 EDTA for whole blood hematology determinations and
immunohematology testing (ABO grouping, Rh typing,
antibody screening). Inversions prevent clotting.
• Spray-dried K2 EDTA
LIGHT BLUE
For coagulation determinations. NOTE: Certain tests may require
chilled specimens. Follow recommended procedures for collections
and transport. Inversions prevent clotting.
• 0.105 M sodium citrate (=3.2%)
4 Inversions
GRAY and
Yellow Label
For culture and sensitivity (C&S) urine testing. Minimum urine volume is
5 mL. For lower volumes, submit refrigerated urine in a sterile container
without preservatives.
• Boric acid, sodium formate
Shake vigorously
YELLOW PLASTIC
and Yellow Label
For urinalysis testing. Inversions ensure preservative is properly mixed.
Note the fill lines. Do not under fill (<2 mL) or overfill (>10 mL).
• Preservative
Urine specimens
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Order of Draw1
Tube type
Additive
Inversions
Determination
Sterile samples (eg: Blood cultures)
Light blue
• 0.105M/0.109m
Sodium citrate
(=3.2%)
3-4
For coagulation determinations
Gold
• Clot activator and
gel for serum
separation
5
For serum determinations
in chemistry
Red
• Clot activator PLUS
• None (Glass)
5
0
For serum determinations
in chemistry, serology and
blood banking applications
Light green
• Lithium heparin and
gel for plasma
separation (PST)
8
For plasma determinations
in chemistry
Green
• Lithium heparin
8
For plasma determinations
in chemistry
Lavender
• Spray-dried K2 EDTA
8
For whole blood hematology
determinations & blood banking
applications
Gray
• Potassium oxalate/
sodium fluoride
• Sodium fluoride/K2
EDTA
8
For glucose determinations
*NOTE : Small volume partial draw tubes fill more slowly than full - draw tubes to a lower vaccum.
1. NCCLS H3-A 5th Edition 2003.
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Quest Diagnostics proper phlebotomy techniques
Collect
Stopper
Additive
YELLOW
Sequence
First
SPS
(Culture)
LIGHT BLUE
Citrate*
YELLOW
Citrate ACD
GOLD
Gel, serum
RED
No gel, serum
GREEN
Heparin
LAVENDER
EDTA
GRAY
Sodium flouride
** When using a winged blood collection set for venipuncture and a coagulation (Citrate) tube is the first specimen to be drawn, a discard tube should be drawn first. The discard tube must be used to fill the blood collection set tubing’s “dead space” with blood but the discard tube does not need to be completely filled. This important step will ensure mainte
nance of the proper blood-to-additive ratio of the blood specimen. The discard tube should be a nonadditive or coagulation tube.
(Glucose)
TUBES WITH OTHER ADDITIVES
Light blue tubes
All plastic tubes other than
Light blue, Gold & Red tube
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5
Clot
Clot
30-60 minutes
30-60 minutes
Patient ID
Clot
30-60 minutes
Patient ID
Do not use
gel tubes for
toxicology or
drug testing
Patient ID
Separate
Gold / Red tubes
SERUM
Mix Gently
Last
See Blood, Serum or Plasma in the Specimen Collection and Handling section of this Directory
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Dear customer,
Thank you for choosing Quest Diagnostics. Quest Diagnostics is the world’s leading provider of pathology testing
and services. Our state-of-the-art laboratory in Gurgaon and affiliate labs in the USA offers the latest testing for
Patients, Hospitals, Physicians, Companies & Pharmaceutical companies.
Our new Directory introduces a comprehensive menu of services and resources to enhance the efficiency of your
practice and deliver laboratory results of the highest quality to your patients.
Looking forward to working with you
Sincerely,
Quest Diagnostics India Team
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An Introduction to Quest Diagnostics
Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services. Across the globe each day more than half a million people entrust us with their diagnostic testing. Each year we perform testing on more than 150 million patients. We offer the broadest test menu in the industry with more than 3000
tests including those covering Obstetrics/Gynaecology, Urology, Gastroenterology, Oncology, Endocrinology, Cardiovascular and Infectious Disease testing. As a leading innovator in the clinical laboratory industry, Quest Diagnostics has introduced over a 100 new tests and technologies, that help physicians and their patients make better healthcare decisions.
In addition to diagnostic testing services to healthcare providers we offer a unique value to Pharmaceutical companies through Central Laboratory and related services for their Clinical Trials.
With over 42,000 dedicated employees, the company’s vision is to “improve the health of patients through unsurpassed diagnostic insights and innovation”.
The guiding principle for each our employee is to ‘Put Patients First’. It defines everything we do - our services, our values, our innovations.
What makes us different?
Innovation: Through our world renowned research lab – Quest Diagnostics Nichols Institute, we introduce innovative assays every year and have often been first in providing access to advances in laboratory testing. We lead the way in:
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Genetic Testing by pioneering Spectral Karyotyping
Oncologic and haematologic testing with Leumeta™ & CellSearch™
Cardiovascular Disease with LDL subparticles and CardioCRP™ testing
Endocrine System Disorders with many of the thyroid tests that are performed in other laboratories have been pioneered at our Quest Diagnostics Nichols Institute
Infectious Disease with HEPTIMAX™
Gynecology with the Penta Screen™ test for Maternal Serum screening
Esoteric testing: Quest Diagnostics has established leadership in esoteric testing, providing you the access to the most advanced diagnostic testing capabilities through highly specialised laboratories that serve as centers of excellence for:
• Coagulation and Oncology
• Infectious Disease testing and development of new tests
• Dermatopathology and Anatomic Pathology
Quality: The foundation of our quality efforts is the rigorous statistical methodology of Six Sigma. Quest Diagnostics has pioneered the application of Six Sigma principles in clinical laboratory diagnostic testing – maximising quality and efficiency. Our quality assurance efforts focus on being:
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Customer-Driven
Process-Oriented
Performing Error-Free Work
Continuously improving
Scientific Expertise: Our scientific and academic staff has more than 900 MDs and PhDs you can count on for expert scientific consultation regarding test selection and interpretation of test results.
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Delivering global quality standards in India
Quest Diagnostics has established a presence in India with a 65,000 square-foot state of the art clinical laboratory
in Gurgaon, near Delhi. We offer unmatched esoteric and routine testing capabilities through our network of laboratories in India and the US. Our expertise in highly specialised Genetic, Oncology, Anatomic Pathology, Endocrinology, Gynaecology, Cardiovascular and Infectious Diseases testing enables us to offer the most comprehensive and differentiated test menu and services. So now, when it comes to your need for unique and rare testing, we have you covered.
Our company owned and operated Patient Service Centers (PSCs) at convenient locations enable us to not only
ensure a strict quality control on pre-analytical sample handling, but also provide you with greater access to our
services.
In order to provide you with quality consistent with our global quality standards, our laboratory in India follows standardised protocols, processes and procedures and even utilizes the same kits and the same key reagents, as done by all other Quest Diagnostics labs worldwide.
The integrity and reliability of the tests performed at Quest Diagnostics provides you with the confidence you need
in laboratory results to better support and manage your patient’s health.
Services that go beyond diagnostic testing
Our services do not stop at diagnostic testing and test reporting. Our online resources provide you with a host of
informational services for you and your patients.
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Keep abreast with emerging trends in diagnostics. Sign up for our Physicians Update feature available on our website Quest4Health.com
Data on more than 600 medical tests and 1,900 health conditions provide information on prevention, importance of screening and lifestyle on our online Patient Health Library
At Quest Diagnostics we are committed to quality and dedicated to patients. That is how we can help you to help your patients.
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India Test Guide
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Test guide
This Test Guide defines the essential procedures for
the collection and transport of each specimen type.
The information is specific for the analytical methods
used at Quest Diagnostics at the time of publication
of this Test Guide. Additional information is available
in the Test Application and Interpretation section
and at QuestDiagnostics.in.
Where To Find Information In This Test Guide
Test Guide provides brief information about our
services, our facilities and quality programs.
Specimen Collection and Handling provides general
information on procedures necessary to obtain and
submit proper samples and expanded collection
information for selected tests.
Test Requisition Information provides instructions
on the proper completion of a Quest Diagnostics test
requisition.
General Test Listing includes specific specimen type
and sample transport information for individual
tests/profiles organized alphabetically.
Index By Test Name lists page numbers for tests
organized alphabetically.
Index By Test Code lists page numbers for tests
organized by Quest Diagnostics Test Codes.
Your Account Management Team
As a client of Quest Diagnostics, you will have an
individual account representatives who will assist
you in the best use of our laboratory tests and
services.
You are assigned a unique Quest Diagnostics
Account Number, an essential identifier, that must
be written on your test requisitions to ensure
correct reporting, billing and communications.
Client Services
Our Client Services representatives are available on
the telephone to answer your questions about test
menu, test results and problem resolution.
Test Additions After Submission of Specimen
Client Services can arrange for additional testing if
the specimen is stable and the volume sufficient
after initial tests have been completed. We are
required to request written authorization for every
test we perform. Our clients will receive a request
for written confirmation for oral test requests via
hard copy reporting or by telephone. The physician
or authorized individual must sign and return this
written confirmation.
Quality Assurance: An Overview
As part of an extensive set of activities focused on
quality, Quest Diagnostics has a formal Quality
Assurance Program that monitors and evaluates the
quality of the testing process (pre-analytic, analytic,
and post-analytic). Quality test results and interpretation
requires the engagement of all parties – the patient, the
physician, the suppliers of test equipment and reagents,
the information system, the laboratory, and everyone
involved. To assure quality, standards are defined, work is conducted based on the standards, and performance
measured and reported. The laboratory cannot deliver
quality alone. You too are an integral part of this process
that brings quality to every patient. Our goal is to become
the first laboratory in our industry to aspire to virtual
error-free performance by embracing the principles of Six Sigma Quality, a measurable set of interrelated business objectives, based on the Voice of the Customer.
Repeat Determinations
We will repeat a test without charge whenever, in the
physician’s opinion, the result does not correlate with the patient’s clinical profile. Please call the laboratory
as soon as possible after the original result is reported.
When requesting a repeat determination on a new specimen, include the prior laboratory specimen number
and explain the circumstances for the request on the test
requisition accompanying the new specimen. Follow-up
or confirmatory testing is not considered a repeat determination. These specimens will be processed and billed as new requests.
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Reporting
Specimens are processed upon receipt. Reporting
times vary, depending upon the nature of the test,
the analytical time required for the procedure and
the method of reporting. Reports are delivered by
facsimile, e-mail, or by the Postal Service. Critical
priority (potentially imminently life threatening) and
STAT results are communicated by telephone as
soon as they are available and are followed by
written reports.
Confidentiality
Quest Diagnostics is committed to protecting the
confidentiality of individuals’ private laboratory test
results and other personal information in compliance
with all applicable laws and regulations.
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Transport
Blood
Urine
Specimen Collection
and Handling
Bacteria
Fungus cultures
Parasitology
Virus
Serology
Cytology
Hematopathology
Tissue pathology
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Transport
Results are only as meaningful as the quality of the
specimen submitted for analysis. Specimen requirements for each test are included in the General Test
Listing section. Expanded instructions for selected
tests are included in this Specimen Collection and
Handling section. If needed, please contact the laboratory for clarification prior to specimen collection.
It is critical that an adequate specimen volume is
submitted for analysis. The volume requested in this
Guide is sufficient for initial analysis and for any confirmatory tests that might be needed. If initial
repeat or confirmatory tests cannot be performed,
the medical report will indicate that the specimen
quantity submitted was Quantity Not Sufficient
(QNS) for testing.
Health and Safety precautions
Use universal precautions [hand washing, the use
of gloves and other barriers, correct sharps, as well
as, aseptic techniques] when handling specimens
containing blood or other potentially infectious material. Work areas contaminated with blood or
serum must be cleaned and disinfected immediately
with 10% bleach (hypochlorite 0.5% final concentration) or other approved disinfectant. First aid
includes washing cuts and needle sticks with soap
and water; flushing splashes to the nose, mouth, or
skin with copious amounts of water; and irrigating
eyes with clean water, saline, or sterile irrigants.
Specimens should be handled in a safe manner and
according to applicable legal requirements or guidance. In handling human specimens, the goal
is to protect health care workers from exposure to
blood and to other potentially infectious body fluids.
Patient preparation
Many tests require specific patient preparation, i.e.,
fasting, diets and urinary voidings. If you have questions about patient preparation for any test,
please consult this Guide or call Client Services for
further assistance.
Fasting requirements
A fasting specimen is preferred for some of the tests
performed on serum, plasma, or whole blood. Nonfasting specimens often contain fat particles that can
interfere with many analytical procedures. See Common
Causes of Unacceptable Blood Specimens and Inaccurate
Test Results (Turbidity) in the Blood, Urine, and Stool
section.
Fasting is defined as no consumption of food or beverage,
other than water, plain tea and black coffee (no sugar, no
milk or cream), and required medication. For lipids (notably triglycerides and calculated LDL cholesterol)
patient should be fasting 12–14 hours. The patient should
be on a stable diet 2 weeks prior to collection of blood.
For other tests (i.e., fasting glucose) patients should fast
for a minimum of 8 hours.
Use medical judgment concerning medication that
should be taken with a morning meal if a pecimen is collected for a test that is best interpreted when the
patient is fasting. A direct measure of LDL cholesterol is
available that does not require patients to fast if this test
is appropriate for patient risk assessment and disease
management.
Provocation tests
Some tests require the patient to ingest a substance. The most common are the Oral Glucose Tolerance Tests
(OGTT) where the patient drinks a solution containing
glucose, and blood samples are obtained before and at
various times after the drink, to measure the concentration of glucose in plasma or serum. In the standard Oral
Glucose Tolerance Tests, adults ingest 75 g of a glucose
solution.
Children ingest an amount of glucose proportional to
their body weight: 1.75 grams of glucose per kilograms of body weight, up to 75 g of glucose. The maximum is
reached at a weight of 40.6 kg.
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Weight of Patient (kg)
Amount of Glucose (g)
10.9-14.5
14.6-19.0
19.1-23.2
23.3-27.7
27.8-31.8
31.9-36.4
36.5-40.5
>40.5
22.5
30
37.5
45
52.5
60
67.5
75
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Test(s) requested
Date of specimen collection, when appropriate
Source, type of specimen and time of collection,
when appropriate
Clinical information, when appropriate
When ordering tests in a series, e.g., growth-hormone
stimulation and oral glucose tolerance test:
Proper Identification of Specimens
1. Use one test requisition.
2. Label each specimen with the patient’s name, date and time, or site (if applicable).
3. Write the number of specimens on the test
requisition.
4. Submit all specimens within a series together.
Specimen labels
Improperly labeled specimens will be rejected.
Each specimen submitted must have a label. This
label must include the patient’s full name, written
exactly as it appears on the test requisition (e.g.,
Kumar, Sumit), your account number, and date of collection. Be sure that the label is securely attached.
If the label is handwritten, please use a ballpoint pen
with black\blue ink.
Packaging
When submitting a specimen in a container other
than the tube used to draw the sample (e.g., transfer vials), also indicate specimen type on the label,
e.g., serum, plasma, and urine. When submitting
specimens for microbiological testing (e.g., cultures,
bacterial antigen, microscopic examination) the
nature and anatomic source of the sample and the
specific organism(s) to be detected, if any, should be
specified.
Test requisition
Specimens must be accompanied by a paper requisition. The requisition, at a minimum should contain
the following information:
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Adequate patient identification information, e.g., name, address, telephone number
Patient gender
Patient date of birth
Name, address, and contact information of the
physician or hospital ordering the test
The following are the minimum specimen packaging
guidelines that should be followed when submitting
specimens.
1. Ensure that all specimen container caps and lids
are properly tightened to prevent leakage.
2. Properly complete the requisition.
3. Collect the specimen(s) in a proper transport con
tainer.
4. Remove a self-stick label from the bottom of the
pre-printed test requisition and affix this label to
the specimen transport container. Place this label
on the container so it does not cover the hand
written patient name.
5. The specimen transport bag has two pouches.
Place the specimen container(s) in the rear pouch
(printed side) and the test requisition in the front
pouch (unprinted side).
6. Frozen specimens should be transported in plastic screw-cap containers only. Frozen specimens must be placed in a separate specimen bag along with a separate test requisition. Frozen specimens cannot be split for other tests. If more than one test is ordered on a single frozen sample, we will call you to authorize which of the tests ordered you want performed before testing can proceed.
7. Remove the protective strip and seal the speci-
men bag. The protective strip must not obstruct the bar code. This will protect the test requisi-
tion from leakage and help ensure that the patient information can be entered directly into the laboratory computer by scanning of the bar code.
Holding and Securing Specimens
While awaiting pick-up, specimens should be maintained at room temperature (<32°C) or on cold
packs unless otherwise noted under the “Transport
Temperature” or other specimen requirement in this
section or in the General Test Listing section.
Customers are responsible for the security of specimens prior to pickup.
Infectious Substances
For courier transport: bacterial isolates should be
submitted in a screw-cap agar slant using Trypticase
soy agar with or without 5% sheep blood or Chocolate
agar. Fungal specimens should be submitted in a screw-cap agar slant of Sabouraud Dextrose agar. All tubes must be appropriately labeled, tightly capped
and sealed with tape or parafilm. Do not submit bacterial or fungal cultures on petri dishes. (See Transport of Bacterial Isolates in the Bacteria section.) Place each isolate to be transported in a separate Specimen Transport Bag with the absorbent
material. It is important to use a separate bag for each isolate.
Frozen Specimens
Frozen specimens must be transported in insulated
containers surrounded by an ample amount of dry ice to keep the specimen frozen until it reaches the laboratory. Thawed specimens are unsuitable for analysis.
In the event a thawed specimen is received, you will
be asked to resubmit an adequate specimen.
If you would like more information about sending
specimens to Quest Diagnostics, please contact The Client Services Department.
Transporting Specimens to Quest Diagnostics
Needles, Sharps or Medical Waste
Do not send any needles or other sharp or breakable objects. Do not send medical waste as
a diagnostic specimen since it may create a health
hazard. Properly discard used needles or other sharps prior to transport. Please note for tests requiring the submission of syringes, the needle must be removed and the syringe capped before
sending to the laboratory. Ensure that there is no
leakage from or visible contamination outside the
specimen container.
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Blood
Blood, Serum, or Plasma
Phlebotomy
Most blood specimens can be obtained using routine
phlebotomy techniques; however, there are some
exceptions. The use of a tourniquet can cause stress
and is not recommended in some cases. Patients
should be instructed not to clench their fist(s) just
prior to or during the phlebotomy procedure as this
may alter some of the patient’s laboratory results,
such as the concentration of potassium in serum. The patient’s posture, (sitting, standing or supine) or
the time of day of phlebotomy can be important factors for some tests (e.g., therapeutic drug monitoring and hormone tests). If in doubt, please
consult this section and the General Test Listing section of this Guide before scheduling the patient
for phlebotomy. The inside front and back covers of
this Guide display blood collection tube types and
important details of proper phlebotomy technique.
Handle all biologic samples and blood collection
“sharps” (lancets, needles, Luer adapters and blood
collection sets) according to the policies and procedures of your facility. Obtain appropriate medical
attention in the event of any exposure to biologic
samples (for example, through a puncture injury)
since they may transmit viral hepatitis, HIV (AIDS),
or other infectious diseases. Use any built-in used
needle protector, if the blood collection device
provides one. Reshielding/recapping used needles is
prohibited. Discard any blood collection “sharps” in
biohazard containers approved for their disposal.
Whole Blood
The most common test using anticoagulated whole
blood is the Complete Blood Count (CBC) and blood
film morphology, which should be collected using a
lavender top (EDTA) vacuum tube. Other tests might
require anticoagulants such as green-top (heparin)
or light bluetop (sodium citrate) tube. Follow instructions for the individual test.
Collect an adequate volume of blood. Fill the tube to
capacity, since partial filling will result in distortions
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caused by the osmolality of the anticoagulant. Under
filled or overfilled blood collection tubes will not be
accepted for testing. Immediately mix the blood thoroughly with the additives by gently inverting eight
(8) times, or four (4) times when using light blue-top
(sodium citrate) tubes. Incomplete mixing or delay in
mixing after phlebotomy will result in microscopic partial
clotting of the sample, which can cause spuriously low
platelet counts. Maintain the specimen at room temperature (<32°C) or on cold packs before submitting to our
laboratory, unless instructed otherwise by the specimen
requirement information in this Guide or by the laboratory. Never freeze whole blood unless it is specifically
instructed in the specimen requirement instructions.
If you store cold packs in the freezer, be sure to allow
sufficient time for them to warm to refrigerator temperature before placing whole blood specimens near them. To minimize the risk of hemolysis, do not place whole
blood specimens in direct contact with cold packs.
Plasma
Evacuated tubes used to collect plasma specimens
contain anticoagulant (e.g., light blue-top tubes contain
sodium citrate, green-top tubes contain sodium or
lithium heparin, lavender-top tubes contain potassium
EDTA). Consult the individual test specimen requirements to determine the correct additive/tube to use. Collect a volume of blood that is at least 2–2 1/2 times
the volume of plasma needed for the test. Fill the tube to capacity, since partial filling will result in dilution of the sample. Do not overfill the tube since it will result in
a lower concentration of anticoagulant and activation of clotting. Under filled or overfilled collection tubes are not acceptable for testing.
1. Following the blood collection, immediately mix the tube by inverting the tube gently four (4) times when using light blue-top (sodium citrate)
tubes (further inversions might cause activation of clotting factors) and eight (8) times for all others.
2. Centrifuge for at least 15 minutes in rotor/speed combination that produces at least 1500 RCF (Relative Centrifugal Force) within one hour of collection.
3. Transfer plasma to a properly labeled clean plastic screw-cap vial and attach the label from the lower portion of the test requisition, if applicable. Do not transfer red cells to the vial. Cap firmly to prevent leakage.
4. Write “PLASMA” on the plastic screw-cap vial label and on the test requisition.
Platelet Poor Plasma
1. Collect blood in a light blue-top (sodium citrate)
tube and mix the tube by inverting the tube gently four (4) times.
2. Centrifuge for at least 15 minutes in rotor/speed
combination that produces at least 1500 RCF
(Relative Centrifugal Force).
3. Using a plastic pipette, remove plasma taking care to avoid the buffy coat layer containing leukocytes and platelets. Transfer to a plastic tube.
4. Centrifuge for at least 15 minutes in rotor/speed
combination that produces at least 1500 RCF.
5. Using a new plastic pipette, remove the plasma taking care to avoid the layer at the bottom of the tube. Transfer plasma to a properly labeled clean plastic screw-cap vial and attach the label from the lower portion of the test requisition, if appli
cable. Cap firmly to prevent leakage.
6. Write “PP PLASMA” on the plastic screw-cap vial label and on the test requisition.
Serum
For most analyses performed on serum other than
therapeutic drug monitoring, we recommend the use
of plastic Serum Separator Tubes (SST®s). Please
check individual specimen requirements for restrictions. SST®s should not be used to collect specimens
for some therapeutic drug monitoring and toxicological analyses.
1.
2.
Perform venipuncture as with any other blood
collection device.
Collect a volume of blood that is at least 2–2 1.2 times the volume of serum needed for the test in an appropriate collection tube. Fill the tube to
capacity, since partial filling will result in higher
serum concentration of tube additives, which are
known to alter the results of some tests.
3. Immediately mix by inverting the tube gently 5 times.
Less than five inversions will result in incomplete clotting and incomplete separation of red cells from serum. Hemolysis of even a small number of red cells remaining above the gel in contact with serum will spuriously elevate results of tests such as serum potassium and lactate dehydrogenase.
4. Do not remove the stopper at any time. Do not
centrifuge immediately after drawing blood.Allow the blood to clot in an upright position for at least 30 minutes, but not longer than 1 hour before centrifugation.
5. Centrifuge for at least 15 minutes in rotor/speed
combination that produces at least 1250 RCF
within one hour of collection.
6. Transfer the clear serum to a properly labeled plastic screw-cap vial. Attach the label from the lower portion of the test requisition, if applicable.
7. Write “SERUM” on the plastic screw-cap vial label and on the test requisition.
Therapeutic Drug Monitoring or Toxicological Analysis
Do not use Serum Separator Tubes (SST®) for therapeutic drug monitoring or toxicological analysis. The polyester in the separator gel can extract lipophilic substances
(most drugs), and can cause a falsely low drug concentration result. Instead, collect the specimen in a plain
red top tube containing no gel. Collect and process as
described above and after centrifugation, transfer the
serum with a pipette to a properly labeled plastic vial.
Serum should be clear and free of red cells.
Frozen Serum or Plasma Specimens
Serum or plasma specimens need to be frozen when
specifically stated. It is essential to freeze the plasma or serum as soon as it is separated from the cells and
transferred to a plastic vial. Do not freeze specimens in glass tubes; always freeze them in plastic vials or
tubes—unless instructed otherwise. Do not freeze plastic Serum Separator Tubes (SST®s).
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Lay the tube at a 45° angle to avoid tube breakage
caused by expansion during freezing. Hold the
specimens before pick-up in a freezer or dry ice
container. Do not use frost-free freezers. The automatic defrost cycle will cause the specimen to
partially thaw, and then freeze again. The results of
many tests are affected by such freeze-thaw cycles.
Extreme cold may cause ordinary plastic labels to
become brittle and detach from the specimen tube.
Use clear tape to secure the label to a specimen
transport tube.
If more than one test is requested on a frozen
specimen, split the sample prior to freezing. Use
separate test requisitions when submitting more
than one frozen sample; frozen and nonfrozen
specimens must not be submitted on the same test
requisition. Indicate on the specimen container and
on the test requisition whether a specimen is
plasma or serum.
If more than one test is ordered on a single frozen sample, only one of the tests requested will be
performed. We will call you to choose which test you want performed before testing can proceed.
Common Causes of Unacceptable Blood
Specimens and Inaccurate Test Results
Hemolysis
Hemolysis occurs when the membrane surrounding
red blood cells is disrupted and hemoglobin and other intracellular components escape into the serum or plasma.
Hemolyzed serum or plasma varies in color from faint pink
to bright red, rather than the normal straw color. Grossly
or moderately hemolyzed specimens may necessitate a
new sample for some tests. Even slight hemolysis that
might not be obvious on visual examination of the serum,
or plasma, may significantly alter certain test results, e.g.,
serum potassium and serum LD. Refer to the General Test
Listing section for the particular test to determine the effect of hemolysis.
Hyperbilirubinemia
Icteric serum or plasma varies in color from dark to bright
yellow, rather than the normal straw color. Icterus may
affect certain test results and might necessitate a new
sample to assure results of diagnostic value.
Turbidity (Lipemia)
We recommend that patients fast for at least 8 hours
before a blood specimen is obtained. Eating prior to blood
collection produces a transient presence of fatty substances (lipids) in the blood resulting in turbid, cloudy or milky
serum. Moderately or grossly lipemic specimens may alter certain test results (See Fasting Requirements in the
Patient Preparation and Specimen Transport section).
24
Urine chemistry tests
Table 1: Urine chemistry preservatives and Requirements
Test code
Transport temperature
Preservative
Test name
Random
Random
24-Hour
urine with urine
with
Creatinine without
Creatinine
Creatinine
24-Hour
Room
without
temperature
Creatinine (3)
Refrigerated
Frozen (4) 6N
HCI
Aldolase
X
6516
X
X
X
P
A
X
P
Amylase
8464
X
X
212
P
A
A
X
X
Beta-2 Microglobulin
X
4944
X
X
X
A
P
X
X
Calcium
1633
X
1635
11313
P
A
A
P
A
Calcium, Pediatric
11216
X
X
X
P
A
A
P
X
Catecholamines
5244
X
39627
318
P
A
A
P
X
Catecholamines and
VMA
X
X
39626
X
P
A
A
P
X
Collagen Cross-Linked
N-Telopetide
36167
X
36421
X
X
P
A
X
X
Cortisol, Free
X
X
14534
370
P
A
A
X
P
Cortisol, Free (LC/MS/
MS)
X
X
11280
X
X
A
P
A
P
Immunofixation (IFE)
X
213
X
X
X
A
A
X
X
X
36088
X
X
X
R
X
X
Kidney Stone Formation,
Diagnostics Panel®
Boric
acid
Kidney Stone Formation,
Therapeutic
Monitoring®
X
X
37364
X
X
X
R
X
X
Metanephrines,
Fractionated
6016
X
X
641
P
A
A
P
X
Metanephrines,
Fractionated,
(LC/MS/MS)
14961
X
X
14962
P
A
A
P
A
Porphyrins,
Fractionated®
36592
X
729
X
X
P
A
X
X
Protein, Total and
Protein Electrophoresis
8525
X
750
X
P
A
A
X
X
Urinalysis with Reflex to
Microscopy
7909
X
X
X
P
A
X
X
X
Vanillylmandelic Acid
(VMA)
1710
X
39517
934
P
A
A
P
X
* Acid washed containers are available from your local laboratory.
Refer to entries in General Test Listing for more specific instructions.
•
•
•
•
Thyrol required
Protect from light
<32oC
- 15 to 20oC
R = Required
P = Preferred A = Acceptable
X = Not Available /
Not Applicable
25
Urine
Random (Spot) Urine
The normal composition of urine varies considerably
during a 24-hour period. Submit a first morning
voided specimen whenever possible because it has a
more uniform volume and concentration; its lower pH
helps preserve formed elements. To reduce contamination, the specimen submitted should be a “mid-stream” sample. Urine for hCG (“pregnancy”)
testing should be first morning void, or a random
specimen with a specific gravity of at least 1.010.
Note the time of collection of the specimen on the
test requisition and on the container label. For some
urine tests, there are dietary restrictions. For others,
some drugs must be avoided prior to obtaining the
specimen. This information is included as part of the
specimen requirements for the individual tests in the
General Test Listing section in this Guide. Since the
concentration of urine varies widely, a convenient
way of normalizing test results is to divide the result
by the concentration of creatinine in the same
aliquot. The amount of creatinine excreted daily in
the urine is fairly constant (around 1 gram per day)
and thus, the amount of creatinine in a random/spot
sample is a good estimate of the fraction of the total
daily urine volume that the random/spot sample
represents. For specific urine tests that are reported
as a creatinine ratio, see General Test Listing in this
Guide.
Urinalysis
Specimens must be submitted in a yellow-top
preservative tube. This tube cannot be used for urine culture. To reduce contamination, the specimen submitted for urinalysis should be a
mid-stream sample. See Urinalysis in General Test
Listing of this Guide for specific information.
24-Hour Urine
Proper collection, preservation and accurate measurement of the volumes of 24-hour urine
26
specimens are essential for accurate test results. Patients should be carefully instructed in the correct
collection procedure. Printed instructions for the patient and appropriate containers are available from
Quest Diagnostics through Client Services.
1. Unless the physician indicates otherwise, instruct the patient to maintain the usual amount of liquid intake, but to avoid alcoholic beverages.
2. During the collection period, place the 24-hour urine container (with appropriate preservatives, if applicable) in a refrigerator or cool place to prevent growth of microorganisms and possible decomposi-
tion of urine constituents. See specimen requirements for the individual tests in General Test Listing in this Guide for information on required preservatives, if any.
3. Have the patient empty his/her bladder in the morning into the toilet (not to be included in the 24-hour collection). Write the date and time of voiding on the container label.
4. Collect the patient’s next voiding and add as soon as possible to the 24-hour container. For trace element analysis (e.g., heavy metals), the patient should urinate directly into the 24-hour container to avoid contamina-tion of the sample.
5. For analyses requiring the addition of 6N HCl, add the acid at the start of collection. Have the patient collect each void in a smaller container and carefully pour the urine into the 24-hour container to avoid splashing and possible acid burns.
6. Add all subsequent voidings to the container as in (4). The last sample collected should be the first specimen voided the following morning at the same time as the previous morning’s first voiding, which was discarded.
7. Mix the contents of the container gently but thoroughly. Examine to help ensure that the contents appear homo geneous.
8. Measure and note the total volume of urine.
9. Transfer the required aliquot to the plastic screwcap
specimen container.
10.Record the total 24-hour urine volume on the specimen container and on the Test Requisition before sending to the laboratory.
11. If necessary, refrigerate the aliquot until it can be sent to the laboratory. For frozen specimens, freeze before packing in dry ice for transport. (See Frozen Serum or Plasma Specimens in this section.)
12.Ensure the lid is properly tightened to prevent leakage.
Stool
Stool Collection for Chemistry Tests
1. Carefully read the specimen requirements in the General Test Listing section.
2. Collect timed specimens in a pre-weighed, well-sealed container.
3. At the end of the collection period, determine weight of the total sample.
4. Mix contents of timed sample well to obtain a homogeneous mixture.
5. Remove the required aliquot to a screw-cap plastic container and seal well.
6. Record the total weight and collection time of the sample on both the sample container and the test requisition.
Do not send the entire collection unless instructions
for a specific test indicate otherwise.
Stool Cultures and Other Microbiological Tests:
Refer to the Bacteria section in this Guide.
Stool Samples for Ova and Parasitology: Refer to the
Parasitology section in this Guide.
27
Bacteria
General Submission Requirements
Successful isolation of potential pathogens depends
upon specimen selection and collection, proper
transport and timely delivery to the laboratory. It is
extremely important to refer to respective specimen
collection and submission instructions in this Guide.
Please indicate the source of the specimen on the
test requisition, when appropriate, to better enable
us to assist you in your diagnosis and treatment.
Please see General Test Listing in this Guide for additional instructions. Not all specimens contain
clinically significant pathogens. Organism identification and anti-microbial susceptibility studies will
be performed only on appropriate isolates at an additional charge.
•
•
•
Specimen collection from normally sterile sites requires a needle puncture or a surgical procedure to decrease the chance for contamination. Do not submit syringes with needles attached. If a syringe must be submitted, remove needle, expel air and re-cap syringe.
Because specimens are routinely collected through contaminated pathways, the quality of culture results is directly dependent on the collection technique for urine, sputum, specimens from the nasopharynx and wounds.
Specimens from sites such as skin, mucous mem-
branes and the gastrointestinal tract are popu-
lated by indigenous microflora. Microbiological tests will be directed at the isolation of specific pathogenic agents.
Temperature
Appropriate storage and transport temperatures for
clinical specimens are essential for successful isolation of organisms. If room temperature is required
for a specific test, do not place the specimen in an
environment where it would be exposed to extremes
of heat or cold, so that fastidious organisms have a
better chance of survival. Refrigerated temperature
can be maintained using a household or commercial refrigerator (that is not used to store food) or a
28
cooler with cold packs. If refrigeration is requested, do
not freeze the specimen. Frozen samples may be stored
in a household or commercial non frostfree freezer (that
is not used to store food) at –20°C until transported to
the laboratory. C. difficile toxin analysis and certain virology specimens require storage at –70°C.
Specimen Rejection Criteria
When preparing to submit a specimen, please avoid the
following conditions that will cause the specimen to be
rejected or delayed in processing:
•
•
•
•
•
•
•
•
•
•
•
Improper or no labeling
Prolonged transport time beyond stability limits
Improper container
Leaking container: sputum, blood, body fluid, etc.
Oropharyngeal contamination
Multiple test requisitions submitted with the same source, day and test requested, except for blood cultures, stools for parasite exams and specimens for occult blood analysis
Transportation temperature inappropriate for request
Quantity not sufficient for testing (QNS)
Colostomy discharge, Foley catheter tip or emesis
Use of aerobic swabs for anaerobic culture
Swab transport systems and preservatives used be
yond expiration date
Swab and Vial Transport Systems
•
•
Quest Diagnostics recommends rayon tipped swabs in transport systems containing Amies liquid or gel transport media, in plastic tubes with different colored caps. The swabs in gel transport systems may be used to culture for aerobic and/or anaerobic organisms. Liquid transport systems are intended for use only with aerobic culture or antigen detec-
tion tests and should not be used for anaerobic culture. After collection, plunge the swab into the liquid or gel transport media to prevent drying. Transport at room temperature.
Port-A-Cul® gel vials are appropriate for liquid or tissue specimens submitted for aerobic and/or anaerobic cultures. See more detailed instructions in the Anaerobic Cultures section below.
•
•
•
Mini-tip culture swabs with a thin flexible wire shaft are used to collect nasopharyngeal and male urethral specimens.
Some organisms require use of swabs constructed of certain materials and special transport media, e.g., use only Dacron®, or rayon, or flocked nylon swabs for Bordetella pertussis, transported in Regan-Lowe medium.
Tests for the detection of bacterial nucleic acids require special collection and transport systems.
Smear Preparation
For some specimens, smears may be prepared at the
time of collection and sent to the laboratory for Acid
Fast stain, Gram stain, or Direct Fluorescent Antibody (DFA) stain. The Gram stain may be very useful
for the rapid, presumptive identification of infectious
agents and to judge the quality of the accompanying
specimen. DFA stains are helpful in rapidly identifying the presence of antigens from certain specific
organisms. When submit-ting a smear:
• Handle the specimen using universal precautions, including wearing latex gloves and using a biologi-
cal safety cabinet when there is chance of aero
solization of the specimen.
• Prepare smears by placing a small drop of puru
lent or blood-tinged material from the specimen near one end of a clean, new glass slide. Touch the short side of a second slide to the drop so the drop spreads across the width of the first slide. Use the second slide to gently draw the sample length-wise toward the opposite end of the first slide. Proper preparation should lead to a monolayer of cellular material and bacteria that are still dense enough to readily demostrate organisms.
• In general, do not attempt to make smears from body fluids that require centrifugation.
• If the specimen is collected with a swab, it is necessary to perform such collection procedures using two swabs. Use one swab to inoculate cul
ture transport media and the second swab to make the smear. Roll the swab gently across the slide to avoid destroying host cells and since slides are not usually sterile
• Air-dry smear. Do not fix with cytology fixative.
• Send smear in a plastic slide holder, or if none is available, in a cardboard slide holder.
Transport of Bacterial Isolates
When sending an isolate in culture media to the laboratory for identification and/or antibiotic susceptibility
testing, please follow all current statuatory requirements
for transportation for biohazardous material. The requirements include packaging the organism in a doublewalled
container. All isolates must be submitted on an agar slant
in a screw-capped tube. Bacterial isolates should be submitted on Typticase soy agar with or without blood,
and fastidious organisms should be sent using Chocolate
agar slants. Anaerobic organism may be sent in Chopped
Meat Glucose or Thioglycollate Broth. All tubes, vials,
and bottles must be appropriately labeled, tightly capped
and sealed with tape or parafilm. DO NOT SUBMIT
PETRI DISHES.
•
•
•
•
Each isolate to be transported must be placed in a Tape Seal 95kPa Specimen Transport Bag with the Absorbent Sheet pre-inserted in the bag.
Insert the specimen into the bag through the slit. Remove the adhesive backing from the tape seal area.
Fold bag at slit and align lines so that they correspond.
Then, place the bag on a solid flat surface and press hard at the center of the tape seal area while
maintaining this pressure, slide hands outward to the edges to seal.
• Indicate the organism suspected, as well as, relevant patient history on the requisition. See Infectious Sub
stances in the Transporting Specimens to Quest Diagnostics section.
29
Specimen Requirements
Infective Endocarditis
This section is organized alphabetically by anatomic
site, starting with blood cultures. For each site, collection instructions for general bacteriology are
followed by specific information for the isolation
of mycobacteria, of fungus and, in some cases, of specific pathogenic bacteria.
• Acute: Obtain 3 sets of blood cultures during the first 1–2 hours of evaluation.
• Subacute: Obtain 3 sets of blood cultures on the first day (ideally 15 or more minutes apart, the same veni puncture site may be used). If all 3 sets are negative, obtain 2 additional sets of cultures.
• Culture-negative endocarditis: Consult with the Quest Diagnostics Medical Director, after 5 negative sets of blood cultures. Special culture techniques may be advised.
Blood Cultures
Labeling
Label all culture bottles with the patient’s name, date and collection time and, if a specific agent is
suspected, with “Rule out <name of microorganism>”. Avoid putting the label on the bottle barcode
& expiry date.
Timing
We recommend the following guidelines for the
timing of the collection of blood cultures and optimal
recovery of microorganisms present.
Before the use of systemic antimicrobials, obtain 2
separate sets of blood cultures when there is a fever
(exceeding 38°C or 100°F) combined with significant
leukocytosis or leukopenia. Most often, two separate sets of blood cultures will suffice. More may be
required to confirm certain suspected diagnoses.
Systemic and Localized Infections
•
•
•
30
Suspected acute sepsis, meningitis, osteomyelitis, arthritis, or acute, untreated bacterial pneumonia: Obtain 2 sets of blood cultures.
Fever of unknown origin: Initially, obtain 2 sets of blood cultures; 24–36 hours later obtain 2 addi-
tional sets of blood cultures. Note: The yield beyond 3 sets of blood cultures is often negligible except in patients with suspected typhoid fever, brucellosis, and infective endocarditis.
Suspected early typhoid fever or brucellosis: Owing to the lowgrade bacteremia present in these infections, obtain 4 sets of blood cultures (the same venipuncture site may be used) over a 24–36 hour period.
Blood Culture Bottles
Since these cultures are processed using special media and instrumentation, it is necessary to submit all of these cultures in the correct BD BACTEC bottles.
For adults, use BD BACTEC Plus Aerobic/F (silver label
with graytop) and BD BACTEC Lytic/10 Anaerobic/F
(purple label and cap) bottles. For children, use a BD
Peds Plus/F Aerobic bottle (silver/pink cap).
Precaution: Broth in the bottle should be clear. Do not
use bottles containing broth that is cloudy. Do not use
bottles beyond expiration date. An aerobic bottle and an
anaerobic bottle filled from a single venipuncture or collection site should be interpreted as a single culture
set. For example, if a physician orders two separate
sets of blood cultures, the phlebotomist would use two
separate venipuncture sites, drawing one culture set
from the right arm and one culture set from the left arm;
in most cases, both sets may be obtained at the same
time. Preferably, blood for culture should not be drawn
through an indwelling or intraarterial catheter. Draw the
sample for each set of blood cultures (10 mL per bottle
is optimal from adult patients and 5 mL per bottle from
pediatric patients) with a needle and syringe or a closed
system consisting of a vacuum bottle and double needle collection system.
Phlebotomy for Blood Cultures
After palpation, scrub the venipuncture site with 70%
alcohol for a minimum of 30 seconds.
1. Apply iodine/iodophor (1–2% tincture of iodine or 10% providoneiodine) for 60 seconds in concen-
tric circles away from the venipuncture site cover-
ing an area 11.2–2 inches in diameter. After the puncture site has been decontaminated, do not touch. If the patient is allergic or sensitive to iodine, cleanse with 70% alcohol only. Scrub for 60 seconds and let dry completely.
2. Decontaminate the diaphragm bottle tops by swabbing with 70% alcohol. Allow it to dry. Do not use iodine on the diaphragm tops. If further palpation of the vein is needed, disinfect the finger of the glove or use a sterile glove.
3. Using a syringe and needle or a “butterfly” double needle collection system, perform veni
puncture and obtain 20 mL of blood (if an adult patient), 10 mL of blood (if a pediatric patient weighing 13.5–13.5 kg) and inoculate bottles as described below.
4. Following venipuncture, remove iodophor that can irritate the skin of patients with 70% alcohol and allow to evaporate.
5. Do not overfill bottles. Greater than 12 mL in the adult bottles and greater than 5 mL in the pediatric bottles constitute overfills.
Blood Culture Volumes
Adult: Inoculate 10 mL each into BD BACTEC® Aerobic/F and Lytic/10 bottles. If you cannot obtain
20 mL of blood, divide as follows:
•
•
Less than or equal to 8 mL: transfer entire amount to BD BACTEC® Plus Aerobic/F bottle (silver label with gray-top).
Greater than 8 mL, but less than 20 mL: transfer 8–10 mL to BD BACTEC® Plus® Aerobic/F bottle and the remainder to BD BACTEC® Lytic/10 Anaerobic/F bottle (purple label and cap).
Pediatric Patients weighing 30– 80 lbs: If you cannot
obtain 10 mL of blood, divide as follows:
• Less than or equal to 5 mL: transfer entire amount to a BD Peds Plus®/F Aerobic bottle (silver/
pink cap).
•
Greater than 5 mL, but less than 10 mL: transfer no more than 5 mL to a BD Peds Plus™/F Aerobic bottle (silver/pink cap) and the remainder to BD BACTEC® Lytic/10 Anaerobic/F bottle (purple label and cap). Although pediatric patients are smaller than adults, they can have 2–3% of their blood volumes sampled for testing. It should be safe to collect 6 mL, 23 mL, and 60 mL of blood from pediatric patients respec
tively weighing 2.1–12.7 kg, 12.8–36.3 kg, and greater than 36.3kg. These blood volumes represent no more than 3% of the patients’ total blood volumes and usually less.
Mycobacterial Blood Cultures
Submit blood for mycobacterial cultures in either yellow top (sodium polyanetholesulfonate [SPS]), green-top (heparin) or Isolator® tubes. Gently mix the
tube(s) following inoculation. Do not vent or refrigerate.
Fungal Blood Cultures
Submit blood for fungal culture in SPS or sodium heparin
tubes, BD BACTEC® Aerobic or BD BACTEC® Myco® F/
Lytic blood bottle(s) or Isolator® tubes (not supplied by
Quest Diagnostics). Gently mix the bottle(s) and tube(s)
following inoculation. Do not vent or refrigerate.
Storage and Transport
Prior to pick-up, keep the blood culture bottles or tubes
at room temperature away from direct sunlight and/or
ventilation sources. If pick-up is delayed, do not refrigerate or incubate the bottles or tubes.
The bottles or tubes must be stored at room temperature. They are stable for up to 48 hours.
Mycobacterial Body Fluid Cultures
1.
2.
3.
Follow skin decontamination procedure outlined in Anaerobic Cultures.
Submit 10–15 mL of non-bloody fluid in a leak-proof sterile screwcap plastic container. If the specimen is bloody, collect it in a yellow-top (sodium polyane
tholesulfonate [SPS]) or green-top (heparin) tube.
Store and transport refrigerated.
31
Genital specimens
General
• The anatomic site determines which specimens may be appropriate for aerobic or anaerobic culture. Only genital specimens listed in the “Specimens Acceptable for Anaerobic Culture” section are appropriate for anaerobic culture.
• Collect genital specimens using a rayon tipped culture swab containing gel. After collection, plunge the swab into the gel transport medium to prevent drying. The swab may be used to culture urethral exudate or inflammation of the vaginal area. Specimens should be stored at room temperature until and during transport to the laboratory. Do not refrigerate.
• If either Group B Streptococci or Neisseria gonorrhoeae is suspected, order cultures for these specific organisms because these tests require special conditions. Alternatively, order antigen or nucleic acid tests for these organisms.
Vaginal
Separate swabs should be used for tests other than G. vaginalis, e.g., culture or microscopic slide samples.
Cervical
1. Do not use lubricant during the procedure.
2. Wipe the cervix clean of vaginal mucus.
3. Obtain exudate from the endocervical glands and os by using a culture swab. Rotate the swab in the cervical os.
4. Remove the swab carefully, avoiding contact with the walls of the vagina.
5. After removal, plunge the swab into the gel trans
port medium to prevent drying.
6. Specimens should be stored and transported at room temperature. Do not refrigerate.
Urethral
1. Collect specimen at least 2 hours after the patient has urinated.
32
2. Insert a yellow cap, mini-tip culture swab with a thin, flexible wire shaft 2–4 cm into the urethra, gently rotate it, leave it in place for 1–2 seconds and with draw the swab.
3. Place mini-tip swab into its gel transport device
4. Specimens should be held and transported at room temperature. Do not refrigerate.
Vaginal and Rectal Group B Streptococci
•
•
•
•
The Center for Disease Control (CDC) recommends culturing both the vagina and rectum of pregnant women at 35–37 weeks of gestation for Group B streptococci to help identify neonates that are at increased risk for infection.
A vaginal introitus swab and an anorectal swab or one swab inserted first into the vaginal introitus and then into the anorectum should be collected. Cervical specimens are not appropriate for this test.
Antimicrobial Susceptibility Testing is not routinely performed on Group B Streptococcus, but may be indicated in penicillin allergic patients. A special version of the Group B Streptococcus culture, which includes susceptibility testing for use in these allergic patients, is available. In case this special test was not ordered by mistake, susceptibility testing can be added by calling the laboratory within 3 days.
Use red or blue cap rayon, Dacron® or flocked nylon swabs containing liquid or gel transport medium. Store and transport swabs at room temperature; the swabs are stable for two days. Do not refrigerate.
Cervical, Vaginal and Urine Specimens for N. gonorrhoeae
Neisseria gonorrhoeae (GC) Culture
• Order culture specific for Neisseria gonorrhoeae.
• Use only the Amie’s transport culture swab as described in Urogenital Cultures, General Test Listing section.
• Transport at room temperature. Do not refrigerate.
• Transport to the laboratory as soon as possible; specimens for gonorrhoeae in the gel medium are stable only for one day.
Nasopharyngeal Specimens
Nasopharyngeal secretions obtained by aspiration,
washings or flexible, twisted wire mini-tip culture
swabs are the preferred specimens in order to avoid
contamination with nasal or oral flora.
To obtain specimen using yellow cap mini-tip culture swabs with a thin flexible wire shaft, immobilize patient’s head and insert swab through a nostril.
Push forward using gentle downward pressure to
keep the swab on the floor of the nasal cavity until
the tip reaches the posterior wall of the nasopharynx.
Rotate gently for a few seconds and remove. Submit
swab in transport medium. Store and transport specimen at room temperature (stable 2 days). Do not refrigerate.
The most sensitive test for Bordetella pertussis/ parapertussis is DNA, Qualitative, Real Time PCR.
Specimens may be collected using a plastic shaft,
minitip, rayon or Dacron® swab. Do not use calcium alginate swabs. Swab both nostrils. After the
specimens are collected, place the swabs in a sterile
screw-cap vial containing 2mL of sterile saline and
tighten lid well.
For Bordetella pertussis culture, submerge calcium
alginate, flocked nylon, Dacron® or rayon swab, or
inoculate aspirate or washings, into Regan-Lowe medium. Simultaneous direct fluorescent antibody
(DFA)stain microscopy and culture for Bordetella is
more sensitive than culture alone. If a DFA stain is
desired, submit 2 slides with 2 smears on each slide,
air-dried. Hold and transport specimens refrigerated
(stable for 2 days).
Throat Cultures: Streptococcus, Group A
Group A, beta hemolytic Streptococcus (GAS) cause
most cases of pharyngitis. Serious systemic sequelae
of untreated GAS infection include glomerulonephritis and acute rheumatic fever. Uncommon, acute
life-threatening diseases associated with untreated
pharyngitis include peritonsillar or retropharyngeal
abscesses, diphtheria and epiglottitis, which may
cause acute complete obstruction of the airway.
Airway management should be considered prior to
throat culture in these patients.
Once the life-threatening diseases discussed above have
been considered and ruled out, initial laboratory evaluation is typically directed toward GAS diagnosis. The
incidence of GAS is highest in children and young adults
between the ages of 5 and 21 and in the fall through
spring months. Up to 40% of patients in that age group
with pharyngitis have GAS when presenting in those
months. These patients should have either a specific
culture for Streptococcus, Group A performed or Strep to coccus Antigen, Group A with Reflex to Culture.
Negative Rapid Streptococcus Antigen tests should always be reflexed to a GAS culture. Aside from GAS,
other pharyngeal diseases either can be diagnosed clinically or through the use of organismspecific cultures
or other confirmatory tests. The GAS culture has been
chiefly structured to detect GAS, but may also identify non-Group A beta hemolytic Streptococci, such as
groups C and G that are also clinically significant. The
use of a routine or “full” throat culture for patients presenting with pharyngitis is limited, but it may be useful in detecting agents of epiglottitis and thrush.
Arcanobacterium haemolyticum and Groups C and G
Streptococci have also been associated with acute pharyngitis. If infection with A. haemolyticum or nonGroup A Streptococci is suspected, consider ordering a
routine throat culture. Immunocompromised patients,
patients post head and neck surgery and patients with
persistent pharyngitis after antibiotic therapy may also
benefit from a routine throat culture.
• Use a sterile aerobic culture swab to sample the back of the throat (posterior pharynx), tonsillar crypts, and between the tonsillar pillars and uvula. Avoid touch
ing the lips, cheeks, tongue and uvula. Throat speci
mens should not be collected if the patient may have epiglottitis.
• Streptococcus, Group A Culture: collect with a rayon, Dacron® or flocked nylon culture swab in Amies liquid transport medium. Other liquid transport media are acceptable.
• Throat Culture: collect with a rayon, Dacron® or flocked nylon swab and transport in liquid or gel transport medium. Other liquid transport media are acceptable.
33
• Streptococcus Antigen, Group A with Reflex to Culture: collect with a dual culture swab or two single culture swabs. Do not use gel transport medium swabs for the Antigen test. Store and transport throat culture swabs at room temperature.
Sputum and Lower Respiratory Tract
Specimens for Routine Bacteriology,
Mycobacteriology (AFB) and Fungal
Cultures
1. The preferred sputum specimen is an early morning expectorated sample obtained after a deep cough. Do not pool multiple samples. The patient should rinse mouth with water before sputum is collected. Instruct the patient to avoid adding saliva or nasopharyngeal discharges to the sputum sample to avoid contamination by indigenous microorganisms. Collect the expecto
rated sputum in the leak-proof container provided by the laboratory (sterile 50 mL conical centrifuge tube or a sterile screw-cap cup). Twist the cap securely closed after placing the specimen in the container.
2. Collect lower respiratory tract specimens by bronchos copy or transtracheal aspiration avoid
ing contamination by oropharyngeal flora. Tightly secure transtra cheal aspirate, bronchial lavage or bronchial alveolar lavage traps or containers before submitting to avoid leakage during transport.
3. For mycobacterial culture, it is recommended that three separate sputa specimens be collected over three consecutive days. Submit each specimen separately; do not pool them. Induced sputa may also be submitted, but must be labeled as such.
4. Requests must be specific for bacterial or mycobacterial culture.
5. Swabs of sputum or lower respiratory specimens are not appropriate for routine bacteriology, mycobacteriology or fungal cultures.
6. All mycobacteria culture isolate samples from clients for further testing should be sent to the Microbiology department (BSL-3 level-Mycobac-
teriology laboratory).
34
Sputum and Lower Respiratory Tract Specimen Transport
Double bag the specimen and refrigerate or place it on
cold packs until the specimen is picked up or it is delivered to the laboratory.
Stool Specimens for Culture
The organism(s) to be cultured should be specified on
the test requisition.
Stool cultures cannot be performed on specimens
submitted in Ova and Parasite (formalin and PVA,
zincpolyvinyl alcohol) vials. If the first culture specimen
yields negative results a second and, in rare cases, a third
specimen collected at 1–3 day intervals will increase the
probability of isolating a pathogen.
Stool Specimens for Salmonella, Shigella, Campylobacter, Yersinia or
Vibrio, and/or to Rule Out Other Bacteria
1. Collect the stool specimen in a clean, dry container (do not use a toilet).
2. Open the transport vial containing Cary-Blair transport medium.
3. Using the collection spoon built into the lid, obtain scoops of stool from areas that appear bloody, slimy, or watery and place them into the vial until the volume rises to the red line. If the stool is formed (hard), sample small amounts from each end and the middle.
4. Mix the contents of the vial with the spoon, twist the cap tightly closed, and shake until the contents are well mixed.
Stool Specimens for Rotavirus
See Stool in the Virus section of this book.
Occult Blood in Feces
Precautions
See Test for the Detection of Blood in Feces in the
Blood, Urine and Stool section of this book.
•
•
•
Urine Cultures
Urine Bacterial Culture Transport Kit
Quest Diagnostics recommends a urine collection kit
containing a gray-top tube with preservative that
prevents rapid multiplication of bacteria in the urine
during transport, which could cause colony counts to
be erroneously high. Instructions for Use (also
printed on the specimen transport kit)
1. Obtain the urine specimen from the patient in a clean container (a clean, dry plastic paper or waxed-paper cup is recommended and will not contaminate the specimen). If collecting for both urinalysis and culture, it is recommended that at least 20 mL of urine be collected.
2. Either glass or plastic tubes are acceptable. Open the pouch of the “Vacutainer® Brand Urine C&S” or “Vacutainer® C&S: Preservative Plus” Plastic Tube Transport Kit and remove the transfer device and tube. See Specimen Collection Tubes chart inside the front cover.
3. Submerge the straw of the transfer device to the bottom of the urine container. The container may be tipped at an angle if the volume of urine is limited.
4. Place the gray-top transport tube in the holder portion of the transfer device and push it down as far as it will go, puncturing the stopper.
5. Hold the tube and transfer device in position until the urine stops flowing into the tube.
6. Remove the transport tube from the transfer device and vigorously shake the tube.
7. Discard the transfer device and remaining cup of urine into appropriate biohazard disposal containers.
8. Immediately send to laboratory at refrigerated or room temperature (stable 48 hours at both temperatures).
The transport tube should fill approximately to the minimum line indicated on the tube. A tube that is not appropriately filled is unacceptable for culture. (Sometimes with aging, technique or a manufacturing problem, the vacuum inside the tube may not be enough to draw in the appropriate amount of urine.) If inadequate sample is obtained, repeat the tube transfer procedure using a fresh kit that is not close to its expiration date.
The tube and transfer device do not work well unless there is at least 7 mL of urine in the collection cup. If there are only 5–7 mL of urine, remove the tube’s stopper and pour the urine directly into the tube until the minimum fill line is reached. Do not overfill. Replace the stopper as tightly as possible.
If less than 5 mL is available, submit refrigerated urine in a sterile container without preservative.
Routine Urine Culture (Includes Indwelling Catheters)
Patient Preparation
•
•
•
•
Prevention of contamination by normal vaginal, perineal and anterior urethral flora is the most important consideration for collection of a clinically relevant urine specimen.
Obtain early morning specimens whenever possible. There are increased bacteria in the bladder after overnight incubation Symptomatic patients may have lower colony counts if specimens are collected late in the day.
The microbial load in urine may be influenced by fluid intake. Symptomatic patients may have lower colony counts if diuresis is occurring.
Urinalysis and urine culture require two different preservatives; therefore, they require two separate specimens. The urinalysis specimen must be submitted in a yellow-top Urinalysis Transport Tube that has an invisible preservative coating.
35
Patient Guidelines For Clean Catch Urine
Collection
Females
• Wash hands.
• Wash the vulvar area well from the front to the back, using a 5% green soap gauze pad or towelette. Do not use benzalkonium chloride disinfectant as residual disinfectant may cause a false negative test result. Rinse the area from front to the back, using first one moistened gauze pad or paper towelette soaked with either clean, tap, sterile or distilled water, then a second and a third if necessary to remove residual soap.
• Last, dry the area from the front to the back with a dry gauze pad or towelette.
• Discard all gauze pads or towelettes in a waste-
basket.
• With one hand, separate the labia and lean slightly forward so that the urine flows directly down into the toilet without running along the skin.
• After voiding the first portion of the urine, with the other hand, place a clean container under the stream of urine and collect the urine sample. A clean, dry plastic paper or waxed-paper cup is recommended and will not contaminate the specimen. Do not touch the inside of the container.
• Transfer immediately into the urine transport tube, which contains a preservative. Unpreserved urine is unacceptable for routine bacterial culture, except as described in the Precautions section within Urine Bacteria Culture Transport Kit.
Males
• Use a cleansing wipe, a soapy gauze pad or towelette, to wash the end of the penis. Rinse, using first one gauze pad or paper towelette moistened with sterile, tap or distilled water. A second or third rinse may be needed to remove soap.
• Use a clean gauze pad or paper towelette to dry.
36
•
•
•
•
Discard all pads and towelettes into the wastebasket.
Begin to urinate into the toilet.
After voiding the first part, place a clean container under the stream of urine and collect the rest of the urine except the very last part into the container (a clean, dry plastic paper or waxed paper cup is recom- mended and will not contaminate the specimen).
After collection, transfer urine immediately into the urine transport tube, which contains a preservative.
Indwelling Catheters
Specimens obtained from the collection bag are not
suitable for analysis. Disinfect the catheter collection
port with 70% alcohol and allow it to dry. Aspirate at
least 5-10 mL of urine with a sterile needle and syringe.
Transfer the specimen to the urine transport tube.
Foley tips will not be accepted. Swab specimens are not appropriate for urine culture. Ileal conduit urine may be submitted after removing the external device and inserting a catheter into the cleansed stoma for collection.
Fungus cultures
Low Urine Volumes
Urine samples less than 5 mL in volume should not
be placed in graytop urine transport tubes. Instead,
they should be transported refrigerated in a sterile
container. Please indicate the reason for the small
volume of collected urine on the test requisition. Special conditions that necessitate small urine
sample volumes are:
• Infants and small children
• Severe oliguria
• Directed catheterization
Hair, Skin and Nail Fungal Cultures
Specimens for the diagnosis of Tinea should include
both representative abnormal hairs removed with
forceps and scales collected by scraping. Wipe the
affected area with an alcohol swab. Obtain skin
specimens for both dermatophytosis and primary cutaneous candidiasis by scraping the active (advancing) borders of the lesion(s) with a scalpel or glass microscope slide.
For nails, wipe the area with an alcohol swab before
collecting the specimen. Take nail specimens from
the proximal portion of the nail plate and subungual
debris from between the nail plate and bed.
A Calco-fluor white stain will be performed in addition to culture, in order to maximize sensitivity and
rapidly give the clinician useful information.
Blood Fungal Cultures
See Blood Cultures in the Bacteria section.
Respiratory, Lesion and Other Fungal Culture Specimens
Collect other specimen types using techniques previously
described in the Bacteria section. Submit in a leak-proof,
sterile screw-cap plastic container. Urine may be submitted in a urine bacterial culture transport tube. Submit
swabs in Amies liquid transport medium. Store and
transport raw specimens refrigerated. Transport tubes at
room or refrigerated temperature.
Vaginal Specimens for Candida albicans
Refer to the specimen collection instructions for the
Vaginosis/ Vaginitis (Affirm™ VPIII) Screen in Genital
Specimens in the Bacteria section.
Pneumocystis carinii (Pneumocystis jaroveci, PCP)
See Respiratory Tract Parasites in the Parasites section
Do not submit initial nail clippings (tips of nails).
Nail clippings of at least 3 mm in length should be
obtained. This will increase the yield of the culture.
Do not submit specimens if the patient is currently
undergoing antifungal therapy because this may
result in a negative culture. If active antifungal treatment has been initiated, discontinue the treatment
for 5–30 days (based on topical vs. systemic treatment) before taking the specimen. If the first culture
is negative, a repeat culture is recommended if clinically indicated. If the culture continues to be
negative, a biopsy may be indicated.
Place all hair, skin, and nail specimens in a sterile dry
container for transport to the laboratory. Store and
transport at room temperature. Do not refrigerate. 37
Parasitology
Blood Parasites
Malaria, Babesia Species and Trypanosoma
At least one thick and one thin blood film smear
must be submitted on two separate glass slides with
one end frosted in addition to a lavender-top (EDTA)
tube, as described below. Blood for the films should
be taken from a peripheral source such as the finger
during a febrile episode, at 6-hour intervals. If this
cannot be done, at a minimum, submit one lavendertop tube. NOTE: Lavender-top tubes must be transported at room temperature to the laboratory as soon
as possible; the specimen stability is approximately
24 hours after blood collection.
1. To prepare a thick smear from a finger prick, blood specimens should be collected from the tip of the “ring” finger on the palmar surface.
2. Warm the skin area to be punctured.
3. Clean and disinfect skin with gauze squares soaked in 70% alcohol or commercial non-cotton alcohol preparations.
4. Wipe dry with sterile gauze or air dry. Be sure the finger is thoroughly dry prior to pricking.
5. Stick the finger with a sterile disposable lancet, deeply enough to collect a sufficient amount of free flowing blood for film preparation. Do not squeeze finger to remove the blood.
6. Holding a clean glass slide with a frosted end, touch the underside to the puddle of blood that has collected at the puncture site with the unfrosted portion of the slide. Right the slide and allow the thick film to dry.
7. Repeat the procedure and “feather” the blood drop to prepare the thin film.
8. After collection, apply pressure to the puncture site with sterile gauze until bleeding stops and then bandage.
9. Obtain patient history for an aid in diagnosis. This should include travel history and the date of return.
10.Print patient’s name/identification in pencil on the frosted end of the slides.
38
11. Specimens collected after the initiation of drug therapy hamper parasite identification.
12.Transport lavender-top tube and thick and thin smears to the laboratory at room temperature as soon as possible, and no more than 24 hours after collection, avoiding extremes of heat and cold.
Microfilaria (Filarial Worms) Detection in
Blood
• Submit peripheral blood in a lavender-top tube (EDTA).
• If Wuchereria bancrofti or Brugia malayi are suspect
ed, draw blood between 10 P.M. and 4 A.M. If diurnal Loa loa is suspected, draw blood between 10 A.M. and 2 P.M. For Mansonella species, draw anytime.
• Transport to the laboratory at room temperature as soon as possible and no more than 24 hours after collection, avoiding extremes of heat and cold.
Stool Samples for Ova and Parasites (O & P)
Many parasites are passed intermittently. The usual examination for ova and parasites before therapy may include up to three specimens collected at 1–3 day intervals to increase the probability of detecting ova or parasites.
Each specimen must be preserved in one vial of 10% formalin and in one vial of zinc-polyvinyl alcohol (PVA)
with a minimum of 5 grams of specimen in each of
the paired vials. Do not exceed the fill line on the vials.
Formalin preserves helminth ova and larvae. PVA is an
excellent fixative for the preservation of the trophozoite
stages of protozoa.
A comprehensive examination for parasites cannot be made unless both types of preservative vials are submitted. It is important to indicate specimen consistency (formed, soft, loose, or watery) by checking the
appropriate box on the transport vial label.
Patient Guidelines for Stool Sample Collection for O & P
Instructions
• Collect the stool specimen in a clean, dry container. Do not let the specimen touch the water of the toilet.
• Transfer to the transport vials within 30 minutes of collection.
• Open the transport vials.
• Using the collection spoon built into the lid, obtain scoops of stool from areas that appear bloody, slimy or watery and place them into the vial until the volume rises to the red line. If the stool is formed (hard), sample small amounts from each end and the middle. Load to the “fill line” ensuring that the preservative completely covers the specimen.
• Mix the contents of the vial thoroughly with the spoon, twist the cap tightly closed, check the cap to be sure it is secured and shake until the contents are well mixed.
• Keep and transport preserved stool specimens at room or refrigerated temperatures (stable 2 months).
Precautions
• Barium, antibiotics, antimalarials, mineral oil and other laxatives interfere with the detection of intestinal protozoa. Specimens submitted from patients that have been treated with the above must be collected at least 7 days post treatment.
• Specimens should never be frozen or placed in an incubator. Refrigeration is not required.
• Parasite examinations cannot be performed on specimens submitted in stool culture transport vials or any other transport media specifically designed for bacterial pathogens.
• Specimens submitted without preservative will be rejected.
• Do not use kits beyond their date of expiration.
Amoeba
Intestinal amebiasis should be considered in any patient
with protracted diarrhea and in all patients with dysentery. Examination of fresh stool for the presence of cysts
and trophozoites is important and should be carried out
immediately if amebiasis is suspected. If amoebae are
not discovered on a casual stool examination, a purged
stool specimen should be obtained. Because amoebae
tend to be more concentrated in the cecum in light
infections, it is the second and third expulsions (liquid
portions) of the stool, after administration of a purgative
that are most likely to yield amoebae.
1. If a laxative is used, do not use when patient has nausea, vomiting or abdominal pain unless directed by a physician. Do not use in patients with congenital megacolon, bowel obstruction, imperforate anus, or congestive heart failure. Use with caution in patients with impaired renal function, preexisting electrolyte disturbances or those on diuretics, or other medica-
tions that may affect electrolyte levels, or where a colostomy exists.
2. Place the most liquid portion of the specimen into only the PVA container within 30 minutes of collec-
tion. Fill to the fill line.
3. Do not submit formed stool.
4. Store and transport preserved stool specimens at room or refrigerated temperatures (stable 2 months). See Precautions in this section.
Intestinal Parasite (Worm) Identification
•
•
Submit the entire organism in 70% isopropyl alcohol or 10% formalin in a clean, screw-cap container.
Transport at room (<32° C) or refrigerated tempera
ture (stable 2 months).
Parasite Identification (External: Ticks, Larva,
Other Insects)
•
•
Submit the entire organism in 70% isopropyl alcohol in a clean screw-cap container.
Transport at room or refrigerated temperature (stable 2 months)
39
Virus
Selection
This table lists various diseases or syndromes with respective suspected agents with the required specimen to be submitted. The list is alphabetical by disease or syndrome category. Preferred specimen types are listed in bold type.
Disease or Syndrome
Suspected agents
Clinical specimens
Pericarditis/Myocarditis
Enterovirus, Influenza, Adenovirus,
Parainfluenza, Herpes Simplex Virus
Cytomegalovirus (CMV)
Pericardial fluid, Sool (only for Enterovirus),
Throat (HSV) Swab
Pleurodynia
Enterovirus
Stool, Pleural fluid, Throat Swab
Vericella-Zoster
Vesicle Swab, Throat Swab
Cardiac
Exanthema and Rashes
Chickenpox
Zoster (Shingles)
Vericella-Zoster
Vesicle Swab
Herpes Simplex
HSV
Vesicle Swab
Herpangina
Echovirus, Coxsackie A
Vesicle Swab, Throat Swab
Conjunctivitis
Adenovirus, Vericella-Zoster
Chlamydia trachomatis
Conjunctival Swab
Ceratitis
Adenovirus, HSV
Conjunctival Swab, Corneal Scraping
Rotavirus, Adenovirus 40/41
Enterovirus
For Antigen Testing Only
Stool, Rectal Swab
Aseptic Meningitis
Enterovirus, HSV, Mumps
CSF, Stool (only for Enterovirus), Throat Swab
Encephalitis
Enterovirus, HSV, Vericella-Zoster
CSF, Stool (only for Enterovirus), Throat Swab
CMV, HSV
HIV
Urine (only for CMV), Throat Swab, CSF, Orifice Swab Blood
(PCR testing only)
Eye infections
Gastrointestinal
Diarrhea
Nervous system
Perinatal infections
“Failure to Thrive”
Cytomegalic inclusion disease
CMV
Urine, Throat Swab
Herpes
HSV
Vesicle, Mouth, Eye, Throat or Ear Swab, CSF (if indicated)
Pneumonitis
Chlamydia trachomatis, CMV
Respiratory Aspirate, Nasopharyngeal or Throat Swab
Conjunctivitis
Chlamydia trachomatis
Conjunctival Swab
Influenza, Parainfluenza, Adenovirus, Enterovirus,
Respiratory Syncytial Virus(RSV)
Nasopharyngeal (NP) Aspirata, NP Swab, Throat Washing
or Swab, Sputum, Bronchial Washing, Bronchiolitis,
Bronchoalveolar Lavage
Respiratory
Upper and Lower Respiratory Infections
(Including pharyngitis, Croup,
Viral pneumonia and Influenza)
Sexually-Transmitted Diseases
Cervicitis
Chlamydia trachomatis, HSV
Endocervical Swab, Genital Tissue (biopsy)
Epididymitis
Chlamydia trachomatis, HSV
Urethral Swab, Non-gonococcal Urethritis
Non-gonococcal Urethritis
Chlamydia trachomatis, HSV
Urethral Swab, Genital Tissue (biopsy)
Pelvic Inflammatory Disease
Chlamydia trachomatis, HSV
Endocervical Swab, Genital Tissue (biopsy)
Lymphogranuloma Venereum (LGV)
Chlamydia trachomatis
Lymph Node Aspirate, Endocervical Swab, Lesion Swab
Perianal Infection
Chlamydia trachomatis, HSV CMV
Perianal or Rectal Swab
Herpes
HSV
Lesion Swab, Vesicular Fluid, for Asymptomatic
Shedding, Endocervical Swab with a Vulvar Sweep
Condyloma
Human Papillomavirus (HPV)
Endocervical Swab, Genital Tissue/biopsy
(for nucleic acid probe only)
Cervical Dysplasia and Carcinoma
Human Papillomavirus (HPV)
Endocervical Swab, Genital Tissue/biopsy
40
Specimens for virus isolation should be collected
when the virus is at its highest concentration, during
the acute phase of the illness. Virus isolation is carried out by inoculation of specimens onto the appropriate type(s) of cell cultures. In conventional virus
culture, the cell cultures are observed microscopically
for the development of any cytopathic effects (CPE)
that indicate the presence of a virus. The following
viruses can be routinely isolated from a conventional
Comprehensive Viral Culture: adenovirus, cytomegalovirus, enterovirus, herpes simplex virus, VaricellaZoster and influenza A and Influenza B, Parainfluenza
1,2 and 3, adenovirus and Respiratory Syncytial Virus
(RSV). Measles and Mumps virus require a special
request. Conventional culture can take up to 4 weeks.
Alternatively, rapid culture methods for specific virus
that take from 24-72 hours can be ordered. Virus
detection methods including luorescentconjugated
monoclonal antibody stains, and the Enzyme Linked
Virus Inducible System [ELVIS®] are often used to
detect virus replication prior to the development
of CPE. When appropriate, the specific virus or virus
group is identified by supplemental confirmatory
echnique(s). Non-culture methods are also available.
These include direct detection methods: enzyme immunoassay, immunofluorescent assay and nucleic acid amplification techniques.
General Handling
1. We recommend a multi-microbe specimen trans
port medium (M4) for the collection and trans
port of different types of specimens for viral isolation. (This medium will also support vials of Chlamydia, Mycoplasma, and Ureaplasma.) Store the M4 (blue label) tube at refrigerated tempera
tures until inoculated.
2. Do NOT use calcium alginate or wooden shaft swabs for specimen collection; use Dacron® or rayon or flocked nylon swabs on plastic or metal shafts.
3. Write patient identification information and the source of the specimen on the test requisition and on the M4 transport vial.
4. Refrigerate specimens in M4 tube immediately after collection.
5. Keep specimens refrigerated for less than 48 hours, until the courier arrives. If a refrigerator is not available, keep specimen on wet ice or “cold packs” until it is picked up.
6. If submission to the testing laboratory will take more than 48 hours, freeze the sample in M4 tube at –70°C and transport it with enough dry ice to last three days. Freezing at –20°C is not acceptable.
7. Identify and separate virus isolation specimens from other specimens that are to be transported to the laboratory. Inform the courier as to the nature of specimens so that they may be appropriately transported to the laboratory.
Virus Collection Instructions by Specimen Type
Autopsy or Biopsy Specimen
•
•
•
Formalin-preserved or fixed-tissue specimens will not be accepted.
Collect fresh tissue from an appropriate site using a set of separate sterile instruments. Each specimen need not be more than 1–2 cm in diameter.
Place each specimen into an M4 (preferred) or equivalent viral transport medium. If viral transport medium is not available, place tissue into a leak -
proof container. Cover with sufficient sterile saline to prevent drying Refrigerate.
Blood or Serum
Blood and serum are not productive specimen sources
for the isolation of viruses. Amplified nucleic acid methods, (e.g., PCR) are the most sensitive methods available
for detection of many viruses in peripheral blood. Culture
of cytomegalovirus from blood is not available. Quest
Diagnostics offers amplified nucleic acid methods, which
are described elsewhere in this Guide.
For isolation of enteroviruses from serum:
• Collect one red-top tube of blood.
• Separate serum and submit in a plastic screw-capped vial. Do not transfer serum to M4 transport medium.
41
Body Fluids
(Bronchial Lavage, Pleural, Peritoneal, Sputum, etc.)
Collect aseptically. Transfer up to 3 mL (amount
equal to the volume of transport medium in the
specimen container) to the M4 transport medium.
Refrigerate. If M4 transport media is not available,
transport refrigerated in a sterile leak-proof container. Do not freeze unless in M4 transport media.
Cerebrospinal Fluid (CSF)
Collect CSF and transfer up to 2 mL (amount equal
to transport medium) to the M4 transport medium.
Refrigerate. If M4 transport media is not available,
transport refrigerated in a sterile leak-proof container. Do not freeze unless in M4 transport media.
Cervical (Gynecological) Swab
For Herpes Simplex Culture:
1. Swab the endocervix as well as the exocervix with sufficient pressure to obtain epithelial cells.
2. Use an additional swab to perform a “vulvar sweep.”
3. Break swab tip(s) off into M4 transport medium.
Cutaneous/Vesicular Lesion
1. If a vesicle is present, disrupt the vesicle and collect the fluid with a swab. With the same swab, collect cells rom the base of the vesicle by vigorous rubbing.
2. Transfer the swab to a tube of M4 transport medium and break the tip into the medium. Refrigerate.
3. For non-vesicular lesions, vigorously swab the base of the lesion to pick-up infected cells. Break swab tip(s) off into a tube of M4 transport medium. Refrigerate.
Nasopharyngeal Swab
1. Insert a wire-shafted or flexible plastic shaft nasopharyngeal swab through the nose into the nasopharynx and gently rotate.
42
2. Allow a few seconds for the swab to absorb the secretions.
3. Remove the swab and place into M4 transport medium, cut off wire with scissors and cap. Refrigerate.
Stool
1. Collect specimen in clean, dry container.
2. Transfer sufficient stool to M4 tube to make a 20–40% suspension in M4 transport medium. Refrigerate.
Stool Specimens for Rotavirus
• Specimens should be collected as soon after the onset
of symptoms as possible.
• Peak viral counts are reported to occur on days 3–5 after onset of symptoms. Samples collected 8 days or more after onset of symptoms may not contain enough rotavirus antigen to produce a positive reaction
• Collect 2 grams fresh stool (minimum 1 gram) in a clean container without media, preservatives, animal serum or detergents, as any of these may interfere with the test.
• Submit the specimen frozen. If stored for more than three days before arrival at the laboratory, freeze at –20°C or colder. Avoid thawing. Do not use self defrosting freezers.
Rectal Swab
Rectal Stool
1. Insert rayon, Dacron® or flocked nylon swab(s) at least three (3) centimeters into anal orifice; rotate to help ensure sufficient stool specimen on swab.
2. Break the swab tip(s) into M4 transport medium. Refrigerate.
Rectal Mucosa
1. Insert swab 4–6 centimeters into rectum and roll swab against the mucosa. Examine the swab to help ensure that fecal material is not present.
2. Break swab tip(s) off into M4 transport medium.
Refrigerate.
Respiratory aspirate or Washings
1. The quantity and quality of respiratory specimens to be tested can be improved by aspiration.
2. Collect aspirates from the nose, nasopharynx and oropharynx.
3. Aspirates may be collected using a number 5–8 disposable infant feeding tube attached to a 10 mL syringe or large suction bulb. If material cannot be aspirated, instill up to 5 mL of saline into the nasal passages and re-aspirate to collect washings.
4. As an alternative, use a suction catheter with a mucus trap.
5. Transfer up to 2 mL of aspirate to the M4 transport medium. Refrigerate.
Throat Swab
1. Vigorously swab tonsillar area and posterior orophar ynx using a rayon, Dacron® or flocked nylon swab.
2. Break swab tip(s) off into M4 transport medium. Refrigerate.
Urethral Swab
1. Insert mini-tipped swab at least 2 cm into urethral orifice. Rotate gently to obtain epithelial cells.
2. Break swab tip(s) off into M4 transport medium. Refrigerate.
Urine
1. Obtain a fresh, clean-catch specimen in a clean container.
2. Transfer 3 mL of urine to M4 transport medium. Refrigerate.
3. If less than 1 mL of urine is available, submit urine without transport medium in a sterile, leak-proof container. Refrigerate.
Virus specific cultures using rapid
methods
Herpes Simplex Virus (HSV) Culture
The specimen will only be examined for the presence of
herpes simplex virus. HSV can be isolated by conventional tissue culture methods (as part of an anatomic
specific virus culture) or by rapid culture techniques
(ELVIS® test). With the ELVIS® technique, the specimen
is centrifuged onto genetically engineered cells. After
16–20 hours of incubation, a colorless substrate is added
to the cells. If the cells are infected with HSV, the enzyme
galactosidase is induced and accumulates. This enzyme
reacts with substrate and turns the cells blue. If typing is
also requested, HSV-positive cultures are stained with
fluorescein-conjugated monoclonal antibodies that
differentiate HSV-1 from HSV-2.
Rapid Viral Respiratory Culture Screen with
Reflex
Nasopharyngeal lavage/wash, nasal swab or throat swab
(adult) specimens are preferred. They should be placed
in M4 transport medium (blue cap) or equivalent and
transported to the laboratory at 2–8° C. Use only Dacron®, rayon, or flocked nylon tipped plastic shaft
swabs for specimen collection. Specimens will be examined for the presence of Influenza A and B, Parainfluenza
1,2 and 3, adenovirus and RSV by rapid shell vial technique. The rapid shell vial method is performed by
centrifuging the specimen onto susceptible cells. Approximately 48 hours after inoculation, cells are
stained with a fluorescein-conjugated monoclonal
antibody pool of seven respiratory viruses. If this screen
is positive, the cells will then be stained with the specific
monoclonal antibodies for Influenza A and Influenza B,
Parainfluenza 1,2 and 3, adenovirus and Respiratory
Syncytial Virus (RSV).
43
Specimens for Viral Nucleic Acid
Detection
Human Papillomavirus DNA (HPV)
HPV DNA can be detected in specimens collected
on ervical brush, in fresh biopsy tissue and liquid Pap
test medium.
Cervical Biopsies
Freshly collected cervical biopsies (2-5 mm in crosssection) may also be analyzed. The biopsy specimen
must be placed immediately into 1 mL of Digene®
Specimen Transport Medium and stored frozen at
–20°C (or lower). Transport to the laboratory frozen.
Human Immunodeficiency Virus (HIV) RNA
See the following tests in the Test Application and Interpretation section:
•
•
•
HIV Infection Markers for Diagnosis and Monitoring Therapy
HIV-1 DNA, Quantitative HIV-1 RNA Assay
HIV-1 Genotype
Hepatitis A, B and C Virus Nucleic Acid
See the following tests in the Test Application and Interpretation section.
•
•
•
44
Molecular Testing in the Management of Hepatitis C Virus Infection
Hepatitis C Viral RNA, Quantitative
Hepatitis C Viral RNA Genotype, LiPA®
Serology
Most acute infections elicit an immune response.
There are some important exceptions, however:
1.
2.
3.
Some superficial infections may fail to induce an antibody response despite significant illness.
Infections in immunocompromised individuals, including certain healthy young infants, may not result in a significant antibody response.
Acute infections and immunizations may be thwarted, in the presence of passively acquired antibody, circumventing the production of new patient antibody; e.g., trans-placental IgG anti
body may prevent the production of antibody to the measles vaccine if administered to infants too early. Antibodies of the IgM class usually appear early in the infection, prior to the appear
ance of the IgG class. The presence of IgM anibody is usually transient and is suggestive of a current or recent, not necessarily a primary, infection. Recurrent or reactivated infections have been known, on occasion, to elicit an IgM response especially among the herpes virus group (CMV, HSV, EBV). IgM antibody usually appears 7-10 days after a primary infection and reaches maximum levels within 2-3 weeks. The duration of the IgM response is variable, dependent upon the infecting organism and the patient. Therefore, interpretation of a positive IgM test result must be made with caution and in conjunction with clinical findings. IgG antibody usually appears after the initial IgM response and reaches peak levels 3-4 weeks later. IgG antibody may persist for life; individuals who have a mild infec
tion or are treated early in the course of the
disease may revert to an apparent negative IgG status over time. The detection of IgG antibody suggests past exposure, infection or immunization to the organism. With many diseases, (e.g., rubella, measles, etc.), in the absence of a current or recent infection, the presence of IgG is consistent with immunity to the disease. Antibody/serology tests are designed to detect either multiple or specific classes of immunoglobulins, e.g., total antibody versus specific IgG or IgM.
Serum
Collect blood in a red-top or serum separator tube
(SST®) and process according to instructions in the
Blood, Urine and Stool section.
Cerebrospinal Fluid (CSF)
• CSF will be accepted only for serologic testing for certain organisms that are associated with neuro-
logical diseases. See General Test Listing in this Guide.
• Collect blood-free CSF as directed in the Specimen Collection and Handling section of this Guide.
• Refrigerate the CSF (at 4° C) until it is transported
to the laboratory.
• A serum sample, collected at the same time as the CSF is often necessary for serologic diagnosis of central nervous system diseases.
Other Body Fluids
Body fluids other than serum and CSF are not generally
acceptable for serological testing.
45
Cytology
Gynecologic cytology and HPV testing is available.
HPV testing can be optionally ordered as a reflex to
Atypical Squamous Cells (ASC) in women under the
age of 30, or in conjunction with the Pap in women
over 30. Our reports use standard descriptive Cytopathology terminology (Bethesda 2001) which
includes feedback on sample adequacy. Gynecologic
cytology is a screening test which is subject to both
false positive and false negative results. For that
reason, the test is most reliable when a satisfactory
sample is obtained on a regular, repetitive basis.
Hence, these results must be interpreted in the context of historic and current clinical information.
General Submission Requirements
Specimen Identification
We cannot accept specimens that are improperly
labeled.
• Label all slides on frosted end in pencil with patient’s first initial and full last name or unique identifier.
• Label specimen containers (on the container wall, not the lid) with the patient’s first initial and full last name or unique identifier and site(s) of specimen collected.
• Unacceptable specimens will be rejected.
Unacceptable Specimens
•
•
•
•
•
•
•
•
•
46
No patient identification on test requisition
Illegible or no patient identification on the slide or specimen container. Labeling the slide holder only is not adequate identification.
No account/physician number or name
Slides broken beyond repair
Leakage of sample during transport
Mismatch between name of patient on specimen and name on test requisition
No source indicated on test requisition for non-
Gyn specimens
Expired liquid-based preservative/vial
Syringes are not acceptable specimen containers.
Gynecologic Specimens: The “Pap”
Test (By Liquid Based Cytology & Conventional PAP smear)
Ordering Information
Complete a Cytopathology test requisition including:
•
•
•
•
•
•
•
•
Patient’s full name (any name change in the past 5 years should be noted) and/or unique identifier
Date of birth
Source of specimen (cervical, endocervical, vaginal, or other gynecologic or non-gynecologic site)
Submitting physician’s name and account information
Last Menstrual Period (LMP)
Menstrual status (hysterectomy, pregnant, postpar
tum, menopause, hormone therapy)
Previous abnormal cervical cytology results, previous treatment, biopsy or surgical procedure
Other pertinent clinical information
Patient Preparation
1. Schedule an appointment approximately two weeks (10–18 days) after the first day of last menstrual period. Menses may interfere with Pap test interpretation.
2. No use of douche for 48 hours prior to the test.
3. No use of tampons, birth control foams, jellies/
lubricants or other vaginal creams or vaginal medica
tions for 48 hours prior to the test.
4. Refrain from intercourse 48 hours prior to the test.
5. The clinician should not use any lubricant jelly for the examination until after the Pap has been obtained
6. Testing for Human Papilloma Virus (HPV) DNA is an important adjunct to the diagnosis of pre-malignant or malignant lesions, and it can be performed on the same liquid medium used to submit cytology samples.
Pap Specimen Collection and Handling
Liquid transport media are preferred for gynecological
cytology specimens. One such system available is the
ThinPrep® Pap Test.
ThinPrep® Pap Test
Broom-Like Device
1. Complete the Cyto/Tissue or Ob-Gyn requisition.
2. Record the patient’s first initial and full last name or unique identifier on the vial.
3. Obtain an adequate sampling from the cervix using a broomlike device. Insert the central bristles of the broom into the endo cervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clockwise direction five times.
4. Rinse the broom in the PreservCyt® Solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. Swirl the broom vigorously to further release material. If material is still visible on the bristles,
then scrape the bristles against the vial staying within the fluid. Swirl the broom vigorously to further release material. Discard the collection device. Do not let the broom sit in the vial.
5. Tighten the cap so that the torque line on the cap passes the torque line on the vial.
6. Place the vial and requisition in a specimen bag for transport to the laboratory.
Note: ThinPrep® sample stability at 37oC is for 6 weeks for cytology. Reprocess samples some-
times required for bloody specimens to precure adequates cellulerity, not suitable for HTV DNA testing.
SurePath® Pap Test
Broom-Like Device (Rover’s Cervex-Brush®)
1. Complete the Cyto/Tissue or Ob-Gyn requisition.
2. Record the patient’s first initial and full last name or unique identifier on the vial. Ensure ThinPrep vial contains PreservCyt® solution upto marked/
specified level.
3. Obtain an adequate sampling from the cervix
using a broomlike device. Alternatively, cytobrush & spatula can be used in patient where endocer-
vex not accessible by cervex brush.
4. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clockwise direction five times. DO NOT ROTATE IN A COUNTERCLOCKWISE DIRECTION.
5. Remember - The pressure applied to cervix through brush while sampling should amount no more than the pencil pressure applied while writting on a piece of paper.
6. Rinse the cervex-brush into the ThinPrep® vial using a vigorous swirling motion. At ate the brush forcefully
at least 10 times against the bottom of the container, check brush to ensure that no material is clinging on to the brush.
7. Tighten the cap so the torque line on the cap passes the torque line on the vial.
8. Place the vial and requisition in a specimen bag for transport to the laboratory.
Conventional Pap Test
1. Complete the test requisition.
2. Using a lead pencil, write the patient’s first initial and full last name or unique identifier on the frosted end of the slide. Unlabeled slides cannot be accepted.
3. Insert the extended tip of the spatula in the endo
cervical canal and rotate allowing blunt edge of spatula to scrape the ectocervix. Do not smear yet.
4. Insert the Cytobrush® into the endocervical canal until the bristles are barely visible. Turn 90°–180° and remove. Brush is not recommended for use during pregnancy.
5. Smear the extended tip spatula (cervical) specimen along the entire length of the slide using only half of the surface.
6. Roll the Cytobrush® (endocervical) specimen along the entire length of the slide using the remaining half of the slide surface. Bending the bristles will help transfer the cells to the slide.
7. IMMEDIATELY APPLY FIXATIVE. Ideally, immerse in a coplin jar containing absolute alcohol (Ethyl alcohol). If using spray fixative, hold the dispenser 6–10” from the slide. DO NOT use commercial hair spray as a fixative. The variability of ingredients results in poor specimen preservation.
8. Allow to dry completely before closing the slide holder.
47
Non-Gynecologic Specimens
Fluid/Washings/FNA fluids
Ordering Information
Submit the fluid fixed with a minimum of 10 mL of
fixative. Specimens larger than 10 mL should be fixed
with a volume of fixative equal to the volume of the
specimen.
Complete a Cytopathology test requisition including:
• Patient’s full first and last name (any name change in the past 5 years should be noted), unique identifier and date of birth
• Date of birth
• Submitting physician’s name, telephone number and account information
• Source and specific anatomic site, e.g., body site, left, right, and quadrant, etc.
• Collection method, e.g., Washing, Brushing and FNA, Fluid
• Nature of lesion, e.g., solid/cystic, mobile/fixed, and functional/nonfunctional
• Any other pertinent history, e.g., previous surgery, presence of other masses, and previous abnormal findings
• Mammography, X-ray or other imaging findings
• Diagrams of the site sampled may be helpful, especially for fine needle aspiration biopsies
Specimen Collection and Handling
Smear
(NOTE: Cyst contents should be submitted as fluids
and not smears.)
1. Write patient’s first initial and full last name or unique identifier in pencil on the frosted end of slide.
2. Submit slide(s), Ideally 3-5, of material from any source that can be evaluated cytologically.
3. Allow 1/2 prepared slides for air drying.
4. Fix slides immediately with cytology spray fixative or immerse in ethyl alcohol for 3–5 minutes.
5. Allow the fixative to dry thoroughly before pack-
aging slides for transport.
6. Submit in an appropriate slide container at room temperature.
48
Note: Stability or Unfix and refrigerated cytology fluid
sample in only 24 hrs.
Appropriate Fixatives for Non-Gyn Cytology
Specimens
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
CytoLyt® Solution
Saccomanno fixative (Carbowax™)
Ethyl alcohol
Isopropyl or methyl alcohol may be used as a substitute if none of the above three fixatives are available. Place fluid/fixative mixture in a tightly capped, leakproof, labeled container (label the container wall, not the lid). The following specimens are prepared by mixing the material with an equal volume of fixative.
Breast Cyst Aspiration
Effusion (Ascites, Peritoneal or Pericardial fluid, Synovial fluid)
Bronchial Washings/Lavages (BAL)
Endometrial Washings
Esophageal Washings
Gastric Washings
Paracentesis (Abdominal) Fluid
Pericardial Fluid
Thoracentesis (Pleural or chest) Fluid
Sputum
FNA fluid
Pus Aspirate Cytology
Urine
Brushings
Roll brush(es) over clean, dry slide(s). Make 1 or 2 air
dried smear and fix rest of the smears immediately with
absolute alcohol or spray fixative. The brush(es) used to
prepare bronchial washing slides may be swirled in a
container of appropriate fixative to dislodge additional
specimen. Submit slides and liquid specimen together
with one test requisition.
Breast secretion
(Nipple Discharge)
Drops of fluid from the nipple are smeared directly
onto clean glass slides and fixed immediately by
immersing in absolute alcohol for 3-5 minutes or
alternatively by spray fixative.
Slide FNA technique for any solid
mass aspiration
1. Label glass slide(s) with the patient’s first initial and full last name or unique identifier on the frosted end prior to starting the procedure.
2. If local anesthetic is used, insert the anesthetic needle adjacent to, but not into, the lesion. The anesthetic could dilute or distort the specimen and hinder achieving an accurate diagnosis.
3. Attach a 23 or 25 gauge needle to a syringe.
4. Insert needle into lesion.
5. While applying negative pressure, move needle back and forth traversing the entire lesion.
6. Release negative pressure, then remove needle. Specimen should not be drawn up into the barrel of the syringe. Pressure should be released as fluid appears in the needle hub. The cells and tissue fragments obtained from a solid lesion should remain in the barrel of the needle.
7. After withdrawing the needle, eject one drop of specimen onto each of 2–3 slides. Label one “Airdried” slide as such if applicable.
8. Use another slide to evenly smear the aspirated material.
9. Fix slides immediately (within a few seconds) using cytology spray fixative or immerse in alcohol for 3–5 minutes.
10.Do not fix slide(s) labeled “air dried.”
11. If blood, fluid or cellular material in excess of three
drops is obtained with a needle pass, the excess should be expressed into a container of CytoLyt® or other cytology fixative.
12.Flush needle and syringe with this same fixative.
13.This procedure can be repeated multiple times, using sterile syringe and needle each time, until the lesion has been thoroughly or adequately sampled.
14.Submit the liquid specimen together with the fixed and air-dried slides using one test requisition.
Skin (Viral) Lesion: Tzanck Smear
Remove crust or dome from lesion. Scrape ulceration
with a curette. Spread material on alcohol-moistened
slide. Fix slides immediately (within a few seconds) using cytology spray fixative or immerse in alcohol
fixative for 3–5 minutes. Make 1 “Air Dried” slide and
label accordingly.
Sputum
Submit early morning deep-cough specimen prior to any
food ingestion. Have patient rinse mouth with plain water
before sputum is collected. Collect separate specimens
on 3 consecutive mornings. Do not pool the specimens.
Mix material with an equal volume of fixative (for fixatives, refer section ‘Appropriate fixatives for non-gyn
cytology specimens).
Urine
Instructions for Urine Collected in the Office (Voided or Catheterized)
Submit all specimens in an equal volume of fixative (See
Appropriate Fixatives for Non-Gyn Cytology Specimens
in the Cytology section). Mark test requisition “Voided”
or “Catheterized” as applicable. For offices with centrifugation capability, see steps 2 and 3 in the Urine Collected
When a Centrifuge is Available (below).
Patient Instructions for Urine Collected at Home
1. Provide patient with an appropriate volume of fixative (e.g., 50 mL of alcohol or pre-measured container of CytoLyt®).
2. Instruct the patient to drink three (3) 8-oz. glasses of water before bedtime.
3. Instruct the patient to discard the first morning void and collect the specimen from the second morning void. Mix an equal volume with the fixative. Do not submit a 24-hour urine collection for cytologic evaluation.
49
Instructions for Urine Collection When a Centrifuge is Available
1. Instruct the patient to void into clean specimen container. A sterile container is not necessary; however, if that is the only container available, it may be used.
2. Mix the specimen by gently swirling in the container.
3. Immediately fill two (2) 15 mL conical tubes and centrifuge at 400 RCF for 10 minutes. The centri-
fuge speed and time may be adjusted to conform to procedures used for routine urinalysis.
4. Carefully decant the supernate after centrifuging and transfer the cell sediment from the bottom of each tube into appropriate fixative in a leak-proof container. See Appropriate Fixatives for Non-Gyn Cytology Specimens in the Cytology section.
5. If for some reason centrifugation is not possible, voided urine may be added directly to the appro-
priate fixative. Please do not add more than 20 mL of a wellmixed specimen.
Lymph Node (Touch Prep)
Label one or two “Air-dried” slide. Fix remaining
slide(s) immediately in alcohol or use spray fixative.
50
Hematopathology
Hematopathology services are available through
Quest Diagnostics. Please feel free to contact our
pathologists for further information. The essence of
a successful Hematopathology program depends on
both the referring physician and the laboratory. A
pertinent clinical history and an adequate, properly
fixed, specimen are essential for correct diagnosis.
Specimen Handling and Ordering
Information
Bone Marrow
1. Label ALL containers and ALL bone marrow and peripheral smears with the patient’s first and full last name and date collected.
2. Submit at least one peripheral blood smear.
3. Submit at least 4 bone marrow smears and, if obtained, 2 touch imprint slides. Smears and touch imprint slides should be submitted in tightly wrapped plastic containers, bags, and/
or cardboard holders. Always separate them from formalin-fixed specimens. Unstained smears ex
posed to the slightest trace of formalin vapor will not stain properly.
4. Submit the bone marrow clot in formalin. Make sure the clot has formed before putting it in formalin. Label as “clot” and add left or right, if applicable.
5. Submit the bone marrow core in formalin. Label as “core” and add left or right, if applicable.
6. For flow cytometry, submit 3 mL of bone marrow aspirate or peripheral blood in an EDTA (lavender
top) or heparin (green-top) tube.
7. For chromosome analysis, submit 3 mL of bone marrow aspirate or peripheral blood in an EDTA (lavender-top) tube.
8. For molecular studies, submit 1 mL of bone aspirate or peripheral blood in an EDTA (lavender-
top) tube.
Ordering Information
Complete a Hematopathology test requisition including:
•
•
•
•
•
•
•
Patient’s full name
Date of birth
Source of specimen
Submitting physician’s name, telephone number and account information
Source of specimen
Clinical history
Most recent CBC result
Tissue biopsy and consultative pathology services are
available.
51
Tissue pathology
Specimen Handling and Ordering
Information
Routine Tissue Pathology
1. Obtain biopsy(ies) with care not to crush the specimen with forceps, hemostats, or other instruments. Cautery will cause heat artifact.
2. After biopsy, immediately place each specimen in a tightly secured container with 10% neutral buffered formalin. Do not force a large specimen into a small container; formalin must surround the specimen for proper fixation. Formalin volume to specimen ratio should be 10:1.
3. Use a separate container for each separately identified specimen.
4. Label each container wall (not the lid) with patient’s last name and first initial or unique identifier and source of specimen. Place one of the peel-off labels from the test requisition onto each specimen con tainer, if available. All biopsy containers should bear label mentioning Formalin as health hazard.
5. Do NOT freeze formalin-fixed specimens.
6. Complete a test requisition and send with patient’s specimen(s). Each container and specimen must be separately identified on the test requisition. The test requisition should reflect pertinent clinical information including patient’s date of birth, gender, clinical/pre-opdiagnosis (duration, size, impression), pertinent clinical history/operative findings and/or previous surgery, specific anatomic location of tissue
removed and the procedure (excision, cone, punch, etc.).
7. For any bone lesions (tumor or non-tumorous), preoperative radiograph is a must.
Paraffin Blocks for Molecular Pathology
and Cytogenetics
(Solid Tumors For ER/PR, DNA Ploidy, Flow Cytometry or Digital Image Analysis)
Estrogen and progesterone receptor (ER/PR) detection is available by immunohistochemical staining
52
and semiquantification by Digital Image Analysis. See
General Test Listing of this Guide. Submit a formalinfixed, paraffin-embedded tissue block, one routinely
stained (hematoxylin and eosin) histologic section of the block submitted, and appropriate clinical history.
Routine histology processing is preferred:
•
•
•
Decalcifying procedures may affect DNA results.
Certain formalin or xylene substitutes may adversely affect ER/PR staining results.
Tissues with freezing or crush artifacts should be avoided if possible.
DNA ploidy determinations on paraffin-embedded tissues by both flow cytometry and digital image analysis
are available. A histologic section of the submitted tissue
block is evaluated by a pathologist to determine what
may adversely affect ER/PR staining results.
Extent of Examination, Special Stains
and Other Techniques
The extent of tissue examination can be determined only
during the pathologist’s examination of the specimen.
Multiple sections, special stains, etc., may be needed.
Special stains and immunohistochemistry studies are
done at the discretion of the pathologist. Additional
charges will be incurred.
Fees
The fee for histopathology services will vary depending
upon the number of specimens submitted, the size and
complexity of the specimen and the necessity for additional tests. If you have any questions, please contact us
directly
Notes
53
54
55
56
57
58
Test Requisition
Information
59
60
Test requisition information
The Test Requisition is the critical document that
defines the tests ordered, for whom, and who and
how to contact with the results or additional information. Please complete legibly with a black
ballpoint pen. The easier the information is to read,
the less likely we will misenter the information.
Requisition Number
Each requisition has a unique identifier that is used
by the laboratory to identify all transactions with
the specimen. Customers can use this number
when asking about the status of the associated
specimen(s).
• Critical values (potentially imminently life threaten-
ing) will be called back as soon as the result is verified – regardless of the hour of the day.
Billing Information
These fields are used to indicate who is the responsible
party, and, if appropriate, the amount paid and receipt
number.
Information to Laboratory
At times, you may want to provide the laboratory with
specific information. This will be read by the laboratory
and not included on the medical report.
Patient Demographics
Clinical Information
The top left hand box provides fields to identify the
patient including contact information. For minors
or individuals with guardians, please indicate the appropriate individual for contact. The age (date
of birth and gender are used to supply appropriate
reference ranges for selected tests.
This information is useful in understanding how to
interpret results. At times, when the clinical information
provided here is inconsistent with laboratory results, the
laboratory will initiate an investigation as to the cause of
the apparent discrepancy. We appreciate understanding
the context in which laboratory tests are ordered. This
information is most essential when interpreting tissue
specimens.
Client Demographics
This box provides fields to identify the customer and
means of contact. Use of the client account number
simplifies this process.
Specimen Characteristics
• It is important to know if the patient is fasting for interpretation of selected tests.
• Fields are provided to indicate when the specimen(s) was(were) collected.
• Fields are available to list the volume and length of a timed urine collection, e.g., 24 hours.
• Identification of the collection site assures the medical report will be available, as may be requested.
• Identification of the individual who collected the specimen is helpful if there is need for additional information and for purposes of quality assurance.
Gyn Cytology
In addition to listing the most commonly ordered tests,
fields are available to provide clinical information. This is
useful for accurate interpretation of the specimen.
Health Panels
Our physicians developed these health panels to address
the most common medical conditions. Additional panels of tests can be developed based on your needs and
preferences.
Individual Tests
These represent commonly ordered tests especially for
cardiovascular disease, diabetes, chronic kidney disease,
breast cancer, and other common conditions.
Report Delivery
• Reports can be sent to the patient only, physician/
hospital only, or both. We offer multiple means of report delivery.
61
Contact Information
Contact information is listed for your convenience.
Peel-off Labels
Peel-off labels are provided to link the requisition
with the specimen(s). Occasionally, handwritten labels are completed or are adhered to the specimens
later and incorrectly. The peel-off labels provide an
important quality measure to reduce specimen mixup. In addition to the pre-labeled requisition number,
each label should be labeled with the patient’s full
name. Additional information such as date and initials of the individual who collected the specimen(s) is often squeezed onto the label as well.
Specimen Requirements
This box on the reverse side describes the key next to
each test as to the specimen type and the specimen
tube or container.
Feedback
Quest Diagnostics believes we improve when we
hear from you (the Voice of the Customer). We
will actively solicit your input in surveys. However,
feedback is always welcomed (positive and not so
positive).
Please contact us and we will respond to meet your
needs and those of your patients.Thank you for your
trust in Quest Diagnostics. The dedicated employees
of Quest Diagnostics work hard everyday to earn it.
Together, we hope to bring new insights that improve
the lives of patients.
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General Test Listing
63
64
A1c
A
B
See “Hemoglobin A1c”
A2 Quantitation, Hemoglobin Variant, Thalassemia
See “Hemoglobinopathy Evaluation”
ABL Kinase Domain Mutation in CML, Plasma-Based, LeumetaTM Preferred Specimen(s) Instructions
Transport Container
Transport Temperature
Methodology
Clinical Significance
3 mL whole blood collected in EDTA (lavender-top) tube
Information regarding draw time and date is required to ensure stability of the sample is maintained. Submission of whole blood is preferred. To avoid contamination, the laboratory will separate the plasma upon arrival. Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in an EDTA tube. Blood samples are shipped at room temperature or 4°C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability. Submission of plasma is acceptable. Collect blood in sterile tubes containing EDTA (lavender-top). Separate plasma from the cells by centrifugation, transfer the plasma to a separate plastic screw-cap vial, and ship frozen.
EDTA (Lavender top) tube
Whole blood: Refrigerated (cold packs), stable 72 hours
Plasma: Frozen
Reverse Transcriptase Polymerase Chain Reaction (RTPCR) • Nested PCR • Sequencing
Chronic myelogeneous leukemia (CML) is a hematopoietic stem cell disorder, the result of a (9:22) translocation that produces the constitutively active, BCR-ABL tyrosine kinase. Mutations within the BCR-ABL kinase domain are the most commonly identified mechanism associated with relapse. Specific amino acid substitutions lead to drug resistance.
ABO Group and Rh Type (Blood Grouping) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
4503
Sputum( Three consecutive morning samples are preferered; Random samples are also acceptable), Gastric lavage ( Patient should be fasting for previous 12 hours), BAL, Tracheal secretion, urine, Pus, Body fluids,tissue, Bone marrow in heparinised tubes, stool
Slide carrier or sterile plastic screw-cap container with sample type labeled
Slide at Room Temperature & other specimens refrigerated
Raw specimens greater than 5 days old • Pooled specimens • Blood in EDTA (lavender-top) tube • Specimens in formalin
Decontamination and concentration as needed and microscopic examination by fluorochrome stain (auramine rhodamine)
Positive smears indicate the presence of acid fast organisms
Acid Fast Stain - Kinyoun Method Preferred Specimen(s)
Transport Container Transport Temperature
7788
3mL whole blood collected in a EDTA (lavender-top) tube or ACD-A or ACD-B (yellow-top) tube. If submitted with a CBC, HbA1c or any other test requiring a EDTA (lavendertop) tube, submit a separate tube for this test.
EDTA (lavender-top) tube or ACD-A or ACD-B (yellow-top) tube
Room temperature, Stable 6 Days
Hemolysis • Received frozen • Serum Separator Tube (SST®)
Immune Agglutination
ABO type and Rh are needed to identify candidates for Rh immune globulin and to assess the risk of hemolytic disease of the newborn
Acid Fast Stain - Flurochrome Method Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
16031
14511
Sputum (Three consecutive morning samples are preferered;Random samples are also acceptable), Gastric lavage ( Patient should be fasting for previous 12 hours), BAL, Tracheal secretion,urine, Pus , Body fluids,tissue,Bone marrow in heparinised tubes, stool
Slide carrier or sterile plastic screw-cap container with sample type labeled
Slide at Room Temperature & other specimens refrigerated
65
A
B
Reject Criteria
Methodology
Clinical Significance
Raw specimens greater than 5 days old • Pooled specimens • Blood in EDTA (lavender-top) tube • Specimens in formalin
Microscopic Examination
Positive smears indicate the presence of acid fast organisms
Acid Fast Stain, modified Stool Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
14512
5 grams (5 mL) stool. Transfer stool within 30 minutes of collection into formalin vial. Fill to the line on the transport vial.
10% formalin transport vial
Room temperature, stable 48 hours
Unpreserved stool • Frozen
Microscopic exam of modified acid fast stain
Cyclospora cayetanensis and Isospora belli are coccidian parasites which cause malaise, low grade fever, and diarrhea. Fatigue, anorexia, vomiting, myalgia and weight loss occur. The clinical presentation for those patients infected with either disease is similar.
ACTH
See “ACTH, Plasma”
Actin
See “Smooth Muscle Antibody (IgG)”
Activated Protein C-Resistance 22
Preferred Specimen(s)
2 mL plasma collected in a tube with 3.2% sodium citrate (light blue-top) Freeze immediately
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received room temperature • Received refrigerated
Methodology
RVVT Based Clot Assay
Clinical Significance
To screen for APC-R associated with venous thromboembolic disorders.
Acute Hepatitis Panel with Reflex
See “Hepatitis Panel, Acute with Reflex Confirmation”
Acid Fast Stain-Ziehl Neelsen Method Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Methodology
Clinical Significance
78649
Sputum (Three consecutive morning samples are preferered;Random samples are also acceptable), Gastric lavage ( Patient should be fasting for previous 12 hours), BAL, Tracheal secretion, urine, Pus, Body fluids, tissue, Bone marrow in heparinised tubes, stool
Specimens of gastric aspirates should be neutralized with 1 gm of sodium carbonate per 15 mL of specimen before transport to the laboratory. Specimens should be delivered to the laboratory within one day of collection.
See Specimen Collection section for general sitespecific instructions.
Slide carrier or sterile plastic screw-cap container with sample type labeled
Slide at Room Temperature & other specimens refrigerated
Microscopic Examination
The Ziehl Neelsen method serves to confirm the acidfast nature of recovered organisms from solid media and from positive broth cultures detected by the MGIT 960.
ADA (Adenosine Deaminase)
79114
Preferred Specimen(s)
1.0 mL Serum, Heparinized plasma, Body fluids (Pleural fluid, Peritoneal fluid, CSF)
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, Stable for 7 days
MethodologySpectrophotometry
Clinical Significance
ADA is an enzyme catalyzing the deamination reaction from adenosine to inosine. The enzyme is widely distributed in human tissues, especially high in T Iymphocytes. 66
Elevated serum ADA activity has been observed in patients with acute hepatitis, alcoholic hepatic fibrosis, chronic active hepatitis, liver cirrhosis, viral hepatitis and hepatoma. Increased ADA activity was also observed in patients with tuberculous effusions. Deamination of ADA activity in patient serum may add unique values to the diagnosis of liver diseases in combination with ALT or gamma-GT (GGT) tests. ADA assay may also be useful in the diagnosis of tuberculosis.
AFP
See “Alpha-Fetoprotein, Tumor Marker”
AFP Quad Screen
See “Maternal Serum Screen 4”
Alanine Amino Transferase (ALT) / (SGPT) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Alanine Aminotransferase (ALT) measurements are useful in the diagnosis and treatment of heart disease and certain liver diseases, e.g., viral hepatitis and cirrhosis. ALT activity in tissue is generally much lower than aspartate aminotransferase (AST) activity and is found in highest concentrations in the liver. Significant elevations of ALT occur only in diseases of the liver. ALT is often measured in conjunction with AST to determine whether the source of the AST is the liver or the heart. ALT is normally not elevated in cases of myocardial infarction, i.e., a normal ALT, in conjunction with an elevated AST, tends to suggest cardiac disease. However, slight elevations of ALT may occur if an infarct destroys a very large volume of heart muscle.
Albumin Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
823
223
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Anticoagulants other than heparin • Hemolysis
Spectrophotometry (SP)
Serum albumin measurements are used in the monitoring and treatment of numerous diseases involving primarily the liver and kidney. Its main value lies in the follow-up therapy where improvement in the serum albumin level is the best sign of successful medical treatment. There may also be a loss of albumin in the gastrointestinal tract, in the urine by the damaged kidney or direct loss of albumin through the skin. More than 50% of patients with gluten enteropathy have depressed albumin. The only cause of increased albumin is dehydration; there is no naturally occurring hyperalbuminemia.
Alcohol, Ethyl Qualitative, Urine (Ethanol) 78094
Preferred Specimen(s)
10 mL random urine
Transport Container
Plastic urine container
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
Urine with preservative
MethodologyImmunoassay
Clinical Significance
Ethanol is the most often abused chemical substance. Other CNS depressant drugs have an additive effect when taken in combination with ethanol. Ethyl alcohol is present in many medicinal liquids and mouthwashes.
67
A
B
A
B
Alkaline Phosphatase Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Serum alkaline phosphatase levels are of interest in the diagnosis of hepatobiliary disorders and bone disease associated with increased osteoblastic activity. Moderate elevations of alkaline phosphatase may be seen in several conditions that do not involve the liver or bone. Among these are Hodgkin’s disease, congestive heart failure, ulcerative colitis, regional enteritis, and intra-abdominal bacterial infections. Elevations are also bserved during the third trimester of pregnancy.
Alpha-1- Antitrypsin Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
235
1.0 mL Serum
Plastic Screw cap vial
Refrigerated, stable 7 days
Gross Hemolysis
Nephelometry
Alpha-1-Antitrypsin level may be increased in normal pregnancy and in several diseases including chronic pulmonary disease; hereditary angieoedma; renal, gastric, liver and pancreatic disease; diabetes, carcinomas and rheumatoid diseases. Alpha-1-Antitrypsin may
be decreased in emphysema, hepatic cirrhosis, respiratory distress syndrome of newborn, nephrosis, malnutrition and cachexia.
Alpha-1 Antitrypsin (AAT) Mutation Analysis, Genotype Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
234
15340
5 mL whole blood collected in EDTA (lavender-top) tube
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
EDTA (lavender-top) tube
Whole blood: Room temperature, stable 8 days Serum: Refrigerated stable 7 days
Moderate or gross hemolysis • Received refrigerated • Whole blood received frozen • Serum received room temperature
Fluorescent Restriction Fragment Length Polymorphism
Individuals who carry two copies (homozygous) for the Z allele are at a higher risk to develop liver disease and emphysema.
Alpha-Fetoprotein, Maternal Serum
See “Maternal Serum Screen 3”
See “Maternal Serum Screen 4”
See “Maternal Serum Screen 5”
Alpha-Fetoprotein, Tumor Marker 237
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Stable 1 week, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Hyperlipemic • EDTA or heparinized plasma
MethodologyChemiluminescence
Clinical Significance
Elevation of serum AFP above values found in healthy individuals occurs in several malignant diseases, most notably nonseminomatous testicular cancer and primary hepatocellular carcinoma. AFP is not recommended as a screening procedure to detect cancer in the general population.
ALT
See “Alanine Aminotransferase (ALT)”
68
AML1-ETO t(8;21) RT PCR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79560
3 mL Whole blood (EDTA)
Do not freeze. Record the draw time and date on the tube. Information regarding draw time and date is required to ensure stability of the sample is maintained. Ship immediately to maintain sample stability.
EDTA (lavender-top)
Refrigerated acceptable 72 hrs
Received Frozen
Real-Time Reverse Transcriptase Polymerase Chain Reaction
This assay is a real-time quantitative RT-PCR assay. Extracted sample RNA is subjected to two tubes realtime RT-PCR reaction to measure the quantity of the fused mRNA and the mRNA of an internal control. The results are reported as a ratio between the quantity of
the fused mRNA to the internal control mRNA. In general, a normal person does not have any fused mRNA and the report will show ‘ ‘negative’ ‘ without any number. The positive sample will report the ratio. The analytical sensitivity of this test is 1 tumor cell in 100,000 normal cells. The mRNA transcripts of samples produced by the tumor cells vary widely from patient to patient, making it difficult to compare the quantitative results between patients. The quantitative results should only be used to monitor the patient’s own tumor load sequentially.
Amoeba
See “Entamoeba histolytica Antibody, IgG, EIA”
Amphetamine Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78080
5.0 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay, Spectrophotometry
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Amylase serum 243
Preferred Specimen(s)
1 mL serum
Transport Container
Red-top tube, serum separator tube (SST®), plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 3 weeks
Reject Criteria
Hemolysis • Lipemia
MethodologySpectrophotometry
Clinical Significance
The major sources of amylase are the pancreas and the salivary glands. The most common cause of elevation of serum amylase is inflammation of the pancreas (pancreatitis). In acute pancreatitis, serum amylase begins to rise within 6-24 hours, remains elevated for a few days and returns to normal in 3-7 days. Other causes of elevated serum amylase are inflammation of salivary glands (mumps), biliary tract disease and bowel obstruction. Elevated serum amylase can also be seen with drugs (e.g., morphine) that constrict the pancreatic duct sphincter preventing excretion of amylase into the intestine.
Anemia Extended Profile (CBC, Reticulocyte Count, Folate Serum, Vitamin B12, Iron Total and Total Iron Binding Capacity)
78664
Preferred Specimen(s)
1.0 mL Serum, 2.0 mL Whole Blood collected in (lavender top) EDTA tube
Transport Container
Plastic screw cap vial
Transport TemperatureRefrigerated
Reject Criteria
Grossly hemolysed specimens are rejected
69
A
B
A
B
Mathodology
Clinical Significance
See individual analyte
See individual test for Clinical significance
Antifungal Susceptibility Panel Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
A Pure Culture yeast Isolate
Medium in tube or plate (e.g. SDA)
Isolates greater than 24 hours old should be subcultured prior to testing. Isolates may be stored at room temperature or refrigerated prior to subculture (1 week).
Contaminated specimen
Colorimetric Method
Fungi cause many types of infections, some of which may become serious, especially in immunocompromised and hospitalized patients. The appropriate collection, transport and processing of specimens are very important considerations in determining the etiology of fungal disease. The appropriate handling of specimens allows the recovery of fungal organisms and the association of a specific fungus with a disease process.
Antinuclear Antibody Screen (ANA), IFA Perferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79030
79005
1 mL serum
Plastic screw-cap vial
Ambient : Not defined, Refrigerated 7 days, -20oC Longterm
Gross hemolysis Hyperlipemic
Titer: Indirect Immunofluorescence (IFA)
This screening test with reflexive testing to the traditional IFA procedure is useful for the diagnosis of SLE and other autoimmune disorders. The descriptive IFA pattern may suggest a specific disease entity or autoantibodies.
Anti Thyriod proxidase (Anti-TPO) 5081
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plsatic screw cap vial
Transport Temperature
Refrigerated 2 days
Reject Criteria
Grossly hemolyzed specimen
MethodologyChemiluminescence
Clinical Significance
Thyroid peroxidase (TPO) is an enzyme that catalyzes the iodination and coupling steps in thyroid hormone biosynthesis. It is now known to be the principal microsomal antigen against which antibodies are directed in autoimmune thyroid diseases. The main use of this test is to confim that a patient’s diffuse goiter and/or hypothyroidism is due to autoimmune thyroiditis. The test may also help distinguish Graves disease from toxic nodular goiter. The TPO antibody
measurement has replaced the thyroid antimicrosomal antibody (AMA) measurement. TPO antibodies may be detected in individuals without clinically significant thyroid disease. They do not define the patient’s thyroid functional status.
Anti Thyroglobulin Panel 7260
Includes
Anti-TPO, Anti-TG
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plsatic screw cap vial
Transport Temperature
Refrigerated 2 days
Reject Criteria
Grossly hemolyzed specimen
MethodologyCLIA
Clinical Significance
Measurement of thyroglobulin antibodies is useful inthe diagnosis and management of a variety of thyroid disorders including Hashimoto’s thyroiditis, Grave’s disease and certain types of goiter.
ANCA
See “ANCA Vasculidites”
70
Androstenedione 78110
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic screw cap vial
Transport Temperature
Refrigerated 24 hrs
Reject Criteria
Grossly hemolyzed specimens are rejected
MethodologyChemiluminescence
Clinical Significance
Androstenedione may be useful in evaluating patients with androgen excess and managing patients with congenital adrenal hyperplasia (CAH).
Anemia Panel 1 78531
Includes
Complete Blood Count (CBC), Reticulocyte count.
Preferred Specimen(s)
Two 3 mL whole blood in EDTA (lavender-top) tubes
Transport Container
2 EDTA tubes
Transport TemperatureRefrigerated
Reject Criteria
EDTA with hemolysis or received frozen or clotted
Methodology
Electronic Cell Sizing, Sorting/Microscopy
Clinical Significance
See Individual test
Anemia Panel 2 78532
Includes
Complete Blood Count (CBC), Iron, TIBC, % Saturation (calculated), Reticulocyte count, Ferritin, Peripheral blood smear, Hemoglobin Electrophoresis
Preferred Specimen(s)
Two 3 mL whole blood in EDTA (lavender-top) tubes, 1.5 mL serum from a red-top tube
Transport Container
2 EDTA tubes, 1 red-top tube
Instruction
Transfer whole blood to a plastic shipping vial to prevent breakage. Repeated freezing and thawing (up to 10 times) does not affect the test result. Mix specimen thoroughly after thawing.
Transport Temperature
Room temperatureor Refrigerated
Reject Criteria
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic
Methodology
Electronic Cell Sizing, Sorting/Microscopy, Spectrophotometry, Electrophoresis, Sepctrophotometry
Clinical Significance
See Individual test
Anemia Panel 3 Includes
Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78534
Complete Blood Count (CBC), Vitamin B12, Folate, Intrinsic Factor Blocking Antibody, Reticulocyte count
Two 3 mL whole blood in EDTA (lavender-top) tubes, 1.5 mL serum from a red-top tube and 2 ml serum in no additive (red-top) tube (for B12)
Do not expose the serum specimen to light for more than 24 hours. Avoid freezing and thawing. (for Folate and B12 test). For Anti Intrinsic Factor Antibody test, Centrifuge cells, pour off, and transport serum on ice.
2 EDTA tubes; plastic screw-cap vial (frozen serum), No additive (red-top) tube
Room temperature
No additive (red-top) vial with 2 ml serum should be refrigerated, on cold pack
Frozen serum for Anti Intrinsic Factor Antibody test
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic
Chemiluminescence, Electronic Cell Sizing, Sorting/Microscopy, Immunoassay
See Individual test
Angiotensin-1-Converting Enzyme 683
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 1 week
Reject Criteria
Gross hemolysis
MethodologySpectrophotometry
Clinical Significance
Increased in sarcoidosis, Gaucher’s disease and lymphoangiomyomatosis
71
A
B
A
B
Ankylosing Spondylitis
See “HLA-B27 Antigen”
Antenatal Panel - I Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
19909
ABO group & Rh; CBC with Differential; Urinalysis, Complete; ALT, Albumin, Direct Bilirubin, Total Bilirubin, Total Cholesterol, Ferritin (if Iron:TIBC is < 0.15 or > 0.50), Calculated Globulin, Glucose, Hemoglobin A1c (if glucose > 7.75 mmol/L), Iron, LD, TIBC, Total Protein
Two 5 mL whole blood in EDTA (lavender-top) tubes, 10 mL urine in a yellow-top with blue fill line urinalysis preservative transport tube and 4 mL serum from a red-top tube and one gray-top tube
Urinalysis: Encourage clean-catch mid-stream samples to minimize contamination and improve accuracy. Label the sample; store and transport at room temperature.
2 EDTA tubes; one yellow-top, blue fill line urinalysis preservative transport tube; one gray-top tube and plastic screw-cap vial
Room temperature
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic • Urine: unpreserved
See Individual Analytes
Antenatal Panel - II Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78530
ABO group and Rh; Complete Blood Count Urinalysis,; HIV 1/2 Antibody, HbsAg, RPR, Thyroid profile (T3, T4, TSH)
Two 5 mL whole blood in EDTA (lavender-top) tubes, 10 mL urine in a yellow-top with blue fill line urinalysis preservative transport tube 4 mL serum from a red-top tube
Urinalysis: Encourage clean-catch mid-stream samples to minimize contamination and improve accuracy. Label the sample; store and transport at room temperature.
2 EDTA tubes; one yellow-top, blue fill line urinalysis preservative transport tube; and plastic screw-cap vial
Room temperature
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic • Urine: unpreserved
EIA, Chemiluminescence, Immuno Agglutination, Microscopy Examination, Reagent Impregnated Strips or dipstick indicates
See Individual test
Antibody to PM-Scl 37103
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature : Not defined, Refrigerated 3 days, -20oC Long term
MethodologyELISA
Clinical Significance
Scleroderma may be localized or diffuse (Progressive Systemic Sclerosis [PSS]) and may involve skin, gastrointestinal tracts, lungs, vascular and cardiac systems, and kidneys. PM-1 (PM-Scl) Antibody is present in approximately one-fourth of patients with the polymyositis/
scleroderma overlap syndrome, 8% of patients with polymyositis alone and 2-5% of patients
with scleroderma alone.
Anti-DNA, (dsDNA)
See “DNA (ds) Antibodies”
Anti-ENA Antibody
See “Sm and Sm/RNP Antibodies”
Anti-HBc, IgM
See “Hepatitis B Core IgM Antibody”
72
Anti-Phospholipid Syndrome Panel 3 Includes
Preferred Specimen(s)
Transport Container
Instructions
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78525
Antiphospholipid Antibody (IgG, IgM, IgA), Cardiolipin Antibody (IgG, IgM, IgA) aPTT, dRVVT
3 mL serum, 3 mL platelet-poor citrate plasma in a plastic vial
2 vials of sterile plastic screw-cap vial - Serum Frozen platelet-poor citrate plasma in a plastic vial
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 2500-3500 RPM. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and, using a plastic pipette, transfer platelet-poor plasma into a new plastic vial.
Plasma must be free of platelets (<10,000/uL). Freeze immediately and ship on dry ice.
Serum : Refrigerated : 2 - 8oC
Frozen Citrate plasma
Gross hemolysis • Hyperlipemia
ELISA, Coagulation
See individual test
A
B
Anti-Ribonucleic Protein Antigen
See “Sm and Sm/RNP Antibodies”
Anti-Smith Antibody
See “Sm and Sm/RNP Antibodies”
Anti-Streptolysin O Antibody (ASO) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
265
1 mL serum
Plastic screw-cap vial
Refrigerated 1 week
Gross hemolysis • Lipemia
Nephelometry
This test is a sensitive test for recent streptococcal infection. A rise in ASO begins about one week after infection and peaks two to four weeks later. ASO levels do not rise with cutaneous infections. In the absence of complications or reinfection, the ASO level will fall to preinfection levels within 6 to 12 months. Over 80% of patients with acute rheumatic fever and 95% of patients with acute glomerulonephritis have elevated levels of ASO.
Antithrombin III Activity 216
Preferred Specimen(s)
2 mL platelet poor 3.2% sodium citrate-anticoagulated plasma collected in a light blue-top tube; separate and freeze immediately
Instructions
Draw blood in light blue-top tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received thawed
Methodology
Chromogenic Substrate
Clinical Significance
Aids in the detection of hypercoagulable states associated with venous thrombotic episodes. May be useful in patients who appear to be hyporesponsive to heparin.
Antithrombin III, Antigen Patient Preparation
Preferred Specimen(s)
5158
Patient should abstain from anabolic steroids, Gemfibrozil, Warfarin (Coumadin®), heparin therapy, asparaginase, estrogens, gestodene and oral contraceptives optimally for 3 days prior to specimen collection. Overnight fasting is preferred.
1 mL plasma collected in a 3.2% sodium citrate (light blue-top) tube
73
A
B
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed • Freeze/thaw
Methodology
Fixed Rate/Time Nephelometry
Clinical Significance
Previously referred to as “Antithrombin,” antithrombin antigen is an inhibitor of several coagulation factors. Patients with low concentrations of Antithrombin Antigen may have a hereditary or acquired prothrombotic state. The Antigenic test differentiates a Type I from Type II deficiency.
Antinuclear Antibody Screen (ANA), ELISA 79004
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 24 hrs, -20oC Long term
Reject Criteria
Gross hemolysis, hyperlipemic, icteric samples;
MethodologyELISA
Clinical Significance
This ANA screening test is useful when SLE and other autoimmune disorers are suspected.
Anti-Neutrophil Cytoplasmic Antibody By IFA Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79006
C-ANCA and P- ANCA
1 mL serum
Plastic screw-cap vial
Room temperature : Not defined, Refrigerated 7 days, -20oC Long term
Gross hemolysis; Gross lipemic
Immunofluorescent Assay (IFA)
Testing for anti-neutrophil cytoplasmic antibodies (PANCA and/or ANCA-IBD) has been found to be useful in establishing the diagnosis of suspected vascular diseases (e.g., crescentric glomerulonephritis, microscopic polyarteritis and Churg-Strauss syndrome), bowel disease (e.g., Crohn’s Disease, ulcerative colitis, primary sclerosing cholangitis, and autoimmune hepatitis) as well as with other autoimmune diseases (e.g., drug-induced lupus, SLE, and Felty’s syndrome).
Apolipoprotein A1 78092
Preferred Specimen(s)
1.0 mL Serum
Instruction
12 hours fasting is required
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 8 days
Reject Criteria
Gross hemolysis, Hyperlipemia
Methodology
Nephelometry
Clinical Significance
Apolipoprotein A1 is the primary protein associated with HDL cholesterol. Like HDL cholesterol, increased concentrations are associated with reduced risk of cardiovascular disease.
Apolipoprotein B Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78093
1.0 mL Serum
12 hours fasting is required
Plastic screw-cap vial
Refrigerated 8 days
Gross hemolysis, Hyperlipemia
Nephelometry
There are two major forms of Apolipoprotein B, B-100 and B-48. B-100, synthesized in the liver, is the major protein in VLDL, IDL, and LDL cholesterol. B-48, synthesized in the
intestines, is essential for the assembly and secretion of chlyomicrons. Patients with increased concentrations of Apolipoprotein B are at increased risk of atherosclerosis.
APTT
See “Partial Thromboplastin Time, Activated (aPTT)”
74
Arthritis Panel 1 78515
Includes
Complete Blood Count (CBC), C Reative Protein (CRP), Uric Acid, Antinuclear Antibody Screen, ELISA, with Reflex to Titer, IFA, and Rheumatoid Factor (RF), Complement 4 (C4) and Urinalysis
Preferred Specimen(s)
3 mL Serum (2 vials each)
5 mL whole Blood – EDTA
10 mL urine - Urinalysis transport tube (yellow-top, blue fill line, preservative tube)
Transport Container
Sterile plastic screw-cap vial - Serum
Yellow-top, blue fill line urinalysis transport tube - Urine EDTA (lavender-top) tube – Whole Blood
Instructions
Maintain specimen at room temperature. If multiple draw, collect EDTA (lavender-top) tube last. Traumatic tap can introduce thromboplastin and trap WBC and platelets.
Transport Temperature
Whole blood: Refrigerated
Serum : Refrigerated 24 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemia • Hemolysis • Clotted • Received frozen
Methodology
IFA, Spectrophotometery, Microscopy Examination, Reagent Impregnated Strips or dipstick
Clinical Significance
See individual test
ASO
See “Anti-Streptolysin O Antibody (ASO)”
Aspartate Amino Transferase (AST) / (SGOT) 822
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 2 weeks
Reject Criteria
Gross hemolysis • Anticoagulants other than heparin
Methodology
Spectrophotometry (SP)
Clinical Significance
AST is widely distributed throughout the tissues with significant amounts being in the heart and liver. Lesser amounts are also found in skeletal muscles, kidneys, pancreas, spleen, lungs, and brain. Injury to these tissues results in the release of the AST enzyme to the general circulation. In myocardial infarction, serum AST may begin to rise within 6-8 hours after onset, peak within two days and return to normal by the fourth orfifth day post infarction. An increase in serum AST is also found with hepatitis, liver necrosis, cirrhosis, and liver metastasis.
AST
See “Aspartate Aminotransferase (AST)”
Barbiturates, Urine 78081
Preferred Specimen(s)Urine
Instruction
Collect urine sample without preservative
Transport Container
Plastic, leakproof container
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
Sample coating preservative
Methodology
Enzyme Immunoassay
Clinical Significance
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Basic Fever Panel Includes
Test Components
78584
CBC, ESR, Malarial Parasite, Urinalysis & Dengue NS1
831 - Malaria/Blood Parasites
5463 - Urinalysis, complete
75
A
B
A
B
6399 - CBC (Includes Diff/Plt)
79930 - ESR, Modified Westergren
79555 - Dengue NS1 Antigen
See individual test for details.
BCR/ABL FISH Assay 14641
Preferred Specimen(s)
3 mL Bone Marrow (Min1 mL) in transport media or
Green Top Sodium Heparin Tube (Random); Room Temperature;
-OR
3-5 ml Whole Blood (Min2-3 ml)
Green Top Sodium Heparin Tube (Random); Room Temperature;
Instructions
Clinical history and reason for referral are required with test order. Prior therapy and bone marrow transplant history should be provided with test order. This test is performed to detect the molecular rearrangement of the bcr and abl genes involved in translocation
(9;22), associated with chronic myelogenous leukemia (CML) and acute lymphocytic leukemi
a (ALL), using FISH (fluorescence in situ hybridization). This test may be used in the evaluation of Ph negative CML, complex rearrangements or for follow-up to therapy for
previously diagnosed Ph+ patients. Bone marrow transport medium is available upon request. Instructions, Specimen stability/rejection requirements: Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not reject.
Transport Container
Culture Transport Media-Green Top Sodium Heparin Tube
Transport Temperature
Room Temperature
Reject Criteria
Received Frozen; Hemolysed; Clotted
Methodology
Fluorescence In Situ Hybridization
Clinical Significance
To rule out the presence of a bcr/abl rearrangement in chronic myelogenous leukemia or Ph-positive acute leukemia.
Beta-2-Microglobulin, Serum Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 7 days
Hemolysis • Lipemia
Nephelometry
Beta-2-microglobulin normally passes through the glomerulus into the proximal tubule where much of it is reabsorbed. Serum levels are therefore an index of glomerular function. When impaired, serum levels rise in inverse ratio to glomerular filtration rate. Increased amounts of beta-2-microglobulin are excreted in several renal disorders, e.g., Balkan nephropathy, heavy metal poisoning and renal tubular disease due to therapeutic agents. Serial levels of beta-2microglobulin in serum and urine are used to evaluate transplant viability and anticipate rejection. Following a successful graft, serum levels decline toward normal. Increasing serum levels provide an early sign of rejection. Elevated levels are also noted in lymphproliferative disorders, neoplasms (malignant and benign), inflammatory disease, and autoimmune
diseases such as systemic lupus erythematosus (SLE) and Sjögren’s disease.
Benzodiazepine, Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
76
852
78082
10.0 mL Urine without preservative
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Bicarbonate
A
B
See “Carbon Dioxide”
Bilirubin, Direct 285
Preferred Specimen(s)
1 mL serum
Transport Container
Amber plastic screw-cap vial or foil-wrapped plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 2 weeks
Reject Criteria
Gross hemolysis • Anticoagulants other than heparin
MethodologySpectrophotometry
Clinical Significance
Measurement of the levels of bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, including hepatitis and gall bladder obstruction. The assessment of direct bilirubin is helpful in the differentiation of hepatic
disorders. The increase in total bilirubin associated with obstructive jaundice is primarily due to the direct (conjugated) fraction. Both direct and indirect bilirubin are increased in the serum with hepatitis.
Bilirubin, Fractionated Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Direct Bilirubin, Indirect Bilirubin (calculated), Total Bilirubin
1 mL serum
Amber plastic screw-cap vial or foil-wrapped plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Measurement of the levels of bilirubin is used in thediagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, including hepatitis and gall bladder obstructive disease. The assessment of direct bilirubin is helpful in the differentiation of hepatic disorders. The increase in total bilirubin associated with obstructive jaundice is primarily due to the direct
(conjugated) fraction. Both direct and indirect bilirubin are increased in the serum with hepatitis. In the newborn patient with hemolytic jaundice and neonatal jaundice, the increase in the total bilirubin is primarily due to the indirect (unconjugated) bilirubin fraction. This jaundice may be caused by Rh, ABO, or other blood group incompatibilities, by hepatic immaturity, or by hereditary defects in bilirubin conjugation.
Bilirubin, Total Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
7286
287
1 mL serum
Amber plastic screw-cap vial or foil-wrapped plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Measurement of the levels of bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, including hepatitis and gallbladder obstructive disease
Bladder Cancer (UroVysion™)
See “FISH, Vysis® UroVysion™, Bladder Cancer”
Blood Culture
See “Culture, Blood”
Blood Type and Rh
See “ABO Group and Rh Type”
Blood Urea Nitrogen
See “Urea Nitrogen (BUN)”
77
A
B
BOH (Bad Obstetrics History) Panel Includes
Test Components
78910
ToRCH 10, TSH, Cardiolipin IgA, Cardiolipin IgG, Cardiolipin IgM, Antiphospholipid Ab IgA, IgG, IgM, aPTT, dRVVT)
763 - Partial Thromboplastin time, activates (aPTT)
899 - TSH
4661 - Cardiolipin IgA
4662 - Cardiolipin IgG
4663 - Cardiolipin IgM
79531 - Torch 10
79047 - Antiphospholipid Ab IgG
79048 - Antiphospholipid Ab IgM
79049 - Antiphospholipid Ab IgA
See individual test for details
Bone Marrow Biopsy with Reticulin Stain 79199
Preferred Specimen(s)
Bone marrow biopsy in 10% buffered formalin or formalin fixed paraffin embedded tissue block
Transport Container
Paraffin block bag
Transport Temperature
Room temperature
Reject Criteria
Improper fixation; Receive Frozen
Methodology
Manual staining
Clinical Significance
Reticular fibers are present in normal human tissues and have a support function. They are normally found throughout the body but are most abundant in liver, spleen, kidney and lymph nodes. In certain tumors, reticulin is located in a characteristic position in relation to the actual tumor cells. Reticulin stains can therefore be an important diagnostic tool for the differential diagnosis of certain types of tumor.
Bone Marrow Examination Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78685
2 ml Bone marrow aspirate, 2 ml Whole blood, 4 Bone marrow aspirate smear and 2 Peripheral blood smears.
Bone marrow aspirate: Lavender top
Whole blood: Lavender top (EDTA)
Bone marrow aspirate smear: slide holder Peripheral blood smears: slide holder
Refrigerated 48 hrs
Receive Frozen
Morphology Review
Examination of bone marrow is required for further workup of hematological abnormalities observed in peripheral blood smear, staging for bone marrow involvement by metastatic tumor, assessment of infectious disease processes includes fever of unknown origin and in the evaluation of metabolic storage diseases.
B-Type Natriuretic Peptide (BNP) 37386
Preferred Specimen(s)
1 mL plasma from an EDTA (Lavender Top) tube. Collect specimen in a plastic Lavender Top tube.
Instruction
Mix thoroughly by inversion. Centrifuge and separate the plasma from the cells within one hour of collection. Transfer the plasma to a plastic vial using a plastic transfer pipette. Freeze specimen immediately for storage and transport.
Transport Container
Plastic, leakproof container
Transport TemperatureFrozen
Reject Criteria
Specimens received in glass vacutainers, Specimens not received frozen
MethodologyChemiluminescene
Clinical Significance
Rule out congestive heart failure (CHF) in symptomatic individuals, Determine prognosis in individuals with CHF or other cardiac disease, Maximize therapy in individuals with heart failure
78
BUN
See “Urea Nitrogen (BUN)”
CA 15-3, serum 5819
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient, Stable 1 week, Refrigerated 1 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
CA 15-3 may be useful for monitoring patients with metastatic breast cancer and certain ovarian cancers. The CA 15-3 values from sequential samples have a high correlation with the clinical course in most patients with metastatic breast cancer.
See CA 15-3 in the Hematology/Oncology section of Test Application and Interpretation.
CA 19-9, serum 4698
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 1 week
Reject Criteria
Gross hemolysis
MethodologyChemiluminescence
Clinical Significance
A large percentage of patients with gastrointestinal tumors (such as pancreatic, liver, gastric, colorectal tumors) and some other malignancies have been shown to have elevated serum or plasma CA 19-9 levels. The serum or plasma CA 19-9 levels may be useful for monitoring disease activity predicting relapse following treatment. CA 19-9 should not be used as a screening test.
See CA 19-9 in the Hematology/Oncology section of Test Application and Interpretation.
CA 125, Serum 29256
Preferred Specimen(s)
1 mL serum
Instructions
Specimen must be refrigerated or frozen if received by the laboratory more than 24 hours after collection
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs) 7 days
Reject Criteria
Gross hemolysis
MethodologyChemiluminescence
Clinical Significance
The CA 125 level can provide prognostic information in the follow-up management of patients with ovarian carcinoma. The assay should be used as an adjunctive test in the management of ovarian cancer patients. CA 125 is not recommended as a cancer screening
procedure to detect cancer in the general population. See Ovarian Cancer in the Hematology/
Oncology section of Test Application and Interpretation.
Calcium Random Urine 79838
Preferred Specimen(s)
10 mL random Urine. Collect urine with 25 mL 6N HCL
Transport Container
Sterile urine container or Plastic screw urine vial
Transport Temperature
Refrigerated preferred; Room temperature acceptable;Frozen acceptable
Reject Criteria
None
MethodologySpectrophotometry
Clinical Significance
Urinary calcium reflects dietary intake, rate of calcium absorption by the intestine and bone resorption. Urinary calcium is used primarily to evaluate parathyroid function and the effects of Vitamin D. A significant number of patients withy primary hyperparathyroidism will have elevated urinary calcium. However, there are other clinical entities that may be associated with increased urine calcium: Sarcoidosis, Paget’s disease of bone, Vitamin D intoxication, hyper thyroidism and glucocorticoid excess. Decreased urine calcium is seen with thiazide diuretics, vitamin D deficiency and familial hypocalciuric hypercalcemia.
79
C
D
Calcium, Serum C
D
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
303
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Serum calcium is involved in the regulation of neuromuscular and enzyme activity, bone metabolism and blood coagulation. Calcium blood levels are controlled by a complex interaction of parathyroid hormone, vitamin D, calcitonin and adrenal cortical steroids.
Calcium measurements are useful in the diagnosis of parathyroid disease, some bone disorders and chronic renal disease. A low level of calcium may result in tetany.
Calcium, 24-Hour Urine 1635
Includes
Creatinine, 24 Hour Urine
Preferred Specimen(s)
10 ml aliquot of a 24-hour collection. Collect urine with 25 mL 6N HCl.
Instructions
Refrigerate during and after collection. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first morning specimen voided the following morning at the same time as the previous morning’s first voiding. Record 24
hour urine volume on test request form and urine vial.
Transport Container
24-hour urine container
Transport Temperature
Refrigerated preferred; Room temperature acceptable; Frozen acceptable
Reject Criteria
None
MethodologySpectrophotometry
Clinical Significance
Urinary calcium reflects dietary intake, rate of calcium absorption by the intestine and bone resorption. Urinary calcium is used primarily to evaluate parathyroid function and the effects of Vitamin D. A significant number of patients withy primary hyperparathyroidism will have elevated urinary calcium. However, there are other clinical entities that may be associated with increased urine calcium: sarcoidosis, Paget’s disease of bone, vitamin D intoxication, hyperthyroidism and glucocorticoid excess. Decreased urine calcium is seen with thiazide diuretics, vitamin D deficiency, and familial hypocalciuric hypercalcemia.
Culture, Fungus, Blood ,Rapid Includes
Preferred Specimen(s)
inoculation
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Fungal culture. If culture is positive,identification will be performed. Antifungal susceptibilities are only performed when requested.
Submit blood for fungal culture, in BD BACTECR Mycosis or BD BACTECR Myco®
F/Lytic blood bottle(s). Gently mix the bottle(s) following
See Blood Cultures in the Bacteria section of Specimen Collection and Handling
Do not submit specimens in SPS, heparin, EDTA, and sodium citrate tubes
Do not refrigerate
In BD BACTECR Mycosis or BD BACTEC MycoF/Lytic blood bottle
Room temperature 48 hrs, Refrigerated 72 hrs, Frozen : Unacceptable
Blood specimens collected in EDTA, sodium citrate or anticoagulants other than SPS or heparin • Frozen specimens or specimens broken in transit
Rapid Automated Fluroscent Technique
Fungal sepsis constitutes one of the most serious infectious diseases. The detection of microorganisms in a patient’s blood has importance in the diagnosis of sepsis.
Campath®-1H Sensitivity (CD52) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
80
79886
10980
5 mL whole blood or bone marrow collected in a sodium heparin (green-top) tube
Sodium heparin (green-top) tube
Room temperature
Received refrigerated • Received frozen
Flow Cytometry
Campath® (alemtuzumab) is indicated for the treatment of patients with CD52 positive chronic lymphocytic leukemia.
See Campath Sensitivity (CD52) in the Hematology/Oncology section of Test Application and Interpretation.
Carbon Dioxide, Serum Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
310
1 full unopened spun gel barrier tube
Do not open tube
1 full, unopened spun gel barrier tube
Ambient 5 days, Refrigerated 2 weeks
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance
Carcinoembryonic Antigen
See “CEA”
Cardio CRP (hsCRP) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10124
1 mL serum
Plastic screw-cap vial
Refrigerated 1 week
Gross hemolysis • Lipemia
End Point Nephelometry
Useful in predicting risk for cardiovascular disease.
See Cardio CRP™ in the Cardiovascular Tests section of Test Application and Interpretation.
Cardiolipin IgA Ab 4661
Preferred Specimen(s)
1 ml serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature : Not defined, Refrigerated : Not defined, -20oC Long term
MethodologyELISA
Clinical Significance
Cardiolipin antibodies (CA) are seen in a subgroup of patients with autoimmune disorders, particularly Systemic Lupus Erythematosus (SLE), who are at risk for vascular thrombosis, thrombocytopenia, cerebral infarct and/or recurrent spontaneous abortion. Elevations of CA associated with increased risk have also been seen in idiopathic thrombocytopenic purpura, rheumatoid and psoriatic arthritis, and primary Sjögren’s syndrome.
See Non-Lipid Markers in the Cardiovascular chapter, Venous Thrombosis: Laboratory Support of Risk Assessment and Diagnosis in the Coagulation chapter and Cardiolipin Antibodies in the Immunology section of Test Application and Interpretation.
Cardiolipin IgG Ab 4662
Preferred Specimen(s)
1 ml serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature : Not defined, Refrigerated : Not defined, -20oC Long term
MethodologyELISA
Clinical Significance
Cardiolipin antibodies (CA) are seen in a subgroup of patients with autoimmune disorders, particularly Systemic Lupus Erythematosus (SLE), who are at risk for vascular thrombosis, thrombocytopenia, cerebral infarct and/or recurrent spontaneous abortion. Elevations
of CA associated with increased risk have also been seen in idiopathic thrombocytopenic purpura, rheumatoid and psoriatic arthritis, and primary Sjögren’s syndrome.
See Non-Lipid Markers in the Cardiovascular chapter, Venous Thrombosis: Laboratory Support of Risk Assessment and Diagnosis in the Coagulation chapter and Cardiolipin Antibodies in the Immunology section of Test Application and Interpretation.
Cardiolipin IgM Ab Preferred Specimen(s)
Transport Container
Transport Temperature
4663
1 ml serum
Plastic screw-cap vial
Room temperature : Not defined, Refrigerated : Not defined, -20oC Long term
81
C
D
C
D
MethodologyELISA
Clinical Significance
Cardiolipin antibodies (CA) are seen in a subgroup of patients with autoimmune disorders, particularly Systemic Lupus Erythematosus (SLE), who are at risk for vascular thrombosis, thrombocytopenia, cerebral infarct and/or recurrent spontaneous abortion. Elevations of CA associated with increased risk have also been seen in idiopathic thrombocytopenic purpura, rheumatoid and psoriatic arthritis and primary Sjögren’s syndrome.
See Non-Lipid Markers in the Cardiovascular chapter, Venous Thrombosis: Laboratory Support of Risk Assessment and Diagnosis in the Coagulation chapter and Cardiolipin Antibodies in the Immunology section of Test Application and Interpretation.
Cardiolipin Antibody Panel (IgA, IgG, IgM) 36189
Order Code 7352 (screen only)
Preferred Specimen(s)
3mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature/ Refrigerated : Not defined, -20oC Long term
MethodologyELISA
Clinical Significance
Cardiolipin Antibodies (CA) may be seen during the convalescent phase of acute bacterial and viral infections (including syphilis). All patients that test positive for CA should be retested after six to eight weeks to rule out transient antibodies Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages (women).
CBFB beta/MYH11 inv(16) RT PCR, CELLS Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
14992
5 mL Whole blood
EDTA (lavender-top)
Refrigerated, stable 72 hrs
Received Frozen
Real-Time Reverse Transcriptase Polymerase Chain Reaction
This assay is a real-time quantitative RT-PCR assay. Extracted sample RNA is subjected to two separated tubes of real-time RT-PCR reaction to measure the quantity of the fused mRNA and the mRNA of an internal control. The results are reported as a ratio between the quantity of the fused mRNA to the internal control mRNA. In general, normal person does not have any fused mRNA and the report will show ‘ ‘negative’ ‘ without any number. The positive sample will report the ratio. The analytical sensitivity of this test is 1 tumor cell in 100,000 normal cells. The mRNA transcripts of samples produced by the tumor cells vary widely from patient to patient, making it difficult to compare the quantitative results between patients. The quantitative results should only be used to monitor the patient’s own tumor load sequentially.
CBFB/MYH11, Inversion 16 FISH Assay 14642
Preferred Specimen(s)
3 mL Bone Marrow (Min1 mL)
Green Top Sodium Heparin Tube (Random); Room Temperature;
-OR
3 mL Whole Blood (Min1 mL)
Green Top Sodium Heparin Tube (Random); Room Temperature;
Instructions
Clinical history and reason for referral are required with test order. Prior therapy/transplant information should be submitted with test order. Interphase nuclei are examined microscopi
cally for the presence of break apart signals that indicate rearrangement of the CBFB gene, located in chromosome band 16q22, such as inv(16)(p13;q22) and t(16;16)(p13;q22), using FISH (fluorescence in situ hybridization). Rearrangements of CBFB are found predominantly in myeloid leukemia (M4eo).This test is useful for detecting cell populations that may not be mitotically active, that have suboptimal chromosome morphology, or that have variant or
cryptic rearrangements. Bone marrow transport medium is available upon request. Instructions, Specimen stability/rejection requirements: Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not reject.
82
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Culture Transport Media
Room Temperature
Frozen: Unacceptable
Fluorescence In Situ Hybridization
To rule out the presence of a CBFB rearrangement, associated with the majority of acute myelomonocytic leukemia with eosinophilia ( M4eo ).
Carcinoembryonic Antigen (CEA) C
D
978
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Note: Ambient 5 days (Frozen acceptable), Refrigerated 14 days
MethodologyChemiluminescence
Clinical Significance
Increased serum CEA levels have been detected in persons with primary colorectal cancer and in patients with other malignancies involving the gastrointestinal tract, breast, lung, ovarian, prostatic, liver and pancreatic cancers. Elevated serum CEA levels have also been detected in patients with nonmalignant disease, especially patients who are older or who are smokers. CEA levels are notuseful in screening the general population for undetected cancers. However, CEA levels provide important information about patient prognosis, recurrence of tumors after surgical removal, and effectiveness of therapy.
See Carcinoembryonic Antigen (CEA) in the Hematology/Oncology section of Test Application and Interpretation.
Ceruloplasmin Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
326
1.0 mL Serum, EDTA/Heparin Plasma
Plastic screw cap vial
Refrigerated 1 week
Hemolysis, Hyperlipemia
Nephelometery
Approximately 80% of the body’s copper is bound to Ceruloplasmin. Ceruloplasmin is an acute phase reactant. Concentrations are decreased in approximately 75% of patients with Wilson disease, an autosomal recessive disorder of copper metabolism.
Celiac Disease Panel Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
15980
Tissue Transglutaminase IgA, Total IgA, Gliadin Antibody IgA
2 mL serum
Plastic screw-cap vial
Refrigerated (cold packs)
ELISA, Nephlometry
Patients with celiac disease display a hypersensitivity to gluten (wheat) in their diet. This panel helps differentiate patients with celiac disease from patients with other inflammatory bowel diseases.
Chikungunya Fever, Igm 19915
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature : Not defined, Refrigerated 4 days, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyELISA
Clinical Significance
See Chikungunya Fever in the Infectious Disease section of Test Application and Interpretation.
Chikungunya Fever, IgG Preferred Specimen(s)
Transport Container
79093
1.0 mL serum
Plastic screw-cap vial
83
C
D
Transport Temperature
Room temperature : Not defined, Refrigerated 4 days, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyELISA
Clinical Significance
Chikungunya virus is a mosquite-borne alpha-virus associated with large outbreaks of a febrile illness in Africa, Ocean Islands, India, and Southeast Asia. These infections are associated with severe arthralgia, rash, and headache. Cases acquired by US residents
during international travel have been described.
See Chikungunya Fever in the Infectious Disease section of Test Application and Interpretation.
Chloride 330
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Stable 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Anticoagulants other than heparin
Methodology
Ion Selective Electrode (ISE)
Clinical Significance
Serum chloride is the major extracellular anion and counter-balances the major cation, sodium, maintaining electrical neutrality of the body fluids. Two thirds of the total anion concentration in extracellular fluids is chloride and it is significantly involved in maintaining proper hydration and osmotic pressure. Movement of chloride ions across the red blood cell membrane is essential for the transport of biocarbonate ions in response to changing concentrations of carbon dioxide. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Chloride, 24-Hour Urine Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
368
Creatinine, 24 Hour Urine
10 mL 24-hour urine
Collect without preservatives. Refrigerate during and after collection. Aliquot unpreserved specimen before adding acid. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first morning specimen voided the following morning at the same time as the previous morning’s first voiding. Record 24-hour urine volume on test request form and urine vial.
Plastic, screw-cap container
Refrigerated & ambient 7 days, Stable 1 week
None
Ion Specific Electrode (ISE)
Urine chloride excretion approximates the dietary intake. The chloride content of most foods parallels that of sodium. An increase in urine chloride may result from water deficient dehydration, diabetic acidosis, Addison’s disease and salt-losing renal disease. Decreased urine levels are seen in congestive heart failure, severe diaphoresis and in hypochloremic
metabolic alkalosis due to prolonged vomiting.
Cholesterol, LDL
See “Direct LDL”
Cholesterol, HDL
See “HDL Cholesterol”
Cholesterol, Total Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
84
334
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Clinical Significance
Total LDL and HDL cholesterol, in conjunction with a triglyceride determination, provide valuable information for the risk of coronary artery disease. Total serum cholesterol analysis is useful in the diagnosis of hyperlipoproteinemia, atherosclerosis, hepatic and thyroid diseases. See Markers of Lipidemia in the Cardiovascular section of Test Application and Interpretation.
Chorionic Gonadotropin
C
D
See “hCG, Qualitative, Urine”
Chromosome Analysis / Peripheral Blood Leukocyte Culture for Genetic Analysis (Karyotyping)
14627
Preferred Specimen(s)
4.0 mL Sodium Heparin Peripheral Blood, Cord blood
Instruction
A test requisition with preliminary diagnosis and clinical history should accompany the specimen
Transport Container
Collection in Sodium Heparin Green top tube
Transport Temperature
Room Temperature
Reject Criteria
Specimens received frozen, hemolyzed, or those received in a non-sodium heparin vacutainer tubes; Clotted
MethodologyCulture
Clinical Significance
Peripheral blood is the most commonly utilized tissue for determination of constitutional karyotypes and this test looks at numerical and structural chromosomal rearrangement. Most common indication for study include repeated spontaneous abortion, infertility, developmental delays, dysmorphology, mental retardation, suspected sex chromosome abnormalities and for parents requiring genetic counseling.
Chromosome Analysis, Hematologic, Malignancy 14636
Preferred Specimen(s)
4.0 mL Sodium Heparin, Bone Marrow / Astirate
Instruction
A test requisition with a current CBC and preliminary diagnosis should accompany the specimen
Transport Container
Collection in Sodium Heparin tube / Bone Marrow kit supplied by Lab
Transport Temperature
Room Temperature
Reject Criteria
Specimens received frozen, hemolyzed, or those received in a non-sodium heparin vacutainer tubes; Clotted; Dry taps
MethodologyCulture
Clinical Significance
Cytogenetics of hematologic disorders attempts to define and interpret chromosomal aberrations that occur in neoplastic cells associated with leukemia and other hematologic malignancies. Chromosome abnormalities in cancer cells of patients with malignant hematologic disorders including acute myeloid and lymphoblastic leukemias, chronic myelogenous leukemia (CML, CGL), myelodysplastic and myeloproliferative disorders; may aid in the diagnosis, prognosis, treatment, and etiology of disease.
Chromosome Analysis, Mosaicism 14632
Preferred Specimen(s)
4.0 mL Sodium Heparin Blood
Instruction
A test requisition with preliminary diagnosis and clinical history should accompany the specimen
Transport Container
Collection Sodium Heparin tube
Transport Temperature
Room Temperature
Reject Criteria
Specimens received frozen, hemolyzed, or those received in a non-sodium heparin vacutainer tubes, Clotted.
MethodologyCulture
Clinical Significance
The chromosome analysis, Mosaicism test rules out the following:
• Trisomies such as trisomy 21 (Down syndrome), Trisomy 18, Trisomy 13.
• Sex chromosome abnormalities such as Turner syndrome (45, X) and Klinefelter syndrome (47, XXY).
• Most rearrangement including Robertsonian translocation, reciprocal translocation and inversions.
• Most marker chromosomes. Mosaicism above 6% (at 95% confidence level).
85
Cobalamine
See “Vitamin B12”
Cocaine Metabolites By GC/MS (Urine) C
D
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
20 mL urine, random collection
Plastic urine container
Room temperature 7 days, Refrigerated 14 days
Gas Chromatography/Mass Spectrophotometry (GC/MS)
Cocaine Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78083
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Complement 3 (C3) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78050
0.5 mL Serum
Overnight fasting is preferred. Serum should be separated immediately from clot.
Plastic screw cap vial
Refrigerated 1 week
Grossly hemolysed specimen
Nephelometry
C3 is the most abundant complement protein and is critical to activation of both the classical and alternative pathways. C3 is an acute phase reactant. Decreased concentrations are observed in patients with systemic lupus erythematosus (SLE), endocarditis, and disseminated intravascular coagulation (DIC). Congenital deficiency of C3 places such patients at high risk for recurrent bacteremia.
Complement 4 (C4) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78051
0.5 mL Serum
Overnight fasting is preferred. Serum should be separated immediately from clot.
Plastic screw cap vial
Refrigerated 1 week
Grossly hemolysed specimen
Nephelometry
C4 is critical to activation of the classical pathway.Concentrations of C4 are decreased in patients with systemic lupus erythematosus (SLE), immune complex disease, and hereditary angioedema. Congenital absence of C4 places such patients at increased risk of bacteremia, especially infections by S. pneumoniae.
Codeine
See “Opiates, Clinical Screen with Confirmation”
Collagen Cross-Linked N-Telopeptide
See “Collagen Cross-Linked N-Telopeptide (NTx), Urine”
86
5530
Complete Blood Count
See “CBC (includes Differential and Platelets)”
Complete Blood Count (CBC) with Peripheral blood smear and ESR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Two 3 mL whole blood in EDTA vacutainer, fresh slide smear
Slide smear should be dry and thin
EDTA Vial (lavender top tube), Sodium citrate vial (black-top tube)
Room temperature or Refrigerated; Stability 48 hrs
Heparinized sample; frozen; hemolyzed specimen
Cell Counter/Microscopic examination/ Westergren Method
See individual tests.
ESR testing should be performed within 24 hours of specimen collection. An alternative acute inflammatory marker is C reactive Protein (CRP).
Complete Blood Count (CBC) with Peripheral blood smear Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78512
3 mL whole blood in EDTA vacutainer, fresh slide smear
Slide smear should be dry and thin
EDTA Vial (lavender-top) tube
Room temperature or Refrigerated; Stability 48 hrs
Heparinized sample; Received frozen
Cell counter/Microscopic examination
An automated blood analysis provides insights into medical conditions associated with changes in red blood cells, white blood cells, and platelets. The peripheral blood smear may be useful to describe morphologic abnormalities and leukemias.
Complete Blood Count (CBC) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78511
6399
3ml Whole blood in EDTA vial, fresh slide smear
Slide smear should be dry and thin
EDTA vial (lavender-top) tube
Room temperature or Refrigerated; Stability 48 hrs
Frozen; heparinized sample
Cell counter, Methemoglobin
An automated blood analysis provides insights into medical conditions associated with changes in red blood cells, white blood cells, and platelets. The peripheral blood smear may be useful to describe morphologic abnormalities and leukemias.
Compound S
See “11-Deoxycortisol, LC/MS/MS”
Conjugated Bilirubin
See “Bilirubin, Direct”
Cortisol – Total 367
Preferred Specimen(s)
1 mL serum
Note: Assay not recommended when patient is receiving prednisone/prednisolone therapy due to cross reactivity with the antibody used in this assay.
Instruction
Assay not recommended when patient is on prednisone/prednisolone therapy due to cross reactivity with the antibody used in this assay
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
MethodologyChemiluminescence
Clinical Significance
Cortisol is increased in Cushing’s Disease and decreased in Addison’s Disease (adrenal insufficiency)
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Cortisol, A.M. C
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4212
Patient Preparation
Assay is not recommended when patient is receiving prednisone/prednisolone therapy due to cross reactivity with the antibody used in this assay
Preferred Specimen(s)
1 mL serum
Instructions
Collect specimen between 7-9 A.M. Indicate thecollection time on the specimen container and test requisition.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
MethodologyChemiluminescence
Clinical Significance
Cortisol is increased in Cushing’s Disease and decreased in Addison’s Disease (adrenal insufficiency)
Cortisol, P.M. 4213
Patient Preparation
Assay not recommended when patient is receiving prednisone/prednisolone therapy due to cross reactivity with the antibody used in this assay
Preferred Specimen(s)
1 mL serum
Instructions
Collect specimen between 3-5 P.M. Indicate collection time on specimen container and test requisition.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
MethodologyChemiluminescence
Clinical Significance
Cortisol is increased in Cushing’s Disease and decreased in Addison’s Disease (adrenal insufficiency)
Coombs Test - Indirect Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
795
3 ml Whole blood
EDTA (lavender top tube), Red top tube
Refrigerated, Stable 48 hrs
Received frozen
Agglutination Method
The indirect Coombs test is used in prenatal testing of pregnant women, and in testing blood prior to a blood transfusion. It detects antibodies against RBCs that are present unbound in the patient’s serum. In this case, serum is extracted from the blood, and the serum is
incubated with RBCs of known antigenicity. If agglutination occurs, the indirect Coombs test is positive. A negative test in a woman who is pregnant means that she has not developed detectable antibodies against the blood of her fetus; e.g., no Rh sensitization.
Coombs Test - Direct
See “Direct Anti Globulin test (DAT)”
C-Peptide 531
Preferred Specimen(s)
1.0 mL Serum
Instruction
Overnight fasting is required
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject Criteria
Grossly hemolysed, Cord blood
Methodology
Chemiluminescent Enzyme Immunoassay
Clinical Significance
C-Peptide is useful in distinguishing insulin-secreting tumors, i.e., insulinomas, from exogenous insulin administration. C-Peptide concentrations are severely depressed or absent in Type I diabetes mellitus. CPeptide is also useful in monitoring patients who have received islet cell or pancreatic transplants.
C-Reactive Protein (CRP) Preferred Specimen(s)
Transport Container
88
1 mL serum
Plastic screw-cap vial
4420
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Refrigerated 1 week
Gross hemolysis • Lipemia
Nephelometry
Increased CRP levels are found in inflammatory conditions including: bacterial infection, rheumatic fever, active arthritis, myocardial infarction, malignancies and in the post-operative state. This test cannot detect the relatively small elevations of CRP that are associated with increased cardiovascular risk.
See Non-Lipid Markers of Cardiovascular Disease in the Cardiovascular section of Test Application and Interpretation
Creatine Kinase (CK), Total Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
374
1 mL serum
If CK and CK Isoenzymes are ordered together, specimen must be submitted frozen
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Test for myocardial infarction and skeletal muscle damage. Elevated results may be due to: myocarditis, myocardial infarction (heart attack), muscular dystrophy, muscle trauma or excessive exercise.
Creatinine, Random Urine 8459
Preferred Specimen(s)
10 mL random urine - no preservative
Transport Container
Plastic screw-cap container
Transport Temperature
Ambient 7 days, Refrigerated 62 days
MethodologySpectrophotometry
Clinical Significance
Creatinine is the endproduct of creatine metabolism. Creatine is present primarily in muscle and the amount of creatinine produced is related to total skeletal muscle mass. Daily creatinine production is fairly constant except when there is massive injury to muscle. The kidneys excrete creatinine very efficiently and blood levels and daily urinary excretion of creatinine fluctuates very little in healthy normal people. Since blood and daily urine excretion of creatinine shows minimal fluctuation, creatinine excretion is useful in determining whether 24-hour urine specimens for other analytes (e.g., protein) have been completely and accurately collected.
Creatinine with Glomerular Filtration Rate, Estimated (eGFR) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
375
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Serum creatinine is useful in the evaluation of kidney function and in monitoring renal dialysis. A serum creatinine result within the reference range does not rule out renal function impairment: serum creatinine is not sensitive to early renal damage since it varies with age, gender and ethnic background. The impact of these variables can be reduced by an estimation of the glomerular filtration rate using an equation that includes serum creatinine, age and gender.
See Creatinine with Glomerular Filtration Rate, Estimated (eGFR)
see also Estimated Glomerular Filtration Rate in the Chronic Kidney Disease section of Test Application and Interpretation.
Crescentic Glomeruloephritis
See “Myeloperoxidase Antibody (MPO)”
Creatinine, 24-Hour Urine Preferred Specimen(s)
381
2 mL urine
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Instructions
Record 24-hour urine volume on test request form and urine vial.
Transport Container
24-hour urine container
Transport Temperature
Ambient 7 days, Refrigerated 62 days
Reject Criteria
Received at room temperature
MethodologySpectrophotometry
Clinical Significance
Creatinine is the end product of creatine metabolism. Creatine is present primarily in muscle and the amount of creatinine produced is related to total skeletal muscle mass. Daily creatinine production is fairly constant except when there is massive injury to muscle. The kidneys excrete creatinine very efficiently and blood levels and daily urinary excretion of creatinine fluctuates very little in healthy normal people. Since blood and daily urine excretion of creatinine shows minimal fluctuation, creatinine excretion is useful in determining whether 24-hour urine specimens for other analytes (e.g., protein) have been completely and accurately collected.
CRP
See “C-Reactive Protein (CRP)”
Culture, Genital Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
4558
Vaginal, endocervical, urethral, prostatic secretions
Sterile Leak-proof Container
Room Temperature 48 hrs for Swab
Frozen Swabs, Specimens submitted in formalin or other preservative
Conventional Culture,Microscopic & Automation
Used for diagnosis and treatment of infection. Proper interpretation of culture results depends on specimen source and known pathogenicity of the organism isolated
Culture, Genital (Charcoal Media) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Vaginal, endocervical, urethral, prostatic secretions.
Collect specimen using culture swab transport device. Indicate source of specimen on both the test requisition and specimen transport device.
Blue cap culture swab device with amies gel transport medium
Room temperature 48 hrs for Swab
Expired transport swabs • Frozen specimens or requests for anaerobic culture
Bacterial culture, aerobic includes routine isolation and identification procedures antibiotic susceptibility testing when appropriate
The significance of any isolate(s), in pure or mixed culture, must be assessed with respect to the source cultured, the organism’s pathogenic potential, the possibility of colonization versus infection, and the number of other organisms recovered from the same culture.
Culture Fungus other than Blood Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
45559
4553
Fungal smear, Fungal culture. If culture is positive identification will be performed
Raw specimen from any source except blood
Sterile container • Swabs in Amies liquid transport medium, or equivalent
Room temperature 72 hrs for transport swabs; 2 weeks for hair, skin and nail
Refrigerated : 72 hrs for unpreserved specimens other than hair, skin and nail
Conventional Culture, Microscopic & Automation
This examination can provide the physician with early information regarding the possible need for antifungal treatment.
Culture, Aerobic Bacteria with Susceptibility 4550
Includes
If culture is positive, identification will be performed. In addition, antibiotic susceptibilities are only performed when appropriate.
Preferred Specimen(s)Fluids
Instructions
Aseptic collection
Transport Container
Sterile, screw-cap vial
Transport Temperature
Room temperature
90
Reject Criteria
Methodology
Clinical Significance
Received frozen; non-viable isolates
Conventional Culture, Microscopic & Automation
Antibiotic susceptibility testing is important in the selection of effective therapy to eradicate infection that if untreated can cause or lead to the development of abscess, tissue damage, and sepsis
Culture, Aerobic Blood Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Culture, Throat Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
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Aerobic culture. If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
Adults: 8-10 mL of blood in each of BD BACTEC® Plus Aerobic/F (silver label/gray cap) and Lytic/10 Anaerobic/F bottles (purple label and cap) Neonates and Children 1 to 6 years: 1-3 mL of blood in a BACTEC Peds Plus®/F bottle Children weighing 30-80 lbs: 3 mL of blood in BD BACTEC Peds Plus®/F bottle or 8-10 mL of blood in BD BACTEC® Plus Aerobic/F and Lytic/10 Anaerobic/F bottles Note: Please label requisition “Rule out Anthrax” if suspected.
See Blood Cultures in the Bacteria section of Specimen Collection and Handling
Do not submit specimens in SPS, heparin, EDTA, and sodium citrate tubes.
Do not refrigerate
Note: Please label requisition as “Rule Out Anthrax” if suspected.
BD BACTEC® Plus Aerobic/F (silver label/gray cap) and Lytic/10 Anaerobic/F bottles (purple label and cap), or BD BACTEC Peds Plus®/F
Room temperature 48 hrs
Blood specimens collected in EDTA, sodium citrate or anticoagulants other than SPS or heparin • Frozen specimens or specimens broken in transit
Rapid Automated Fluroscent Technique
Bacterial sepsis constitutes one of the most serious infectious diseases. The detection of microorganisms in a patient’s blood has importance in the diagnosis and prognosis of endocarditis, septicemia, or chronic bacteremia.
Culture, Stool (Salmonella/Shigella/Campylobacter) Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
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10045
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
Stool submitted in Cary-Blair stool culture transport medium See Stool Specimens in the Bacteria section of Specimen Collection and Handling
Cary-Blair transport (or appropriate stool transport medium)
Room temperature. Do not refrigerate
Unpreserved, at any temperature • Frozen specimens in Cary-Blair transport medium • Expired transport medium • Specimen in diaper or parisitology transport vials
Conventional Culture,Microscopic & Automation
394
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
Collect throat specimen using either a BD™ red-cap
Amies liquid transport medium swab or BD™ blue-cap, Amies gel medium swab.
See Nasopharyngeal Specimens in the Bacteria section of Specimen Collection and Handling.
Transport swab
Room temperature 48 hrs in Hi culture transport swab & Amies medium
Expired transport device • Frozen • Request for anaerobic culture
Conventional Culture,Microscopic & Automation
The significance of any isolate in pure or mixed culture must be assessed with respect to the source cultured, the organism’s pathogenic potential, the possibility of colonization versus infection, and the number of other organisms recovered in the same culture. This test may be useful in the detection of agents of epiglottis and thrush and A. haemolyticum.
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Culture, Urine, Routine C
D
Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
395
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
Clean, sterile plastic or waxed paper cups are used to collect urine before transfer to a 5 ml Vacutainer gray top urine tranport tube.
Urine collection kits (gray-top tube); sterile container for specimens <5 mL (for pediatric patients only)
Room temperature for preserved urine : 48 hrs; Refrigerated 48 hrs in Vaccutainer brand urine C & S transport kit; Refrigerated : 24 hrs in sterile urine container.
If urinalysis transport tube is received • Unpreserved urine >5 mL • Preserved urine >2 days old • Urine tube not filled to minimum fill line • Foley tips • Frozen specimens • Specimens from catheter bag • Urine in urinalysis transport tube
Conventional Culture,Microscopic & Automation
This culture is designed to quantitate the growth of significant bacteria when collected by the Clean Catch Guidelines or from indwelling catheters. Quantitative culturing of urine is an established tool to differentiate significant bacteruria from contamination introduced during voiding. This test has a reference range of less than 1,000 bacteria per mL. More than 95% of Urinary Tract Infections (UTI) are attributed to a single organism. Infecting organisms are usually present at greater that 100,000 per mL, but a lower density may be clinically important. In cases of UTI where more than one organism is present, the predominant organism is usually significant and others are probably urethral or collection contaminants. When multiple organisms are isolated from patients with indwelling catheters, UTI is
doubtful and colonization likely.
Culture, Body Fluid 4473
Includes
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
Preferred Specimen(s)
All body fluids from sterile sites (CSF, Ascitic fluid, Pleural fluid, Synovial fluid)
Instructions
Collect aseptically and label it appropriately.
Transport Container
Designated bottles supplied by manufacturer.
Transport Temperature
Room temperature 24 hrs; Refrigerated : Do not refrigerate cerebrospiral fluid
Reject Criteria
No swabs are acceptable. Samples like urine, sputum, swabs, stool are unacceptable; received frozen.
Methodology
Conventional Culture,Microscopic & Automation
Clinical Significance
Bacterial infections may cause development of abscess, tissue damage, or sepsis, if untreated.
Culture, Sputum Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
4556
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
3 mL sputum
Instruct patient to gargle with water and to cough deeply to collect 3 mL deep respiratory specimen in a sterile, leak proof container
Sterile screw-cap container
Refrigerated, stable 1 week
Received at room temperature, frozen; Contaminated; Non-viable isolate
Conventional Culture,Microscopic & Automation
Respiratory infections may cause bronchitis and pneumonia. Antibiotic susceptibility testing is important in the selection of effective therapy.
Cyanocobalamin
See “Vitamin B12”
Cyclic Citrullinated Peptide (CCP) Antibody IgG Preferred Specimen(s)
Transport Container
92
1 mL serum
Plastic screw-cap vial
11173
Transport Temperature
Room temperature 8 hrs, Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Gross lipemia • Plasma
MethodologyELISA
Clinical Significance
A synthetic circular peptide containing citrulline called CCP IgG (cyclic citrullinated peptide) has been found to be better at discriminating Rheumatoid Arthritis patients from other patients than either the perinuclear autoantibody test or the test for rheumatoid factor. Approximately 70% of patients with Rheumatoid Arthritis are positive for Anti-CCP IgG, while only about
2% of random blood donors and disease controls subjects are positive.
Cysticercus Antibody IgG (Serum) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79494
1 mL Serum
Instructions: Centrifuge and immediately separate serum specimens from the cells into clean, plastic, screw-capped vial(s). Transport refrigerated (cold packs).
Red-top tube (no gel)
Room Temperature: Not defined, Refrigerated : Not applicable, -20oC Long term
Gross hemolysis • Hyperlipemia
Enzyme-Linked Immunosorbent Assay
Cysticercosis is caused by infection with the larval form (cysticercus) of the pork tapeworm Taenia solium. Clinical manifestations of cysticercosis most commonly result from the lodging of cysticerci in brain and neural tissue. Common symptoms of eurocysticercosis
include seizures and convulsions. Antibodies from other parasitic infections, especially echinococcosis, may cross-react in the Cysticercus IgG ELISA. Confirmation of positive ELISA results by the Cysticercus IgG Antibody Western Blot is recommended.
Cytomegalovirus Antibodies (IgG, IgM) 79533
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient : Not defined, Refrigerated 3 days
Reject Criteria
Gross Hemolysis
MethodologyCLIA
Clinical Significance
Intrauterine or congenital CMV infections occur in 0.5 to 2.2% of all live births. Symptomatic congenital infections usually occur in infants born to nonimmune mothers who have primary infections during pregnancy. Latency and reactivation of CMV influence the interpretation
of serological results. A single positive CMV IgG result is and indication of present or past infection. The presence of CMV IgM suggests a recent CMV exposure but does not differentiate between primary infection and reactivation.
Cytomegalovirus Antibodies (IgG) 79910
Preferred Specimen(s)
1 mL serum
Transport Container
No additive (red-top) or Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days
Reject Criteria
Received frozen; Gross hemolysis
MethodologyCLIA
Clinical Significance
The presence of IgG antibodies demonstrate prior infection with Cytomegalovirus (CMV). Seroconversion of CMV IgG from negative to positive or a significant rise in antibody level between paired sera is indicative of active or recent infection. Testing for IgM antibodies
(also indicative of active or recent infection) is recommended to support a diagnosis of active disease.
Cytomegalovirus Antibodies (IgM) 79912
Preferred Specimen(s)
1 mL serum
Transport Container
No additive (red-top) or Plastic screw-cap vial.
Transport Temperature
Refrigerated 3 days
Reject Criteria
Received frozen; Gross hemolysis.
MethodologyCLIA
Clinical Significance
Exposure to cytomegalovirus (CMV) occurs throughout life and by adulthood, 50 to 90% of 93
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the population is seropositive for CMV antibodies. CMV is spread by close contact, sexual transmission, perinatal or congenital transmission, and through blood transfusions and tissue transplants. Intrauterine or congenital infections occur in 0.5 to 2.2% of all live births. Symptomatic congenital infections usually occur in infants born to nonimmune mothers who have primary infections during pregnancy. Latency and reactivation of CMV influence the interpretation of serological results. A single positive CMV IgG result is an indication
of present or past infection. The presence of CMV IgM suggests a recent CMV exposure but does not differentiate between primary infection and reactivation.
D-Dimer, Semi-Quantitative Order Code
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79007
1 mL Plasma
Do not thaw
3.2% Sodium Citrate (light blue top tube) or Plastic screw vial (Plasma)
Frozen, stable 1 month
Received Room temperature; Hemolysis
Latex agglutination
D-Dimer is one of the measurable activation by-products fibrin degradation within the fibrinolytic system. Quantitation of D-Dimer assesses fibrinolytic activation and intravascular thrombosis. D-Dimer is of particular value in excluding the diagnosis of venous thromboembolism among patients at high risk.
Dengue Fever Antibody (IgG) 37579
Preferred Specimen(s)
1.0 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Received room temperature
MethodologyELISA
Clinical Significance
Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of a RNA flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
See Dengue Fever in the Infectious Disease section of Test Application and Interpretation.
Dengue Fever Antibody (IgM) 37580
Preferred Specimen(s)
1.0 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Received room temperature
MethodologyELISA
Clinical Significance
Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of a RNA flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
See Dengue Fever in the Infectious Disease section of Test Application and Interpretation.
Dengue NS1 Antigen 79555
Preferred Specimen(s)
0.5 mL Serum
Transport Container
Plastic screw cap vial
Transport TemperatureRefrigerated
Reject Criteria
Grossly hemolyzed, lipemic specimens
Methodology
Enzyme Immunoassay
Clinical Significance
Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of a RNA flavi
virus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
94
Dengue NS1 Antigen and Dengue Antibodies Panel (IgG & IgM) 78612
Includes
NS1 antigen; IgG, IgM antibodies
Preferred Specimen(s)
0.5 mL Serum
Transport Container
Plastic screw cap vial
Transport TemperatureRefrigerated
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyELISA
Clinical Significance
dengue hemorrhagic fever and dengue shock syndrome are caused by infection of therna flavivirus transmitted by a mosquito vector. paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
Dengue NS1 Antigen And Dengue IgM Panel 78611
Includes
NS1 antigen; IgM antibody
Preferred Specimen(s)
0.5 mL Serum
Transport Container
Plastic screw cap vial
Transport TemperatureRefrigerated
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyELISA
Clinical Significance
Dengue hemorrhagic fever and dengue shock syndrome are caused by infection of therna flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
Dengue Fever Antibody (IgG, IgM) 34301
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Received room temperature
MethodologyELISA
Clinical Significance
Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of a RNA flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection.
See Dengue Fever in the Infectious Disease section of Test Application and Interpretation.
Dengue, Antibodies Rapid Detection 79019
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated or room temperature
Reject Criteria
Received frozen
MethodologyImmunochromatography
Clinical Significance
Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of a RNA flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm diagnosis of infection.
DHEA Sulfate 402
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs) : 7 days, - 20oc, -2 months
Reject Criteria
Gross hemolysis
MethodologyChemiluminescence
Clinical Significance
DHEA-S is the sulfated form of DHEA and is the major androgen produced by the adrenal glands. This test is used in the differential diagnosis of hirsute or virilized female patients and for the diagnosis of isolated premature adrenarche and adrenal tumors. About 10% of hirsute women with Polycystic Ovarian Syndrome (PCOS) have elevated DHEA-S but normal levels of
other androgens. See Polycystic Ovary Syndrome (PCOS) in the Endocrinology section of Test Application and Interpretation.
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DHT
See “Dihydrotestosterone”
Diabetic Management Cardiac Panel C
D
78535
Includes
Glucose Fasting, Glucose Postprandial, Hemoglobin A1c, Cholesterol, Total, Cholesterol, HDL, Cholesterol, LDL (calculated if triglycerides <400 mg/dL), Triglyceride, hs CRP (High sensitivity C Reactive Protein)
Preferred Specimen(s)
5 mL whole blood in EDTA (lavender-top) tubes, 4 mL serum from a red-top tube
Transport Container
2 EDTA tubes; plastic screw-cap vial
Instructions
Fasting for at least 12 hours is required for triglycerides.
Transport TemperatureRefrigerated
Reject Criteria
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic • Frozen or stored Urine
Methodology
Spectrophotometry, Neplhometry, HPLC.
Clinical Significance
See Individual test
Diabetes Management Panel Basic (Glucose F & HbA1c) 78559
Preferred Specimen(s)
5 mL whole blood in EDTA (lavender-top) tubes, 4 mL serum from a red-top tube
Transport Container
2 EDTA tubes; plastic screw-cap vial
Instructions
Fasting for at least 12 hours is required for triglycerides.
Transport TemperatureRefrigerated
Reject Criteria
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic • Frozen or stored Urine
Methodology
Spectrophotometry, HPLC
Clinical Significance
See Individual test
Diabetic Profile Includes
Instruction
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78665
Lipid Panel, includes Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL- Cholesterol (calculated), Reflex to direct LDL-Cholesterol if Triglycerides 250 mg/dL; Glucose (fasting); Hemoglobin A1c; Creatnine Random Urine, Urea Nitrogen Random Urine 12 hour fasting required
2.0 mL Serum, 0.5 mL fasting plasma in Fluoride tube, 1.0 mL EDTA whole blood, 10.0 mL Random Urine
Plastic screw cap vial, Fluoride tube, EDTA tube, Urine Container
Serum, Fluoride tube and EDTA tube – Refrigerated, Urine – room Temperature
Grossly hemolyzed, lipemic specimens
Spectrophotometry, HPLC
See individual test for clinical Significance.
Dihydropyrimidine Dehydrogenase (DPD) Gene Mutation Analysis 15538
Preferred Specimen(s)
5 mL whole blood collected in an EDTA (lavender-top) or ACD solution B (yellow-top) tube
Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship ambient immediately. Do not freeze.
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Room temperature
Reject Criteria
Received frozen
Methodology
Polymerase Chain Reaction (PCR) • Oligonucleotide hybridizations • Chemiluminescent detection
Clinical Significance
Partial or complete deficiency of DPD activity has been associated with an increased risk for severe adverse reactions when treated with pyrimidine-based chemotherapeutic agents, such as 5-fluorouracil (5-FU). This test can also be used to confirm the clinical diagnosis
of dihydropyrimidine dehydrogenase (DPD) deficiency in affected patients and for the detection of the IVS14 + 1G A mutation in asymptomatic carriers.
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Dilantin®
See “Phenytoin”
See “Phenytoin, Free”
Direct Antiglobulin Test (DAT) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
5 mL EDTA (lavender-top) whole blood or ACD-A or ACD-B (yellow-top) tube
If submitted with a CBC, HBA1c or any other test requiring a lavender-top tube, please submit a separate tube for this test
EDTA (lavender-top) tube or ACD-A or ACD-B (yellowtop) tube
Room temperature
Gross hemolysis • Serum separator tube (SST®) • Received frozen • Red-top tube
Immune Agglutination
The DAT (Direct Coomb’s test) is positive if red cells have been coated, in vivo, with immunoglobulin, complement, or both. A positive result can occur in immunemediated
red cell destruction, autoimmune hemolytic anemia, a transfusion reaction or in patients receiving certain drugs.
Direct LDL Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
361
8293
1 mL serum or plasma from EDTA (lavender-top) tube
Plastic screw-cap vial
Ambient 5 days, Refrigerated 5 days
Gross hemolysis • Citrate containing anticoagulants
Immunoseparation, Spectrophotometry
LDL cholesterol is a key factor in the pathogenesis of atherosclerosis and Coronary Artery Disease (CAD), while HDL cholesterol has often been observed to have a protective effect. Even within the normal range of total cholesterol concentrations, an increase in LDL cholesterol can produce an associated increased risk for CAD. LDL cholesterol binds to receptor sites on macrophages in blood vessel walls inciting several changes to the blood wall which enhance atherosclerotic plaque development.
See Markers of Lipidemia in the Cardiovascular section of Test Application and Interpretation.
DNA (ds) Antibodies 255
Patient Preparation
Overnight fasting is preferred
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 24 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyELISA
Clinical Significance
High levels of antibody to double stranded DNA are found in active systemic lupus erythematosus, but are uncommon in other autoimmune diseases
DOC
See “Deoxycorticosterone”
Drug Panel 5
Includes
Preferred Specimen(s)
Instruction Transport Temperature
Reject Criteria Methodology Clinical Significance 78614
Amphetamine, Cocaine, Marijuana Metabolites (50), Phencyclidine (PCP), Opiates
10.0 mL Urine
Collect urine sample without preservative
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
See individual test for clinical significance
97
C
D
Drug Panel 6
78615
Includes
Amphetamine, Cocaine, Marijuana Metabolites (50), Phencyclidine (PCP), Propoxyphene, Opiates
Preferred Specimen(s)
10.0 mL Urine
Instruction Collect urine sample without preservative
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria Sample coating preservative
Methodology Enzyme Immunoassay
Clinical Significance See individual test for clinical significance
E
F
Drug Panel 7
Includes
Preferred Specimen(s)
Instruction Transport Temperature
Reject Criteria Methodology Clinical Significance Drug Panel 9 Includes
Preferred Specimen(s)
Instruction
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Drug Panel 10
Includes
Preferred Specimen(s)
Instruction Transport Temperature
Reject Criteria Methodology Clinical Significance Drug Panel 11 Includes
Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
98
78616
Amphetamine, Barbiturates, Cocaine, Marijuana Metabolites (50), Phencyclidine (PCP), Pro
poxyphene, Opiates
10.0 mL Urine
Collect urine sample without preservative
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
See individual test for clinical significance
78617
Amphetamine, Cocaine, Cannabinoids (THC), Phencyclidine (PCP), Propoxyphen, Opiates, Barbiturates, Benzodiazepine, Methadone
10.0 mL Urine
Collect urine sample without preservative
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
See individual test for clinical significance
79812
Amphetamine, Cocaine, Methadone, Methaqualone, Cannabinoids (THC), Phencyclidine (PCP), Propoxyphene, Opiates, Barbiturates, Benzodiazepine
10.0 mL Urine
Collect urine sample without preservative
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
See individual test for clinical significance
78623
Amphetamine, Cocaine, Methadone, Methaqualone, Cannabinoids (THC), Phencyclidine (PCP), Propoxyphen, Opiates, Barbiturates, Benzodiazepine, Ethanol
10.0 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
See individual test for clinical significance
EBV
See “Epstein-Barr Virus testing”
Electrolyte Panel Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
34392
Carbon Dioxide, Chloride, Potassium, Sodium
2 mL serum
Plastic screw-cap vial
Room temperature
Gross hemolysis • Plasma
See individual tests
See individual tests
E
F
Electrophoresis, Urine
See “Protein Electrophoresis, 24-Hour Urine (UPEP)”
ENA Antibodies
See “Sm and Sm/RNP Antibodies”
Entamoeba Antibodies
See “Entamoeba histolytica Antibody, IgG, EIA”
Entamoeba histolytica Antibody, IgG, EIA 30262
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Plasma
MethodologyELISA
Clinical Significance
Entamoeba histolytica is a parasitic protozoan that can infect the digestive tract and occasionally other tissues. Antibody IgG is useful in differentiating amebiasis from other causes of liver cysts and parasitic infection.
Entamoeba histolytica Antigen, EIA 34964
Preferred Specimen(s)
Fresh stool
Transport Temperature
Refrigerated: 24 hrs, -20oC Long term
Frozen: 1 year
MethodologyEIA
ERA/PRA
See “ER/PR Receptor, Paraffin Block, Immunohistochemical”
Estrogen and progesterone receptor assays are routinely performed on breast carcinomas to assess responsiveness to endocrine therapy and prognosis.
99
Erythrocyte Sedimentation Rate (ESR) E
F
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79930
3 mL of EDTA whole blood or 3 ml whole blood 3.2% sodium citrate
Ship samples to laboratory immediately upon collection
EDTA vial (Lavender top) or Sodium citrate vial (black top tube)
Room temperature or Refrigerated
Received frozen
Westergren Method
The erythrocyte sedimentation rate (ESR), also called a “sedimentation rate,” “sed rate” or ”Biernacki Reaction,” is a non-specific measure of inflammation that is commonly used as a medical screening test. The ESR is increased by any cause or focus of inflammation. The
ESR is decreased in sickle cell anemia, polycythemia, and congestive heart failure. The basal ESR is slightly higher in females.
ESR testing should be performed within 12 hours of specimen collection. A better alternative acute inflammatory marker is C reactive Protein (CRP).
Enhanced Estradiol (eE2) 15577
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic screw cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyChemiluminescence
Clinical Significance
Estradiol is the major estrogenic hormone secreted by the ovaries. Measurement of estradiol may be useful in women to assess ovarian function in patients with menstrual disorders, precocious or delayed puberty, and menopause and useful in men to assess gynecomastia.
Eosinophil Count, Absolute Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
425
Whole blood full EDTA (lavender-top) tube
Maintain specimen at room temperature. If multiple draw, collect EDTA (lavender-top) tube last. Traumatic tap can introduce thromboplastin and trap WBC and platelets. Refrigeration can precipitate fibrin and trap WBC and platelets. Do not refrigerate.
EDTA (lavender-top) tube
Room temperature
Hemolysis • Clotted • Received frozen
Electronic Cell Sizing, Sorting/Cytometry/Microscopy
Estriol, Unconjugated (uE3) 434
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic screw cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyChemiluminescence
Clinical Significance
Much of Estradiol is bound to proteins. The unbound portion and Estradiol bound to proteins with low affinity reflect the Free concentration. The Free Estradiol may better correlate with medical conditions than the Total Estradiol concentrations.
Factor V Activity 79347
Preferred Specimen(s)
1.0 mL Citrate Plasma
Instruction
Give detail of Oral Anticoagulant Therapy
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyCoagulation
Clinical Significance
This test is useful to evaluate a prolonged PT. Deficiency is associated with bleeding risk.
100
Factor V (Leiden) Mutation Analysis 17900
Preferred Specimen(s)
5 mL whole blood, EDTA (lavender-top) tube
Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received frozen
Methodology
Polymerase Chain Reaction (PCR), Oligonucleotide Ligation Assay, Fluorescent Microspheres
Clinical Significance
Factor V (Leiden) Mutation is a point mutation that causes resistance of Factor V protein degradation by activated protein C (APC). This mutation is associated with increased risk of venous thrombosis.
Factor V HR2 Allele DNA Mutation Analysis 17902
Preferred Specimen(s)
5 mL whole blood EDTA (lavender-top) preferred
Instructions
Forward tissue specimens immediately to the Molecular Genetics Laboratory; do not hold.
Whole Blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
For prenatal diagnosis with a fetal specimen:
1) parents must be documented carriers of one of the mutations tested;
2) maternal blood or DNA must be available;
3) contact the laboratory genetic counselor before submission. Amniotic fluid: Normal collection procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not refrigerate or freeze. Amniotic culture: Sterile T25 flask, filled with culture medium. Specimen stability is crucial. Store and ship room temperature immediately. Do not refrigerate or freeze. Dissected chorionic villus (CVS) biopsy: 10-20 mg dissected chorionic villi collected in sterile tube filled with sterile culture media. Specimen stability is crucial. Store and ship room temperature immediately. Do not refrigerate or freeze. Please indicate the ethnicity of the patient. Do not hold cells; forward to laboratory when cells arrive.
Transport TemperatureFrozen
Reject Criteria
Frozen samples • Exceeds specimen stability • Wrong specimen type
Methodology
Polymerase Chain Reaction (PCR), Oligonucleotide Ligation Assay,
Fluorescent Microspheres
Clinical Significance
Factor V HR2 Allele, DNA Mutation Analysis is useful in patients who are carriers of Factor V Mutation (Leiden). Coinheritance ofFactor V Mutation (Leiden) is associated with a 3-4-
fold increased risk of venous thrombosis compared to inheritance of Factor V Mutation (Leiden) alone.
Factor VII 79113
Preferred Specimen(s)
1.0 mL Citrate Plasma
Instruction
Give detail of Oral Anticoagulant Therapy
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyCoagulation
Clinical Significance
This test is useful to evaluate a prolonged PT. Deficiency is associated with bleeding risk.
Factor VIII Activity, Clotting 347
Preferred Specimen(s)
1.0 mL Citrate Plasma
Instruction
Give detail of Oral Anticoagulant Therapy
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyCoagulation
Clinical Significance
This test is useful to evaluate a prolonged aPTT. The most common form of hemophilia is caused by deficiency of factor VIII. Hemophilia A is an x-linked disorder affecting between 1 in 5,000 to 10,000 males.
101
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F
Factor X, Activity 79112
Preferred Specimen(s)
1.0mL Citrate Plasma
Instruction
Give detail of Oral Anticoagulant Therapy
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject Criteria
Grossly hemolyzed, lipemic specimens
MethodologyCoagulation
Clinical Significance
This test is useful to evaluate a prolonged PT.
Factor XIII Activity E
F
14461
Preferred Specimen(s)
1 mL citrated plasma
Instructions
Freeze immediately after separating from cells. Do not thaw.
Transport Container
Plastic screw vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature or refrigerated; hemolysis; lipemia
MethodologyChromogenic
Clinical Significance
Low Factor XIII levels, i.e., <15%, may cause a bleeding disorder and levels <2% have been associated with spontaneous intracranial hemorrhage.
Ferritin 457
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
Reject Criteria
Plasma • Gross hemolysis
MethodologyChemiluminescence
Clinical Significance
Useful in the diagnosis of hypochromic, microcytic anemias. Decreased in iron deficiency anemia and increased in iron overload.
Fibrinogen Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
461
3.2% sodium citrate (light blue-top) tube
Correct ratio of blood to citrate is critical. Do not overfill or underfill collection tube. Mix by inversion 4 times. Do not pool plasma from multiple tubes. For nonheparinized patients, maintain specimen at room temperature. Do not uncap. Non-heparinized patients are stable up to 72 hours at room temperature. Heparinized patients stable for 24 hours at room temperature. If testing cannot be completed within stability limits, centrifuge specimen within 1 hour of collection at least 1500 RCF (relative centrifugal force) for 15 minutes. Transfer plasma to a plastic screw-cap vial and freeze at -200 C immediately.
Whole blood: 3.2% sodium citrate (light blue-top) tube
Plasma: Plastic screw-cap vial (frozen)
Room temperature for light blue-top (sodium citrate) tube; frozen for plasma in plastic screw-cap vials
Hemolysis • Clotted
Cloth Detection
Fibrinogen is essential for the formation of a blood clot. Deficiency can produce mild to severe bleeding disorders.
See Non-Lipid Markers of Cardiovascular Disease in the Cardiovascular chapter of Test Application and Interpretation.
Fibrinogen Degradation Product (FDP) Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
102
458
1 mL citrated plasma
Plastic screw cap vial
Frozen, stable 1 month
Latex Agglutination
Bleeding disorders may be due to inherited or acquired deficiencies of a clotting factor. Filariasis, Blood
See “Malaria Blood Parasites”
First Trimester Screening With NT Value 79223
Preferred Specimen(s)
2mL Serum
Transport Container
Red top tube or SST or Plastic screw cap tube
Transport Temperature
Refrigerated (2-8°C) - 24 hrs; Frozen - 20°C - 2 months
Reject Criteria
EDTA Plasma, Hemolyzed, Lipemic and icteric specimens not acceptable.
MethodologyChemiluminescene
Clinical Significance
Maternal serum PAPP-A and free beta HCG assessment between 11 and 14 weeks of pregnancy is reported to have significant utility in screening & Down syndrome and other chromosomal abnormalities. A combination of maternal age related risk, Free beta - HCG & fetal nuchal translucency (NT) measurements might substantially increase the efficiency of prenatal screening.
First Trimester Screening Without NT Value 79221
Preferred Specimen(s)Serum
Transport Container
Red top tube or SST or Plastic screw cap tube
Transport Temperature
Refrigerated (2-8°C) - 24 hrs; Frozen - 20°C - 2 months
Reject Criteria
EDTA Plasma, Hemolyzed, Lipemic and icteric specimens not acceptable.
MethodologyChemiluminescene
Clinical Significance
Maternal serum PAPP-A and free beta HCG assessment between 11 and 14 weeks of pregnancy is reported to have significant utility in screening & Down syndrome and other chromosomal abnormalities. A combination of maternal age related risk, Free beta - HCG & fetal nuchal translucency (NT) measurements might substantially increase the efficiency of prenatal screening.
FISH TEL/AML 1 assay 14644
Preferred Specimen(s)
3 - 4 ml Whole Blood (Min2 - 3 ml) Green Top Sodium Heparin Tube (Random); Room Temperature;
-OR
3 mL Bone Marrow (Min1 mL) in Transport Media or Green Top Sodium Heparin Tube (Random); Room Temperature;
Instructions
Clinical history and reason for referral are required with test order. Prior therapy/transplant information should be submitted with test order. This FISH (fluorescence in situ hybridization) procedure is used to detect the TEL/AML1 gene fusion resulting from a cytogenetically undetectable t(12;21)(p13;q22) translocation, which is common in pediatric pre B-ALL. This test is useful for the evaluation of suboptimal specimens, cases with a normal karyotype, or when an abnormal karyotype lacking a specific/prognostically defined abnormality or
demonstrating deletion 12p is found. Bone marrow transport medium is available upon request. Instructions, Specimen stability/rejection requirements: Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination.
Do not reject.
Transport Container
Culture Transport Media
Transport Temperature
Room Temperature
Reject Criteria
Frozen; Clotted; Hemolysed
Methodology
Fluorescence In Situ Hybridization
Clinical Significance
Cryptic translocation undetectable by routine cytogenetic analysis, present in approximately 30% of precursor B-cell acute lymphoblastic leukemia and associated with favorable prognosis.
FISH PML/RARA Assay Preferred Specimen(s)
14643
3 - 4 mL Whole Blood (Min3 mL) Green Top Sodium Heparin Tube (Random); Room Temperature;
103
E
F
E
F
-OR
3 mL Bone Marrow (Min1 mL) in Transport Media or Green Top Sodium Heparin Tube (Random); Room Temperature;
Instructions
Clinical history and reason for referral are required with test order. Prior therapy/transplant history should be submitted with test order. This test is performed to detect the PML/RARA molecular rearrangement by FISH (fluorescence in situ hybridization). Bone marrow transport medium is available upon request. Instructions, Specimen stability/rejection Requirements: Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not reject.
Transport Container
Culture Transport Media
Transport Temperature
Room Temperature
Specimen Stability
Room Temperature: See instruction
Refrigerated: See instruction
Reject Criteria
Frozen; Clotted; Hemolysed
Methodology
Fluorescence In Situ Hybridization
Clinical Significance
To rule out the presence of a PML/RARA rearrangement specific for acute promyelocytic leukemia (APML).
FISH ETO/AML1 Assay 14640
Preferred Specimen(s)
3 mL Bone Marrow (Min 1 mL) in Transport Media or Green Top Sodium Heparin Tube (Random); Room Temperature;
-OR
3 - 4 mL Whole Blood (Min 1 mL) Green Top Sodium Heparin Tube (Random); Room Temperature;
Instructions
Clinical history and reason for referral are required with test order. Prior therapy/transplant information should be submitted with test order. This test is useful for detecting cell populations that may not be mitotically active, that have suboptimal chromosome morphology, or that have variant or cryptic rearrangements. Bone marrow transport medium is available upon request. Instructions, Specimen stability/rejection Requirements: Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not reject.
Transport Container
Culture Transport Media
Transport Temperature
Room Temperature
Reject Criteria
Frozen; Clotted; Hemolysed
Methodology
Fluorescence In Situ Hybridization
Clinical Significance
The (8:21) translocation is the most frequently observed karyotypic abnormality associated with acute myeloid leukemia (AML), subtype M2. Patients with this type of
AML have a high remission rate with conventional chemotherapy.
FISH, EGFR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Methodology
Clinical Significance
19041
Formalin fixed paraffin embedded tissue
Formalin fixed, paraffin embedded human tissue specimen.
Formalin fixed paraffin embedded tissue block
Room temperature
Fluorescence In-Situ Hybridization (FISH)
The epidermal growth factor receptor (EGFR) is a cellular transmembrane receptor with tyrosine kinase enzymatic activity that plays a key role in human cancer. EGFR-dependent signaling is involved in cancer cell proliferation, apoptosis, angiogenesis, invasion and
metastasis. Targeting the EGFR is a valuable molecular approach in cancer therapy.
FISH, HER-2/neu, Paraffin Block Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
104
14620
Breast tissue biopsy, formalin fixed paraffin-embedded block Pathology report or pathologic diagnosis must be included with IHC score for ER, PR & HER-2/neu findings
Sterile screw-cap vial or paraffin block bag
Room temperature
Fluorescence in situ Hybridization (FISH)
HER-2 oncogene amplification in stage 2 lymph node positive breast cancer which aids in treatment selection and prognostication See FISH, HER-2/neu, Paraffin Block in the Hematology/Oncology section of Test Application and Interpretation
Flow Surface Light Chains, Flow Cytometry 11015
Includes
Kappa and Lambda Light Chains
Preferred Specimen(s)
5 mL whole blood, bone marrow or tissue/fluid collected into a sodium heparin (green-top) tube
Instructions
Submit Sodium Heparin (green-top) tube whole blood or 2 mL heparinized bone marrow. A freshly prepared smear (stained or unstained) is also recommended. A clinical summary or differential diagnosis is required along with specimen OR place a representative portion of fresh tissue (0.5 cm square) in sterile tissue culture medium such as RPM1-1640 in a sterile container. Alternatively, place the tissue on a saline-soaked gauze pad in a sealed specimen cup and ship refrigerated. Do not suspend the tissue in saline. Please submit stained H & E slide, a copy of the pathology report and a brief clinical summary.
Transport Container
Sodium heparin (green-top) tube
Transport Temperature
Blood/Bone Marrow: Room temperature
Tissue/Fluid: Refrigerated (cold packs)
Reject Criteria
Received frozen • Fixed sample
Methodology
Flow Cytometry
Clinical Significance
The presence of immunoglobulin light chains (kappa or lambda) on the cell surface is characteristic of clonal proliferation most often seen in multiple myeloma and lymphoproliferative diseases
Flow ONTAK® Sensitivity (CD25) 11237
Preferred Specimen(s)
5 mL whole blood or bone marrow collected in a (greentop) sodium heparin tube
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
Reject CriteriaFrozen
Methodology
Flow Cytometry
Clinical Significance
ONTAK® is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) with malignant cells that express CD25. Pretreatment testing to establish CD25 sensitivity is available.
See Hematopoietic/Lymphoid Disorders in the Hematology/Oncology section of Test Application and Interpretation.
Flow NK Cells (CD3/CD45/CD16+CD 56/CD19) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1.0 mL Whole Blood in EDTA (lavender top) Vial
Do not freeze.
Submit the EDTA tubes at room temperature.
Collection Tube
Room Temperature
Hemolyzed, Whole blood received frozen
Flow Cytometry
This test measures Natural Killer cells. Measurement of NK cells is useful in the diagnosis of retinoblastomas, medullblastomas, astrocytomas, and neuroblastomas.
Flow Lymphocte Subset CD3% (Flow Cytometry) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
14798
19913
5 mL whole blood collected in an EDTA (lavender-top) tube
Specimens are stable for 48 to 72 hours at room temperature. If a CBC is also required, a separate EDTA (lavender-top) tube must be submitted.
5 mL (or 3 mL pediatric) EDTA (lavender-top) tube
Room temperature
Hemolysis • Clotted • Frozen
Flow Cytometry
CD3 is a cell surface marker on lymphocyte T cell population that defines the total population of T cells. A common usage of lymphocyte characterization is to monitor patients with HIV 105
E
F
infection. The CD4:CD8 (CD3) ratio is often inverted in patients infected with HIV. These patients are at increased risk of opportunistic infections.
Flow Lymphocte Subset CD4% (Flow Cytometry) E
F
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
5 mL whole blood collected in an EDTA (lavender-top) tube
Specimens are stable for 48 to 72 hours at room temperature. If a CBC is also required, a separate EDTA (lavender-top) tube must be submitted.
5 mL (or 3 mL pediatric) EDTA (lavender-top) tube
Room temperature
Hemolysis • Clotted • Frozen
Flow Cytometry
CD4 is a cell surface marker on lymphocyte T cell population that defines the subpopulation of T helper cells. A common usage is to monitor patients with HIV infection since CD4 cell population is down-regulated during disease progression. The CD4:CD8 (CD3) ratio is
often inverted in patients infected with HIV. These patients are at increased risk of opportunistic infections.
Flow Lymphocte Subset CD8% (Flow Cytometry) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
14804
19914
5 mL whole blood collected in an EDTA (lavender-top) tube
Specimens are stable for 48 to 72 hours at room temperature. If a CBC is also required, a separate EDTA (lavender-top) tube must be submitted.
5 mL (or 3 mL pediatric) EDTA (lavender-top) tube
Room temperature
Hemolysis • Clotted • Frozen
Flow Cytometry
CD8 is a cell surface marker on lymphocyte T cell population that defines the subpopulation of T suppressor cells. A common usage is to monitor patients with HIV infection. The CD4: CD8 (CD3) ratio is often inverted in patients infected with HIV. These patients are at increased risk of opportunistic infections.
Fluid Analysis, Ascitic Fluid 78549
Includes
Biochemistry, Cell count
Preferred Specimen(s)
2 ml ascitic fluid
Transport Container
Plastic screw-cap container/EDTA tube
Transport TemperatureRefrigerated
Reject Criteria
Gel barrier tube; frozen
Methodology
PAP stain, Geimsa stain, Microscopic examination
Clinical Significance
Fluid analysis is useful to describe the cause of fluid accumulation, i.e., transudate, exudate, hemorrhage, or effusion. Ascites fluid may be secondary to malignancy even with negative cytological exam.
Fluid Analysis, Pericardial Fluid 78551
Includes
Biochemistry, Cell count
Preferred Specimen(s)
3 ml pericardial fluid
Instructions
Grossly hemolyzed specimens are unacceptable. Freeze immediately after collection.
Transport Container
Sterile, screw-cap container/EDTA tube
Transport TemperatureRefrigerated
Reject Criteria
Gel barrier tube, received at room temperature; frozen
Methodology
PAP stain, Geimsa stain, Microscopic examination
Clinical Significance
Fluid analysis is useful to describe the cause of fluid accumulation, i.e., transudate, exudate, hemorrhage, or effusion. Abnormal pericardial fluid analysis may suggest infection, inflammation, cardiac trauma, or tumor.
106
Fluid Analysis, Pleural Fluid 78552
Includes
Biochemistry, Cell count
Preferred Specimen(s)
2 ml pleural fluid
Instructions
Avoid hemolysis
Transport Container
Sterile, screw cap container/EDTA tube
Transport TemperatureRefrigerated
Reject Criteria
Gel barrier tube, received at room temperature; Frozen
Methodology
PAP stain, Geimsa stain, Microscopic examination
Clinical Significance
Fluid analysis is useful to describe the cause of fluid accumulation, i.e., transudate, exudate, hemorrhage, or effusion. Abnormal pleural fluid analysis may suggest infection including tuberculosis, congestive heart failure, cirrhosis, nephritis, injury such as perforation, and tumor.
Fluid Analysis, Synovial Fluid 78553
Includes
Cytology, Biochemistry, Cell count
Preferred Specimen(s)
2 ml synovial fluid
Transport Container
Sterile plastic transport tube
Transport TemperatureRefrigerated
Reject Criteria
Gel barrier tube, frozen
Methodology
PAP stain, Geimsa stain, Microscopic examination
Clinical Significance
Fluid analysis is useful to describe the cause of the fluid accumulation. Abnormal synovial fluid analysis is associated with gout, rheumatoid arthritis, septic arthritis, traumatic arthritis, and infections.
Free ß-hCG Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79620
1.0 mL Serum
Plastic screw cap vial
Refrigerated, stable 7 day’s
Grossly hemolyzed, lipemic specimens
Chemiluminescent Enzyme Immunoassay
Maternal serum free Beta HCG assessment is reported to have significant utility in first & second trimester prenatal screening for Down syndrome & other chromosomal anomalies. A first trimester combination of maternal age, serum PAPP-A & fetal nuchal translucency (NT) measurements might substantially increase the efficiency of the prenatal screening compared to second trimester screening; using this approach, various investigator have reported detection rates for Down syndrome of 85 to 90 percent at a 5% false positive rate.
FOBT
See “Fecal Globin by Immunochemistry (InSure®)”
Folate, Serum 466
Preferred Specimen(s)
1 mL serum
Instructions
Folate is light sensitive. Minimize exposure to light during sample handling and storage.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stable 5 day’s
Reject CriteriaHemolysis
MethodologyChemiluminescence
Clinical Significance
Folic acid deficiency is common in pregnant women, alcoholics, in patients whose diets do not include raw fruits and vegetables, and in people with structural damage to the small intestine. The most reliable and direct method of diagnosing folate deficiency is the
determination of folate levels in both erythrocytes and serum. Low folic acid levels, however, can also be the result of a primary vitamin B12 deficiency that decreases the ability of cells to take up folic acid.
Folic Acid
107
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See “Folate, Serum”
Follicular Lymphoma, bcl-2/JH t(14;18),
Real-Time PCR, Plasma-Based G
H
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
17690
3 mL EDTA (lavender-top tube) whole blood
Submission of whole blood: Follow standard whole blood collection procedure. Collect 3-5mL whole blood samples in an EDTA tube. Blood samples are shipped at room temperature or 4°C. Do not freeze whole blood. Record the draw time and the date on the tube. Ship immediately to maintain sample stability. Submission of plasma: Collect blood in a sterile tube containing EDTA anticoagulant (lavender-top). Separate plasma from the cellsy centrifugation within 2 hours after collection at least 1250 RCF (relative centrifugal force) for 15 minutes, transfer the plasma to a separate plastic screw-cap vial, and ship frozen. Note: Information regarding draw time and date is required to ensure stability of the sample is maintained.
EDTA (lavender-top) tube
Refrigerated (cold packs) 5 days
Gross hemolysis • Received frozen blood samples • Received clotted blood samples
Real-Time Polymerase Chain Reaction, (RT-PCR)
The plasma based molecular assay is based on the concept that in hematological diseases, tumor cells pour their DNA and RNA into the circulation. These components can be detected in plasma, and can replace the routine painful bone marrow aspiration or biopsy procedure. The presence of the bcl-2 translocation has been associated with poor prognosis in one
group of diffuse large-cell and follicular lymphoma patients. Analysis of bcl-2 translocation also provides an important marker for detection and of monitoring of malignancy during patient treatment and follow-up.
Fructosamine 8340
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial or spun barrier tube
Transport Temperature
Refrigerated 2 weeks
Reject Criteria
Hemolysis • Moderate or grossly icteric
MethodologyColorimetry
Clinical Significance
The fructosamine assay is useful in monitoring the degree of glycemia over short-to-
intermediate time frames (1-3 weeks). A fructosamine concentration greater than the established normal range is an indication of prolonged hyperglycemia of 1-3 weeks or longer.
The higher the fructosamine value, the poorer the degree of glycemic control.
FSH (Follicle Stimulating Hormone) 470
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Stable 7 days, Refrigerated 14 days
MethodologyChemiluminescence
Clinical Significance
This test is useful in the differential diagnosis of pituitary and gonadal insufficiency and in children with precocious puberty
FT4
See “T4 Free (FT4)”
Fungus Culture, Blood
See “Culture, Blood”
Fungus, Direct Examination, Skin, Hair or Nails Preferred Specimen(s)
108
Skin, hair, or nails
14824
Transport Container
Sterile screw-cap container
Transport Temperature
Room temperature 2 weeks
Reject Criteria
Received frozen
Methodology
Fluroscent Microscopic
Clinical Significance
Tissues containing keratin (skin, hair, and nails) can become infected with dermatophytes. These superficial fungal infections range in severity. Proper diagnosis can guide selection of therapy.
G-6-PD
See “Glucose-6-Phosphate Dehydrogenase, Quantitative”
Gamma Glutamyl Transferase (GGT) 482
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 2 weeks
Reject Criteria
Hemolysis • Plasma
MethodologySpectrophotometry
Clinical Significance
Elevated GGT is found in all forms of liver disease. Measurement of GGT is used in the diagnosis and treatment of alcoholic cirrhosis, as well as primary and secondary liver tumors. It is moresensitive than alkaline phosphatase, the transaminases, and leucine aminopeptidase
in detecting obstructive jaundice, cholangitis, and cholecystitis. Normal levels of GGT are seen in skeletal diseases; thus, GGT in serum can be used to ascertain whether a disease, suggested by elevated alkaline phosphatase, is skeletal or hepatobiliary.
Genotype MTbDR Panel 79554
Includes
MTb Rapid RIF/INH sens. assay and Genotype MTb second line (Aminoglycosides and Flouroquinolones)
79552 - MTb Rapid RIF/INH sens. assay
79553 - Genotype MTb second line
See individual test for details
GGT
See “Gamma Glutamyl Transferase (GGT)”
Gliadin Antibody (IgA) 11228
Preferred Specimen(s)
1 mL serum
Instructions
Avoid lipemia
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 48 hrs, Ambient 8 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Lipemia
MethodologyELISA
Clinical Significance
See Gliadin Antibody Panel (IgA, IgG) in the Immunology section of Test Application and Interpretation.
Gliadin Antibody (IgG) 11212
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 48 hrs, Ambient 8 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Gross Lipemia • Plasma
MethodologyELISA
Clinical Significance
Celiac Disease is characterized by the presence of Gliadin Antibody. Such patients display a hypersensitivity to gluten (wheat) in their diet. The antibody is undetectable when patients with hypersensitivity are placed on gluten-free diets. Antibody IgA is more specific and IgG
109
G
H
is a more sensitive assay to Celiac Disease. See Gliadin Antibody Panel (IgA, IgG) in the Immunology section of Test Application and Interpretation.
Glucose G
H
Patient Preparation
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
483
Patient should fast for 8 hours
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Unspun SST • Red-top or non-plasma separator (PST) green-top tubes • Anticoagulants other than litium heparin, sodium heparin or fluoride/oxalate
Spectrophotometry (SP)
Serum glucose levels may be abnormally high (hyperglycemia) or abnormally low (hypoglycemia). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolic disorders including diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell neoplasm.
See Diabetes in the Endocrinology section of Test Application and Interpretation.
Glucose, Random (Plasma) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
8917
1 mL plasma collected in a Fluoride/EDTA Tube
Plastic Screw cap vial
Ambient 5 days, Refrigerated 2 weeks
Unspun sst, red-top or non-plasma separator (pst) green-top tubes. Anticoagulants other than lithium heparin, sodium heparin or fluoride/oxalate.
Spectrophotometry (SP)
Plasma glucose levels may be abnormally high (hyperglycemia) or abnormally low (hypoglycemia). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolic disorders including diabetes mellitus, idiopathic hypoglycemia,
and pancreatic islet cell neoplasm.
Glucose Tolerance Test, 3 serum specimens (75g) 23475
Includes
Fasting, 1-Hour, 2-Hour glucose
Patient Preparation
Fasting required. Fasting is defined as no consumption of food or beverage other than water for at least 8 hours before testing.
Preferred Specimen(s)
Three - 1 mL plasma specimens collected in fluoride/EDTA Tubes
Instructions
Immediately after a fasting specimen is obtained, have patient ingest a 75 g load of glucose. Draw subsequent specimens 1 and 2 hours later. Label each with the specific draw time. For children, the glucose load is 1.75 g glucose per kg ideal body weight, up to 75 g
(pounds/2.2 = kilograms). See table below.
Weight of Patient (kg) g of glucose
10.9-14.9 22.5
15.0-19.4 30.0
19.5-23.5 37.5
23.6-28.1 45.0
28.2-32.2 52.5
32.3-36.7 60.0
36.8-40.8 67.5
>40.8 75.0
Transport Container
Plastic screw-cap vials
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Serum • Anticoagulants other than fluoride/ oxalate
MethodologyHexokinase
Clinical Significance
This test is used for the routine diagnosis of diabetes in children and the non-pregnant adult. For pregnant females see test “Glucose Tolerance Test, Gestational, 4 Specimens (100 g)”. For appropriate interpretation of this test, the patient must fast overnight and ingest a 75 g load of glucose. Immediately after, a fasting specimen is obtained. For children, the glucose
load is 1.75 g/Kg of body weight, up to 75. The diagnosis of diabetes is made if the fasting glucose is .126 mg/dL or if the 2-hour specimen is .200 mg/dL.
110
Glucose, Fasting & Post Prandial Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1.0 mL plasma after 12 hour fasting and 1.0 mL plasma post 2 hours of breakfast in Fluoride/
EDTA Tube
Patient should fast for 8 hours
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Unspun SST • Red-top or non-plasma separator (PST) green-top tubes • Anticoagulants other than litium heparin, sodium heparin or fluoride/oxalate
Spectrophotometry (SP)
Diagnosis of diabetes mellitus and evaluation of carbohydrate metabolism.
Glucose, Fasting (Plasma) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
6881
484
1.0 mL plasma after 12 hrs Fasting in Fluoride/EDTA Tube
Patient should fast for 8 hours
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Unspun SST • Red-top or non-plasma separator (PST) green-top tubes • Anticoagulants other than litium heparin, sodium heparin or fluoride/oxalate
Spectrophotometry (SP)
Diagnosis of diabetes mellitus and evaluation of carbohydrate metabolism.
Glucose 6 Phosphate Dehydrogenase (G-6-PD) Activity Blood (Quantitative) 78024
Preferred Specimen(s)
1.0 mL whole blood collected in an EDTA (lavender-top) tube
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Refrigerated (cold packs) 7 days
Reject Criteria
Received frozen, grossly hemolysed
MethodologySpectrophotometry
Clinical Significance
G-6-PD is the most common enzyme deficiency in the world. Newborns with G-6-PD may have prolonged and more pronounced neonatal jaundice than other newborns. Older individuals are subject to hemolytic anemia that can be induced by some foods, drugs, and infections.
Glucose Tolerance Test, Gestational, 4 Specimens (100mg) Includes
Patient Preparation
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Fasting, 1-Hour, 2-Hour, 3-Hour glucose
Fasting required. Fasting is defined as no consumption of food or beverage other than water for at least 8 hours before testing.
Four-1 mL plasma specimens collected in fluoride/EDTA Tubes
Immediately after a fasting specimen is obtained, have patient ingest a 100 g load of glucose. Draw subsequent specimens 1, 2 and 3 hours later. Label each with the specific draw time.
Plastic screw-cap vials
Ambient 5 days, Refrigerated 14 days
Gross hemolysis • Serum • Anticoagulants other than fluoride/ oxalate
Spectrophotometry (SP)
Plasma glucose levels may be abnormally high (hyperglycemia) or abnormally low (hypoglycemia). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolic disorders.
Glucose, Gestational Screen (50g) Patient Preparation
Preferred Specimen(s)
Instructions
Transport Container
6745
8477
The patient is given a 50 gram dose of glucose and a single blood specimen is obtained one hour later. Fasting is not required.
1 mL plasma collected in a fluoride/EDTA Tube
The patient is given a 50 gram dose of glucose and a single blood specimen is obtained one hour later. Fasting is not required. Note: The test should be performed between weeks 24 and 28 of gestation.
Fluoride/EDTA Tube or plastic screw-cap vial
111
G
H
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Anticoagulants other than fluoride/oxalate • Serum
MethodologyHexokinase
Clinical Significance
A value of 130 mg/dL or greater indicates the need for a full diagnostic, gestational glucose tolerance performed in the fasting state to determine if the patient has gestational diabetes.
Glucose, Postprandial 78005
Preferred Specimen(s)
1 ml plasma NaF
Instructions
Sample should be collected 2 hours after meal
Transport Container
Plastic screw cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Received room temperature
MethodologySpectrophotometry
Clinical Significance
Postprandial glucose may be useful in evaluating diabetes mellitus and carbohydrate metabolism.
G
H
Gram Stain 497
Preferred Specimen(s)
Swabs, sputum, bronchial washing, body fluids, urine, tissue
Instructions
Collect using sterile technique
Transport Container
Bacterial transport tube, sterile screw cap container, or transport tube with preservative (for urine)
Transport Temperature
Room termperature : 10 days for dried smear and 2 days for specimen swab
Refrigerated : Respiratory specimen and body fluids are stable upto 24 hrs & 48 hrs,
respectively
Reject Criteria
Received at room temperature; Frozen
Methodology
Microscopic Examination
Clinical Significance
The Gram Stain is a rapid, preliminary test to identify bacterial infections and to guide initial antibacterial therapy.
Growth Hormone Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
521
1.0 mL Serum
Patient should be fasting and at complete rest 30 minutes before blood collection.
Plastic screw cap vial
Refrigerated (Stability 7 days)
Grossly hemolyzed, lipemic specimens
Chemiluminescent Enzyme Immunoassay
Measurement of GH is primarily of interest in the diagnosis and treatment of various forms of inappropriate growth hormone secretion. Growth hormone measurements in children are used in the evaluation of short stature and help differentiate low GH production from other sources of growth failure. Stimulation and suppression tests are often more meaningful than
random measurements.
Haptoglobin Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
502
1 mL serum
Plastic screw-cap vial
Refrigerated 7 days
Hemolysis • Hyperlipemia
Nephelometry
Decreased haptoglobin is found in hemolytic disease, hepatocellular disease and infectious mononucleosis. Increased level is found in inflammatory disease in the presence of tissue necrosis and in general acute inflammatory conditions.
Haemoglobin and Hematocrit Panel 112
7998
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
3 ml whole blood in EDTA vial (lavender-top tube)
EDTA vial (lavender-top) tube
Room temperature
Received frozen
Methemoglobin
An automated blood analysis provides insights into medical conditions associated with changes in red blood cells, e.g., polycythemia vera and anemias.
HBe Antigen
See “Hepatitis Be Antigen”
Hb Electrophoresis by Capillarys 78942
Preferred Specimen(s)
3 mL whole blood
Instruction
Overnight fasting is preferred
Transport Container
lavender top EDTA
Transport TemperatureRefrigerated
Reject Criteria
Received clotted
Methodology
Capillarys Electrophoresis
Clinical Significance
Haptoglobin binds free hemoglobin and acts as an indicator of erythrocyte destruction or hemolysis. With binding of hemoglobin, the haptoglobin complex is destroyed and concentrations are low. Haptoglobin is an acute phase reactant and elevated concentrations
are observed with inflammatory diseases.
hCG, Qualitative, Urine Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
396
10 mL urine from a first morning voided specimen
Urine Collection Container
Room temperature
Immunoblot assay
This test is specific for hCG beta subunit and offers sensitivity necessary to detect pregnancy as early as ten days post conception
hCG, Total, Quantitative 8396
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
MethodologyChemiluminescence
Clinical Significance
hCG may reach detectable limits within 7-10 days of conception. hCG is produced by the placenta and reaches a peak between the 7th and 10th week of gestation. hCG is a glycoprotein hormone produced by the syncytiotrophoblast of the placenta and secreted
during normal pregnancy and with pathologic conditions such as hydatidiform mole, choriocarcinoma and testicular neoplasm. Order hCG, Total, QL, Urine, if hCG serum result is inconsistent with clinical presentation.
HDL Cholesterol 608
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Anticoagulants other than heparin
Methodology
Spectrophotometry (SP)
Clinical Significance
HDL cholesterol is inversely related to the risk for cardiovascular disease. It increases following regular exercise, moderate alcohol consumption and with oral estrogen therapy. Decreased levels are associated with obesity, stress, cigarette smoking and diabetes mellitus.
See Markers of Lipidemia in the Cardiovascular Tests section of Test Application and Interpretation.
113
G
H
Hemoglobin A1c 496
Preferred Specimen(s)
1 mL whole blood collected in a EDTA (lavender-top) tube
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Ambient 3 days, Refrigerated 7 days
MethodologyHPLC
Clinical Significance
Assesses long term diabetic control in diabetes mellitus
See Diabetes in the Endocrinology section of Test Application and Interpretation.
Hemoglobin G
H
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
510
3 ml Whole blood full EDTA (lavender-top) tube
Maintain specimen at room temperature. If multiple draw, collect EDTA (lavender-top) tube last. Traumatic tap can introduce thromboplastin and trap WBC and platelets. Refrigeration can precipitate fibrin and trap WBC and platelets. Do not refrigerate.
EDTA (lavender-top) tube
Room temperature
Hemolysis • Clotted • Received frozen
Electronic Cell Sizing, Sorting/Cytometry/Microscopy
Usual method for determining anemia. Used to calculate indices.
Hepatic Function Panel 10256
Includes
Total Protein, Albumin, Globulin (calculated), Total Bilirubin, Direct Bilirubin, AST, ALT, LD Alkaline Phosphates, Prothrombin Time (PT-INR)
Preferred Specimen(s)
4 mL serum from a red-top tube plus 1 whole blood sodium citrate (light blue-top) tube
Transport Container
Serum Separator Tube or plastic screw-cap vial; sodium citrate (light blue-top) tube
Transport Temperature
Ambient 5 days, Refrigerated 2 weeks
Reject CriteriaHemolysis
Methodology
See individual analytes
Clinical Significance
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatic Function Panel 2 78570
Includes
Total Protein; Albumin, Globulin (calculated); Total Bilirubin; Direct Bilirubin; AST; ALT; Alkaline Phospatase; Gamma Glutamyl Transferase
Preferred Specimen(s)
4.0 mL serum from a red-top tube
Transport Container
Serum Separator Tube or plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject CriteriaHemolysis
Methodology
See individual analytes
Clinical Significance
See individual test for clinical significance
Hepatitis A Antibody, Total 508
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyImmunoassay
Clinical Significance
HAV antibody indicates prior or acute infection with, or immunization to, Hepatitis A virus.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation
Hepatitis A IgM Antibody Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 7 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
114
512
Clinical Significance
IgM antibodies to Hepatitis A suggest a current, acute or recent Hepatitis A infection.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation
Hepatitis B Core Antibody Total 37676
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 7 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
Hepatitis B core-specific IgM class antibody has been detected in most acute infections and is a reliable marker for acute disease. In some cases, Hepatitis B core IgM antibody may be the only specific marker for the diagnosis of acute infection with Hepatitis B virus.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatitis B Virus Surface Antigen, CLIA Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
37567
2 mL serum
Plastic screw cap vial
Refrigerated 5 days, -20oC 4 weeks
Gross hemolysis, Lipemic
Chemiluminescent Competitive Immunoassay
HBsAg, derived from the viral envelope, is the first antigen to appear following infection and can be detected serologically as an aid in the laboratory diagnosis of acute HBV infection.
Hepatitis Be Antibody 556
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Lipemia • Plasma
MethodologyChemiluminescence
Clinical Significance
The presence of anti-HBe serves to distinguish these two periods and confirms a seroconversion. The appearance of anti-HBe or the seroconversion from HBeAg positivity to anti-HBe positivity thus indicates a reduced level of infectious virus because virus replication has decreased. Though resolution of the disease generally follows, an HBsAg carrier state may persist. Anti-HBe positivity in this carrier is often associated with chronic asymptomatic infection. During the HBeAg positive stage, therefore, Hepatitis B patients are at increased risk of transmitting the virus to their contacts. Persistence of HBeAg in the Hepatitis B virus carrier is often associated with chronic active hepatitis.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatitis Be Antigen and Antibodies serum 78558
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Lipemia • Plasma
MethodologyChemiluminescence
Clinical Significance
Persistence of HBeAg for greater than 6 months is a prognostic indicator of a chronic hepatitis B virus carrier state. The presence of anti-HBe serves to distinguish these two periods and confirms a seroconversion. The appearance of anti-HBe or the seroconversion from HBeAg positivity to anti-HBe positivity thus indicates a reduced level of infectious virus because virus replication has decreased. Though resolution of the disease generally follows, an HBsAg
carrier state may persist. Anti-HBe positivity in this carrier is often associated with chronic asymptomatic infection. During the HBeAg positive stage, therefore, Hepatitis B patients are at increased risk of transmitting the virus to their contacts. Persistence of HBeAg in the epatitis B virus carrier is often associated with chronic active hepatitis.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
115
G
H
Hepatitis B Core IgM Antibody 4848
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
Hepatitis B core-specific IgM class antibody has been detected in most acute infections and is a reliable marker for acute disease. In some cases, hepatitis B core IgM antibody may be the only specific marker for the diagnosis of acute infection with hepatitis B virus.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation
Hepatitis B Surface Antibody, Qualitative G
H
499
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyChemiluminescence
Clinical Significance
The detection of anti-HBs is indicative of a prior immunologic exposure to the antigen or vaccine. To determine immune status as > 10 uIU/mL as per CDC guidelines, please order Hepatitis B Surface Antibody, Quantitative.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation
Hepatitis B Surface Antibody, Quantitative 8475
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Sodium citrate (light blue-top) tubes • Hyperlipemia
MethodologyChemiluminescence
Clinical Significance
This assay is used to determine immune status for Hepatitis B as > 10 uIU/mL as per CDC Guidelines. See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatitis B Viral DNA, Quantitative, PCR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Hepatitis Be Antigen 8369
2 mL plasma collected in a PPT-Potassium EDTA (white-top) tube.
EDTA plasma: Separate plasma within 6 hours of collection, transfer plasma to a sterile, screw-capped plastic aliquot tube. Freeze immediately at -20° C. Ship frozen.
Plastic screw-cap vial
Refrigerated 7 days, Frozen 35 days
Received room temperature • SST® (red-top/glass) • Unspun PPT tube
Real-Time Polymerase Chain Reaction (RT-PCR)
Chronic carriers will persist in producing detectable HBV. Patients with chronic liver disease of unknown origin most commonly have HBV that is detected by viral DNA testing. Quantitative measurement of HBV viral DNA may be used to monitor progression of disease.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
555
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Lipemia • Plasma
MethodologyChemiluminescene
Clinical Significance
Persistence of HBeAg for greater than 6 months is a prognostic indicator of a chronic hepatitis B virus carrier state.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
116
Hepatitis C Antibody 8472
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 7 days, -20oC 4 weeks
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
Hepatitis C Virus (HCV) is the major cause of hepatitis. Approximately 1% of blood donors are seropositive for anti-HCV. The clinical symptoms of a HCV infection are variable. Exposure to HCV results in a chronic infection in 50 to 80% of cases. The “window” between infection and seroreactivity is highly variable, up to 12 months.
See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatitis C Virus RNA, Quantitative, Real-Time PCR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
35645
3 mL frozen plasma collected in a PPT EDTA (whitetop) tube or EDTA (lavender-top) tube
Separate plasma from cells by centrifugation within 6 hours of sellection and transfer plasma to sepreate plastic screw cap vial.
Plastic screw-cap vial
Refrigerated 5 days, Frozen 35 days
Received refrigerated later than 72 hours from collection • Received room temperature • Received thawed
Real-Time Polymerase Chain Reaction (PCR)
Useful in monitoring therapy and disease progression.Reportable range is 50 to 50,000,000 IU/mL. See Hepatitis in the Infectious Disease section of Test Application and Interpretation.
Hepatitis E Antibody (IgG) 36583
Preferred Specimen(s)
1 mL serum collected in a (red-top) tube (no gel).
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days, -20oC Long term
MethodologyELISA
Clinical Significance
Hepatitis E virus (HEV) is the major etiologic agent of enterically transmiited non-A, non-B hepatitis worldwide and has a high case-fatality rate in pregnant women. Both IgM and IgG antibody to HEV (anti-HEV) are produced following infection. The titer of IgM anti-HEV
declines rapidly during early convalescence; IgG anti-HEV persists and appears to provide at least short-term protection against disease.
Hepatitis E Antibody (IgM) 36582
Preferred Specimen(s)
0.5 mL serum collected in a red-top tube (no gel).
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days, -20oC Long term
MethodologyELISA
Clinical Significance
Hepatitis E causes an acute, self-limiting infection. Antibody IgG is detected after Antibody IgM is detected, typically 1 month post-infection. Antibody IgM is detected 1-4 weeks post-
infection.
Hepatitis B Viral DNA, Qualitative, RT-PCR Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78018
2 mL plasma collected in an EDTA (lavender-top) tube
Separate plasma from cells by centrifugation within six hours of collection and transfer the plasma to a separate plastic screw-cap vial. Ship frozen.
Plastic screw-cap vial
Refrigerated 7 days, Frozen 35 days
Received room temperature • Received thawed • Serum • Heparinized plasma • Received frozen PPT (white-top) tubes • Unspun PPT tube
Real Time Polymerase Chain Reaction (RT-PCR)
This test is useful in the monitoring of therapy and disease progression
Hepatitis C Virus RNA, Qualitative PCR 34024
117
G
H
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
3 mL frozen plasma collected in a PPT (white-top EDTA) tube or EDTA (lavender-top) tube
Separate plasma from cells by centrifugation within six hours of selection and transfer the seprated plasma into screw cap vail
plastic screw-cap vial
Refrigerated 5 days, Frozen 35 days
Received refrigerated later than 72 hours from collection • Received room temperature
Real-Time Polymerase Chain Reaction
Useful in monitoring therapy and disease progression.
Herpes Simplex Virus 1 IgG, Type Specific Antibody G
H
79488
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature 8 hrs, Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing
is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients. See STI/Genitourinary Infections in Infectious Diseases section of Test Application and Interpretation.
Herpes Simplex Virus 2 IgG, Type Specific Antibody 79489
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature 8 hrs, Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyELISA
Clinical Significance
Herpes simplex virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients. See STI/Genitourinary Infections in Infectious Diseases section of Test Application and Interpretation.
Herpes Simplex Virus 1 & 2, IgG 6447
Preferred Specimen(s)
1 mL serum
Instructions
Specimen may be collected in an SST red top glass tube and transferred to plastic for transport. Do not submit glass tubes.
Transport Container
No additive (red-top) tube
Transport Temperature
Room Temperature 8 hrs, Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from self-limiting to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while 118
HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 1 & 2, IgG and IgM 10014
Preferred Specimen(s)
1 mL serum
Instructions
Specimen may be collected in an SST red top glass tube and transferred to plastic for transport. Do not submit glass tubes.
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from in apparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 1 & 2, IgM 17369
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 4 days, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 1, IgG and IgM 78547
Preferred Specimen(s)
1 mL serum
Instructions
Specimen may be collected in an SST red top glass tube and transferred to plastic for transport. Do not submit glass tubes.
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from in apparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections,
while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific 119
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typing is not usually required for diagnosis or treatment. The mean time to seroconversion sing the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 1, IgM G
H
79490
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 4 days, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from in apparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal
infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 2, IgG and IgM 78548
Preferred Specimen(s)
1 mL serum
Instructions
Specimen may be collected in an SST red top glass tube and transferred to plastic for transport. Do not submit glass tubes.
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 48 hrs, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from in apparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Herpes Simplex Virus 2, IgM 79491
Preferred Specimen(s)
1 mL serum
Instructions
Separate serum from cells as soon as possible
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 4 days, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes,meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two types of HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for 120
use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.
Highly Sensitive CRP
See “Cardio CRP™”
HIV Prognosticator Panel HIV Quantitative, CD3, CD4, and CD8 Absolute and Percentage counts 78540
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
2 mL whole blood plasma collected in an EDTA (lavender-top) tube in two tubes For follow up patients of CD4/CD8 counts collect sample at the same time of the day
Separate plasma from cells by centrifugation within two hours of collection and transfer the plasma to a separate plastic screw-cap vial. Ship frozen. For flow cytometry samples have to be sent at room temperature at 20- 25°C
Plastic screw-cap vial EDTA tube for flow samples
Frozen for Viral load Room temperature for flow
Received room temperature • Received thawed • Serum • Heparinized plasma • Received frozen PPT (white-top) tubes • Unspun PPT tube
Reverse Transcriptase Polymerase Chain Reaction (RTPCR) Flow cytometry
This test is useful in the monitoring of therapy and disease progression
HIV-1 and 2 Antibody 19923
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 5 days, -20oC 4 weeks
MethodologyChemiluminescene
Clinical Significance
The combination of HIV -1/HIV -2 includes detecion of subtype HIV -1. HIV -2 is closely releted to HIV - 1 regarding nucleic acid sequence and clinical disease.
HIV-1 Antibody Confirmation by Western Blot Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
This test should be ordered only as a confirmation for a previously positive HIV EIA screening test
1 mL serum
Tube must be labeled with patient identifier
Plastic screw-cap vial or original collection tube with the patient’s name or ID number
Refrigerated 3 days, -20oC Long term
Specimens that are not properly labeled with patient identifier • Gross hemolysis • Hyperlipemia
Western Blot
The etiological agent of acquired immunodeficiency syndrome (AIDS) has been recognized as a retrovirus, human immunodeficiency virus (HIV-1). The virus is believed to be transmitted by sexual contact, blood transfusion, feto-maternal transmission, breast feeding
and intravenous drug abuse. The presence of circulating antibodies to the virus indicates prior exposure of the individual to viral antigen(s). The presence of antibody to HIV is not in itself diagnostic of AIDS. Likewise, a non-reactive test result does not exclude the possibility of exposure to or infection with HIV. Specimens that screen positive and are repeatedly
reactive are confirmed by Western Blot. See the HIV section in the Infectious Disease section of Test Application and Interpretation.
HIV-1 RNA, Quantitative, PCR, Expanded Range Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
79003
14484
2 mL plasma collected in a (lavender-top) EDTA tube
Separate plasma from the cells by centrifugation within six hours of collection, and transfer the plasma to a separate plastic screw-cap vial. Ship frozen.
Plastic screw-cap vial
Refrigerated 5 days, Frozen 35 days
Received thawed • Serum • Heparinized plasma • Frozen PPT (white-top) tubes
121
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Methodology
Clinical Significance
Polymerase Chain Reaction (PCR)
Useful in the monitoring therapy and disease progression. The reportable range is 20 to 221*107 copies/mL. See HIV-1 RNA, Quantitative in the Infectious Disease section of Test Application and Interpretation.
HIV-1 RNA, Qualitative, RT-PCR 37815
Preferred Specimen(s)
2 mL plasma collected in an EDTA (lavender-top) tube or PPT (white-top) tubes.
Instructions
Separate plasma from cells by centrifugation within six hours of collection and transfer the plasma to a separate plastic screw-cap vial. Ship frozen. Do not freeze PPT tubes.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Received thawed • Serum • Heparinized plasma • Received frozen PPT (white-top) tubes • Unspun PPT tube
Methodology
Real time Polymerase Chain Reaction (RT-PCR)
Clinical Significance
Useful in the monitoring therapy and disease progreffion.
G
H
HLA B27 DNA Typing PCR Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
15584
3.0 mL Whole Blood in EDTA vial.
Collection Vial
Refrigerated 7 days, 20-26oC 7 days
Received Frozen
Polymerase Chain Reaction
HLA-B-27 positive individuals have a higher possibility of developing ankylosing spondylitis as opposed to HLAB27 negative individuals.
Homocysteine, Cardiovascular 31789
Patient Preparation
Fasting for at least 8 hours is preferred
Preferred Specimen(s)
1 mL serum or EDTA plasma
Instructions
EDTA plasma: Place the specimen in the refrigrator or ice bath until the specimen can be centrifuged. Centrifuge the specimen as soon as possible and seperate the plasma to plastic screw cap vial
Red-top tube: Place the specimen in the refrigerator or ice bath for 30 minutes after collection. Centrifuge the specimen as soon as possible after complete clot formation. Transfer the serum to a plastic specimen transport tube. Mark the specimen type as serum on the transport tube.
Barrier gel separator tube: Place the specimen in arefrigerator for 30 minutes after collection. Do not place barrier tubes in an ice bath as freezing may prevent the barrier gel from adequately separating from cells. Centrifuge specimen as soon as possible after complete clot formation, ensuring that the barrier gel completely separates serum from cells.
Note: It is very important to centrifuge and separate serum or plasma from red blood cells as soon as possible to avoid falsely elevated results.
Transport Container
Plastic screw-cap vial
Transport Temperature
Frozen 3 months, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Unseparated serum or plasma • Whole blood specimens
MethodologyChemiluminescence
Clinical Significance
Elevated levels of homocysteine are observed in patients at risk for coronary heart disease and stroke. See Non-Lipid Markers in the Cardiovascular Disease section and Biochemical 122
Markers in the Genetics section of Test Application and Interpretation.
Homocysteine, Nutritional and Congenital 36362
Patient Preparation
Fasting for at least 8 hours is preferred
Preferred Specimen(s)
1 mL serum or EDTA plasma
Instructions
EDTA plasma: Place the specimen in the refrigrator or ice bath until the specimen can be centrifuged. Centrifuge the specimen as soon as possible and seperate the plasma to plastic screw cap vial
Red-top tube: Place the specimen in the refrigerator or ice bath for 30 minutes after collection. Centrifuge the specimen as soon as possible after complete clot formation. Transfer the serum to a plastic specimen transport tube. Mark the specimen type as serum on the transport tube.
Barrier gel separator tube: Place the specimen in a refrigerator for 30 minutes after collection. Do not place barrier tubes in an ice bath as freezing may prevent the barrier gel from adequately separating serum from cells. Centrifuge specimen as soon as possible after complete clot formation, ensuring that the barrier gel completely separates serum from cells.
Note: It is very important to centrifuge and separate serum or plasma from red blood cells as soon as possible to avoid falsely elevated results
Transport Container
Plastic screw-cap vial
Transport Temperature
Frozen 3 months, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Unseparated serum or plasma • Whole blood specimens
MethodologyChemiluminescence
Clinical Significance
Diagnose and monitor treatment of homocystinuria, folate deficiency, or vitamin B12 deficiency. See Homocysteine in the Genetics section of Test Application and Interpretation.
HPV DNA, High Risk (cervista) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10ml servical specimen collected with appropriate collection device.
Collect the sample as usual according to manufacturer instruction.
Thin prep vial
Room Temperature 3 months, Refrigerated 3 months
Specimens other than ThinPrep. For example sample colleted in Qiagen Specimen Transport or SurePath cell pellet fraction specimens.
Third Wave Technologies Invader(R) signal amplification
HPV is the causative agent of cervical dysplasia and cervical carcinoma.
See Cervical Cancer in the Hematology/Oncology section of Interpretive Information
HPV Genotypes 16 & 18 (Cervista) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79557
79558
10 mL Cervical specimens collected with an appropriate collection device and placed in Cytyc PreservCyt Solution, (ThinPrep Vial).
Collect the sample as usual according to the manufacturers instructions.
ThinPrep Vial
Room Temperature 3 months, Refrigerated 3 months
Specimens other than ThinPrep. For example sample colleted in Qiagen Specimen Transport or SurePath cell pellet fraction specimens
Third Wave Technologies Invader(R) signal amplification
Persistent infection with any of the 14 high-risk HPV types increases a woman’s risk for progression to dysplasia or cervical cancer. The rate of progression or degree of risk depends on the HPV type. Of all 14 highrisk types, HPV Types 16 and 18 cause more than 60-65% od cervical cancers. This test will identify the presence or absence of HPV Type 16 DNA and /or Type 18 DNA in PreservCyt ThinPrep. Knowledge of the HPV genotype will help physicians diagnose the type of HPV infection and its risk of delevoping into dysplasia or cervical cancer.
hs-CRP
See “Cardio CRP™”
123
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IBD Panel
See “Inflammatory Bowel Disease Differential Panel”
IF-Blocking Antibody
See “Intrinsic Factor Blocking Antibody”
IFE, Serum
See “Immunofixation (IFE), Serum”
IGF BINDING PROTEIN-1 36590
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport TemperatureRefrigerated
Reject Criteria
Gross hemolysis • Hyperlipemia • Serum received room temperature
MethodologyRadioimmunoassay
Clinical Significance
IGF-I (somatomedin-C) measurements are useful in the evaluation of growth deficiencies and acromegaly
I
J
IHC-AE1/AE3 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Lines the normal and neoplastic epithelium of simple and complex epithelia. It is crucial in diagnostic IHC for identification of carcinomatous differentiation.
IHC-AE1/AE3 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
124
78701
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Lines the normal and neoplastic epithelium of simple and complex epithelia. It is crucial in diagnostic IHC for identification of carcinomatous differentiation.
IHC-AFP With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78700
78821
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Major plasma protein of early fetus; synthesized by the cells of the embryonic yolk sac, fetal gut and liver. AFP expression demonstrated in many hepatocellular carcinomas, and in extragonadal and gonadal germ cell tumors, including yolk sac tumors.
IHC-AFP Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Major plasma protein of early fetus; synthesized by the cells of the embryonic yolk sac, fetal gut and liver. AFP expression demonstrated in many hepatocellular carcinomas, and in extragonadal and gonadal germ cell tumors, including yolk sac tumors.
IHC-ANNEXIN A1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78774
10 % neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A member of the annexin family of calcium binding proteins, and has roles in many diverse cellular functions, such as membrane aggregation, inflammation, phagocytosis, proliferation, apoptosis, and tumorigenesis and cancer development.Strongly expressed in 97% of patients with hairy cell leukemia and can be used to differentiate this disease from other B-cell
lymphomas; esophageal and esophagogastric junction adenocarcinomas
IHC-BCL2 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78773
10 % neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10 % neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A member of the annexin family of calcium binding proteins, and has roles in many diverse cellular functions, such as membrane aggregation, inflammation, phagocytosis, proliferation, apoptosis, and tumorigenesis and cancer development.Strongly expressed in 97% of patients with hairy cell leukemia and can be used to differentiate this disease from other B-cell lymphomas; esophageal and esophagogastric junction adenocarcinomas
IHC-ANNEXIN A1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78812
78759
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Bcl2 is a proto-oncogene ; maintains memory B cells, plasma cells and neurons by prolonging life span without cell division. Used to distinguish follicular hyperplasia of lymph node (germinal centers are bcl2 negative) and follicular lymphoma (germinal centers are bcl2 positive), but also positive in other lymphomas.
125
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IHC-BCL2 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Bcl2 is a proto-oncogene ; maintains memory B cells, plasma cells and neurons by prolonging life span without cell division. Used to distinguish follicular hyperplasia of lymph node (germinal centers are bcl2 negative) and follicular lymphoma (germinal centers are bcl2 positive), but also positive in other lymphomas.
IHC-BCL6 With Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
126
78789
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Antibody to cell membrane glycoproteins; does not react with cytokeratin.100% sensitive, 91% specific marker for lung adenocarcinoma vs. mesothelioma differentiation; also useful in diagnosing mammary Paget’s disease.
IHC-BER-EP4 without Interpretation Preferred Specimen(s)
78762
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Transcription factor involved in cell proliferation and differentiation; selectively expressed by germinal center cells. Positive staining (disease): 30-80% of large cell lymphomas, 6-10% of follicular lymphomas.
IHC-BER-EP4 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78761
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Transcription factor involved in cell proliferation and differentiation; selectively expressed by germinal center cells. Positive staining (disease): 30-80% of large cell lymphomas, 6-10% of follicular lymphomas.
IHC-BCL6 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78760
78790
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Antibody to cell membrane glycoproteins; does not react with cytokeratin.100% sensitive, 91% specific marker for lung adenocarcinoma vs. mesothelioma differentiation; also useful in diagnosing mammary Paget’s disease.
IHC-BRCA1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A tumor suppressor gene which confers susceptibility to breast and ovarian cancer. BRCA1 or BRCA2 mutation is associated with medullary carcinoma of breast (more favorable prognosis),adenocarcinomas of colon, ovary and prostate.BRCA1 or BRCA2 mutation is
associated with medullary carcinoma of breast (more favorable prognosis),adenocarcinomas of colon, ovary and prostate.
IHC-BRCA1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78842
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A tumor suppressor gene which confers susceptibility to breast and ovarian cancer. BRCA1 or BRCA2 mutation is associated with medullary carcinoma of breast (more favorable prognosis), adenocarcinomas of colon, ovary and prostate.BRCA1 or BRCA2 mutation is
associated with medullary carcinoma of breast (more favorable prognosis),adenocarcinomas of colon, ovary and prostate.
IHC-BRCA2 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78841
78798
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A tumor suppressor gene and is a sensitive marker for breast and ovarian cancers in women. BRCA1 or BRCA2 mutation is associated with medullary carcinoma of breast (more favorable
rognosis), adenocarcinomas of colon, ovary and prostate; men with BRCA2 mutation also have higher risk of breast cancer.
IHC-BRCA2 without Interpretation 78799
127
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Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10%
neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A tumor suppressor gene and is a sensitive marker for breast and ovarian cancers in women. BRCA1 or BRCA2 mutation is associated with medullary carcinoma of breast (more favorable
prognosis), adenocarcinomas of colon, ovary and prostate; men with BRCA2 mutation also have higher risk of breast cancer.
IHC-34 Beta E12 With Interpretation I
J
78736
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
The antibody labels squamous, ductal and complex epithelia and virtually all of the normal basal cells of prostate.Helps to establish a benign or malignant diagnosis of prostatic adenocarcinoma.
IHC-34 Beta E12 Without Interpretation 78737
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
The antibody labels squamous, ductal and complex epithelia and virtually all of the normal basal cells of prostate.Helps to establish a benign or malignant diagnosis of prostatic adenocarcinoma.
IHC-CA19.9 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested. Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Majority of tumors of gastrointestinal tract and pancreas express CA19.9
IHC-CA19.9 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
128
78830
78831
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested. Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Methodology
Clinical Significance
Immunohistochemical Assay (IHC)
Majority of tumors of gastrointestinal tract and pancreas express CA19.9
IHC-CA125 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Recognizes a mucin like glycoprotein, expressesing the CA 125 epitope.This antibody labels a variety of tumors such as some adenocarcinomas of the colon, breast carcinomas, uterine adenomatoid tumor, bronchoalveolar carcinoma and ovarian endometroid and serous carcinomas. Antibodies to CA 125 may be useful for the differential diagnosis of adenocarcinomas, as positive reactivity in prostate, colorectal and renal carcinomas is rare.
IHC-CA125 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78708
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
convoluted tubules, eccrine glands and thymic keratinized cells. Typically used as a marker for neural, mesothelial, ovarian sex- cord stromal and adrenal cortical tumors; suggested in differentiation of epithelial malignant mesotheliomas from lung adenocarcinomas.
IHC-Calretinin Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
78875
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Recognizes a mucin like glycoprotein, expressesing the CA 125 epitope.This antibody labels a variety of tumors such as some adenocarcinomas of the colon, breast carcinomas, uterine adenomatoid tumor, bronchoalveolar carcinoma and ovarian endometroid and serous carcinomas. Antibodies to CA 125 may be useful for the differential diagnosis of adenocarcinomas, as positive reactivity in prostate, colorectal and renal carcinomas is rare.
IHC-Calretinin With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78874
78709
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
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Clinical Significance
Expressed in central and peripheral neural tissues particularly in retina and neurons of sensory pathways, normal and neoplastic mesothelial cells, steroid producing cells, renal convoluted tubules, eccrine glands and thymic keratinized cells. Typically used as a marker for neural, mesothelial, ovarian sex- cord stromal and adrenal cortical tumors; suggested in differentiation of epithelial malignant mesotheliomas from lung adenocarcinomas.
IHC-CD2 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A transmembrane glycoprotein that is considered a pan T cell antigen expressed on a majority of thymocytes and virtually all peripheral T lymphocytes. Useful for identification of peripheral T- cell lymphoma, anaplastic large cell lymphoma and precursor T-cell lymphoma.
IHC-CD2 without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
130
78702
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Binds with T cell antigen receptor in the cell membrane and is specific for T cells. Expressed by peripheral T cells, thymocytes and activated natural killer cells and is present in great majotity of T cell lymphomas
IHC-CD3 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
78846
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A transmembrane glycoprotein that is considered a pan T cell antigen expressed on a majority of thymocytes and virtually all peripheral T lymphocytes. Useful for identification of peripheral T- cell lymphoma, anaplastic large cell lymphoma and precursor T-cell lymphoma.
IHC-CD3 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78845
78703
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines.
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Clinical Significance
Binds with T cell antigen receptor in the cell membrane and is specific for T cells. Expressed by peripheral T cells, thymocytes and activated natural killer cells and is present in great majotity of T cell lymphomas
IHC-CD4 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Nonpolymorphous transmembrane glycoproteins belonging to immunoglobulin superfamily expressed on majority of mature peripheral T cells. Useful for identification of anaplastic large cell lymphoma and unspecified peripheral T- cell lymphoma.
IHC-CD4 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78749
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
CD5+ B cells, which may arise from B-1 cells (subset of B cells) produce generalist antibodies; the first line of defense against antigens.Used as a marker for CLL, mantle cell lymphoma, T cells (normal and malignant) and thymic carcinoma.
IHC-CD7 with Interpretation Preferred Specimen(s)
78748
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
CD5+ B cells, which may arise from B-1 cells (subset of B cells) produce generalist antibodies; the first line of defense against antigens.Used as a marker for CLL, mantle cell lymphoma, T cells (normal and malignant) and thymic carcinoma.
IHC-CD 5 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78840
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Nonpolymorphous transmembrane glycoproteins belonging to immunoglobulin superfamily expressed on majority of mature peripheral T cells. Useful for identification of anaplastic large cell lymphoma and unspecified peripheral T- cell lymphoma.
IHC-CD 5 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78839
78765
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 131
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Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Expressed by the majority of peripheral blood T cells, NK cells, and all thymocytes. It is one of the earliest surface antigens on T and NK-cell lineages, and the antibody is useful for the classification of T-cell malignancies.
IHC-CD7 without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Expressed by the majority of peripheral blood T cells, NK cells, and all thymocytes. It is one of the earliest surface antigens on T and NK-cell lineages, and the antibody is useful for the classification of T-cell malignancies.
IHC-CD8 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
132
78814
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A transmembrane glycoprotein expressed by majority of thymocytes, and by class I major histocompatibility complex restricted, mature, suppressor/cytotoxic T cells. Useful for identification of cytotoxic/suppressor T cells and their neoplastic counteparts.
IHC-CD10 with interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
78813
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A transmembrane glycoprotein expressed by majority of thymocytes, and by class I major histocompatibility complex restricted, mature, suppressor/cytotoxic T cells. Useful for identification of cytotoxic/suppressor T cells and their neoplastic counteparts.
IHC-CD8 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78766
78742
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Clinical Significance
Immunohistochemical Assay (IHC)
Characteristic marker of follicular center cells and follicular lymphoma.Marker for germinal center phenotype and used to identify Acute lymphoblastic leukemia (ALL), Angioimmunoblastic T cell lymphoma and Burkitt’s lymphoma.
IHC-CD10 without interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78743
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Characteristic marker of follicular center cells and follicular lymphoma.Marker for germinal center phenotype and used to identify Acute lymphoblastic leukemia (ALL), Angioimmunoblastic T cell lymphoma and Burkitt’s lymphoma.
IHC-CD15 With Interpretation 78847
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
A carbohydrate adhesion molecule (not a protein) that mediates phagocytosis and chemotaxis.
Used as a confirmatory marker for diagnosis of Hodgkin’s lymphoma, helps differentiate between Hodgkin’s lymphoma and anaplastic large cell lymphoma, adenocarcinoma and mesothelioma.
IHC-CD15 without Interpretation 78848
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
A carbohydrate adhesion molecule (not a protein) that mediates phagocytosis and chemotaxis.
Used as a confirmatory marker for diagnosis of Hodgkin’s lymphoma, helps differentiate between Hodgkin’s lymphoma and anaplastic large cell lymphoma, adenocarcinoma and mesothelioma.
IHC-CD20 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
78726
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
133
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Clinical Significance
Acquired late in the pre-B-cell stage of maturation, and remains on cells throughout most of their differentiation. Positive in B cell Lymphoblastic Leukemia/Lymphoma and all mature B cell Lymphomas (except plasma cell lesions) and Reed-Sternberg cells in 25% cases of classical Hodgkin’s disease
IHC-CD20 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Acquired late in the pre-B-cell stage of maturation, and remains on cells throughout most of their differentiation. Positive in B cell Lymphoblastic Leukemia/Lymphoma and all mature B cell Lymphomas (except plasma cell lesions) and Reed-Sternberg cells in 25% cases of classical Hodgkin’s disease
IHC-CD21 with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
134
78768
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
CD21 is expressed by follicular dendritic cells, mature B cells as well as several types of epithelial cells. Used to diagnose follicular dendritic cell sarcomas, distinguishes cutaneous or nodal mantle cell lymphoma from follicular lymphoma.
IHC-CD23 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78767
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
CD21 is expressed by follicular dendritic cells, mature B cells as well as several types of epithelial cells. Used to diagnose follicular dendritic cell sarcomas, distinguishes cutaneous or nodal mantle cell lymphoma from follicular lymphoma.
IHC-CD21 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78729
78817
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A dendritic cell marker and acts as a B cell growth and activation factor.Strongly expressed on B cells and monocytes, including a strong expression on Epstein Barr virus transformed B lymphoblasts. A B cell marker particularly for SLL/CLL, mediastinal large B cell lymphoma and lymphoplasmacytic lymphoma and may be used to differentiate B-CLL (B - cell chronic lymphocytic Leukemia /Lymphoma) from mantle cell lymphoma or MALT lymphoma.
IHC-CD23 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry &Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A dendritic cell marker and acts as a B cell growth and activation factor.Strongly expressed on B cells and monocytes, including a strong expression on Epstein Barr virus transformed B lymphoblasts. A B cell marker particularly for SLL/CLL, mediastinal large B cell lymphoma and lymphoplasmacytic lymphoma and may be used to differentiate B-CLL (B - cell chronic lymphocytic Leukemia /Lymphoma) from mantle cell lymphoma or MALT lymphoma.
IHC-CD 30 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78780
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Member of tumor necrosis factor family of cell surface receptors; also a lymphocyte activation antigen.Confirms diagnosis of Anaplastic large cell lymphoma, Classic Hodgkin’s lymphoma, Embryonal carcinoma; other lymphoma diagnosis.
IHC-CD31 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78758
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Member of tumor necrosis factor family of cell surface receptors; also a lymphocyte activation
antigen.Confirms diagnosis of Anaplastic large cell lymphoma, Classic Hodgkin’s lymphoma, Embryonal carcinoma; other lymphoma diagnosis.
IHC-CD 30 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78818
78793
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker strongly labels endothelial cells and confirms vascular origin of tumors and 135
I
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highlights vessels arising from endothelial cells. CD31 is the most sensitive and specific endothelial marker in paraffin sections; stains small and large vessels.
IHC-CD31 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker strongly labels endothelial cells and confirms vascular origin of tumors and highlights vessels arising from endothelial cells. CD31 is the most sensitive and specific endothelial marker in paraffin sections; stains small and large vessels.
IHC-CD34 with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
136
78785
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
An integeral membrane protein typically expressed at high levels on all leukocytes, except most resting B lymphocytes.Also useful in diagnosing AML, granulocytic sarcoma, hemangioma, Langerhans cell histiocytosis, mast cell disease, plasmacytoma and early
colonic adenoma.
IHC-CD43 without Interpretation Preferred Specimen(s)
78770
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Intercellular adhesion protein and cell surface glycoprotein; expressed in immature haemotopoeitic stem cells, capillary endothelial cells, embryonic fibroblasts and rare glial cells in nervous tissue. Useful marker for diagnosis of pre B ALL, alveolar soft part sarcoma,
AML, angiosarcoma.
IHC-CD43 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78769
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Intercellular adhesion protein and cell surface glycoprotein; expressed in immature haemotopoeitic stem cells, capillary endothelial cells, embryonic fibroblasts and rare glial cells in nervous tissue. Useful marker for diagnosis of pre B ALL , alveolar soft part sarcoma,
AML, angiosarcoma.
IHC-CD34 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78794
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
78786
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
An integeral membrane protein typically expressed at high levels on all leukocytes , except most resting B lymphocytes.Also useful in diagnosing AML, granulocytic sarcoma, hemangioma, Langerhans cell histiocytosis, mast cell disease, plasmacytoma and early
colonic adenoma.
IHC-CD 45 With Interpretation 78746
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
CD 45 is membrane tyrosine protein phosphatase found on all leukocytes.An essential regulator of T and B cell antigen receptor-mediated activation; also required for thymic selection.
IHC-CD 45 Without Interpretation 78747
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
CD 45 is membrane tyrosine protein phosphatase found on all leukocytes.An essential regulator of T and B cell antigen receptor-mediated activation; also required for thymic selection.
IHC-CD56 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Also called N-CAM (neural cell adhesion molecule), it contributes to cell-cell or cell-matrix adhesion during development.Used as a marker for NK cells and NK lymphomas, neuroblastomas and small lung cell carcinomas. Useful for labelling atypical plasma cells.
IHC-CD56 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
78783
78784
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
137
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Reject Criteria
Methodology
Clinical Significance
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Also called N-CAM (neural cell adhesion molecule), it contributes to cell-cell or cell-matrix adhesion during development.Used as a marker for NK cells and NK lymphomas, neuroblastomas and small lung cell carcinomas.
IHC-CD61 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Detects platelets in smears of blood and bone marrow and megakaryocytes in cell smears.
Valuable in diagnosis of megakaryoblastic leukemia and can also reveal absence of GpIIb/
IIIa in Glanzmann thrombasthenia.
IHC-CD61 without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
138
78797
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Lines human monocytes, macrophages and myeloid cells.Useful marker of histiocytes and histiocytic tumors and also useful in diagnosis of AML-M4/M5, angiosarcoma, atypical fibroxanthoma, B cell lymphoma (some), blastic NK lymphoma, calcifying aponeurotic
fibroma, and cellular fibrous histiocytoma.
IHC-CD 68 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
78858
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Detects platelets in smears of blood and bone marrow and megakaryocytes in cell smears. Valuable in diagnosis of megakaryoblastic leukemia and can also reveal absence of GpIIb/IIIa in Glanzmann thrombasthenia.
IHC-CD68 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78857
78832
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Clinical Significance
Lines human monocytes, macrophages and myeloid cells.Useful marker of histiocytes and histiocytic tumors and also useful in diagnosis of AML-M4/M5, angiosarcoma, atypical fibroxanthoma, B cell lymphoma (some), blastic NK lymphoma, calcifying aponeurotic
fibroma, and cellular fibrous histiocytoma.
IHC-CD79a with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
CD79a markers are expressed on specific B-cell type lymphoid cells. Individual and a series of IHC markers can be run on unknown cells and presence or absence of the antigen can help to characterize the cell of interest.
IHC-CD79a without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78836
78833
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Expressed early in B-cell differentiation ; also expressed in plasma cells.Useful marker for general detection of B cells; also used in ALL or small B cell lymphoproliferative disorders when CD20 may be negative or after rituximab (anti CD-20) therapy , in infarcted lymphomas and to differentiate pre B lymphoblastic lymphoma from Ewing’s sarcoma.
IHC-CD99 with Interpretation 78781
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
Expressed on cell membrane of some lymphocytes, cortical thymocytes, granulosa cells of ovary, CNS ependymal cells and and Sertoli’s cells of testis.Relatively non-specific marker for Ewing’s sarcoma and T cell lymphoma, but does distinguish Ewing’s sarcoma from neuroblastoma; also distinguishes meningeal hemangiopericytoma from anaplastic meningiomas.
IHC-CD99 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78782
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Expressed on cell membrane of some lymphocytes, cortical thymocytes, granulosa cells of 139
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ovary, CNS ependymal cells and and Sertoli’s cells of testis.Relatively non-specific marker for Ewing’s sarcoma and T cell lymphoma, but does distinguish Ewing’s sarcoma from neuroblastoma; also distinguishes meningeal hemangiopericytoma from anaplastic meningiomas.
IHC-CDX 2 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Widely expressed in intestinal epithelium from the duodenum to the rectum. Positive in colorectal adenocarcinomas, primary and metastatic gastric adenocarcinomas and carcinoids as well as adenocarcinomas of the ovary, urinary bladder and pancreas.
IHC-CDX 2 without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78751
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Useful for identification of malignancies involving terminally differentiated plasma cells, and is associated with multiple myeloma. It might also be useful for the subclassification of difuse large B-cell lymphomas.
IHC-Chromogranin A with Interpretation 140
78750
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Useful for identification of malignancies involving terminally differentiated plasma cells, and is associated with multiple myeloma. It might also be useful for the subclassification of difuse large B-cell lymphomas.
IHC-CD138 without interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78728
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Widely expressed in intestinal epithelium from the duodenum to the rectum. Positive in colorectal adenocarcinomas, primary and metastatic gastric adenocarcinomas and carcinoids as well as adenocarcinomas of the ovary, urinary bladder and pancreas.
IHC-CD 138 With Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78727
78730
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A momomeric protein that composes the major portion of the neurosecretory granules of neuroendocrine cells (normal as well as neoplastic). Positive in tumors of neuroendocrine origin (Pheochromocytoma, carotid body tumor, medullary thyroid carcinoma, carcinoid).
IHC-Chromogranin A without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A momomeric protein that composes the major portion of the neurosecretory granules of neuroendocrine cells (normal as well as neoplastic). Positive in tumors of neuroendocrine origin (Pheochromocytoma, carotid body tumor, medullary thyroid carcinoma, carcinoid).
IHC-CK5/6 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78803
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
It labels mesothelioma and epithelial based cells in prostate and tonsil.Expressed at low levels in adenocarcinoma whereas present at high levels in epithelioid mesotheliomas and therefore used in differentiation between these types of cancers.
IHC-CK7 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
78802
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
It labels mesothelioma and epithelial based cells in prostate and tonsil.Expressed at low levels in adenocarcinoma whereas present at high levels in epithelioid mesotheliomas and therefore used in differentiation between these types of cancers.
IHC-CK5/6 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78731
78706
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
141
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Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
Lines the normal and neoplastic epithelia including many ductal and glandular epithelia. Diagnostic utility in carcinomas of ovary, salivary gland, lung, breast, endometrium and bladder
IHC-CK7 without Interpretation 78707
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
Lines the normal and neoplastic epithelia including many ductal and glandular epithelia. Diagnostic utility in carcinomas of ovary, salivary gland, lung, breast, endometrium and bladder
IHC-CK8 with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78808
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A low molecular weight keratin ; a component of nuclear inclusions of rhabdoid tumors and Mallory bodies; labels almost all non squamous epithelia. Useful marker to confirm epithelial nature of tissue/tumors, assess sentinel lymph nodes in colon carcinoma, and diagnose adenocarcinomas of ovary, gastrointestinal tract and thyroid and majority of ductal carcinoma.
IHC-CK8 without Interpretation 78809
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
A low molecular weight keratin ; a component of nuclear inclusions of rhabdoid tumors and Mallory bodies; labels almost all non squamous epithelia. Useful marker to confirm epithelial nature of tissue/tumors, assess sentinel lymph nodes in colon carcinoma, and diagnose adenocarcinomas of ovary, gastrointestinal tract and thyroid and majority of ductal carcinoma.
IHC-CK18(LMW) with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The antibody labels tumor cells of epithelial origin including many ductal and glandular epithelia. A useful tumor marker for breast cancer and bladder carcinoma.
IHC-CK18(LMW) without Interpretation 142
78868
78869
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The antibody labels tumor cells of epithelial origin including many ductal and glandular epithelia. A useful tumor marker for breast cancer and bladder carcinoma.
IHC-CK20 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Lines gastrointestinal epithelium and is useful in identification of GIT adenocarcinomas (colorectal, pancreatic, gall bladder). Also lines mucinous ovarian tumors, transitional cell and Merkel-cell carcinomas hence used in their diagnosis
IHC-CK20 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78815
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A proto-oncogene; acts as a receptor for kit protein, important for development and survival of mast cells, hematopoietic stem cells, melanocytes, germ cells, interstitial cells of Cajal. Useful marker for confirming diagnosis of GIST (gastrointestinal stromal tumors), AML, angiomyolipoma , angiosarcomas (50%), clear cell sarcoma, CML, epithelioid sarcoma, Ewing sarcoma, granulocytic sarcoma, Hodgkin’s lymphoma (some Reed-Sternberg cells).
IHC-CKIT (CD117) without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
78705
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Lines gastrointestinal epithelium and is useful in identification of GIT adenocarcinomas (colorectal, pancreatic, gall bladder). Also lines mucinous ovarian tumors, transitional cell and Merkel-cell carcinomas hence used in their diagnosis
IHC-CKIT (CD117) with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78704
78816
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
143
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Methodology
Clinical Significance
Immunohistochemical Assay (IHC)
A proto-oncogene; acts as a receptor for kit protein, important for development and survival of mast cells, hematopoietic stem cells, melanocytes, germ cells, interstitial cells of Cajal. Useful marker for confirming diagnosis of GIST (gastrointestinal stromal tumors), AML, angiomyolipoma , angiosarcomas (50%), clear cell sarcoma, CML, epithelioid sarcoma, Ewing sarcoma, granulocytic sarcoma, Hodgkin’s lymphoma (some Reed-Sternberg cells).
IHC-Collagen IV with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
I
J
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
The antibody is directed against collagen IV, a major constituent of the basement membrane. The antibody is important in demonstrating the loss of basement membrane components by invasive carcinomas.
IHC-Collagen IV without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
144
78837
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Cyclin D1 gene is amplified in a number of cancers and is therefore of interst in tumorigenesis investigations.Overexpression promotes transformation to a malignant phenotype; overexpressed in many tumors particularly Mantle cell lymphomas and also parathyroid adenomas, multiple myeloma and hairy cell leukemia.
IHC- Cyclin D1 Without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78882
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
The antibody is directed against collagen IV, a major constituent of the basement membrane. The antibody is important in demonstrating the loss of basement membrane components by invasive carcinomas.
IHC-Cyclin D1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78881
78838
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Cyclin D1 gene is amplified in a number of cancers and is therefore of interst in tumorigenesis
investigations. Overexpression promotes transformation to a malignant phenotype; overexpressed in many tumors particularly Mantle cell lymphomas and also parathyroid adenomas, multiple myeloma and hairy cell leukemia.
IHC-Cytoplasmic IgA with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Cytoplasmic IgA (Immunoglobulin A) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-Cytoplasmic IgA without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78825
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Cytoplasmic IgG (Immunoglobulin G) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-Cytoplasmic IgM with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
78824
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Cytoplasmic IgG (Immunoglobulin G) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-Cytoplasmic IgG without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78854
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Cytoplasmic IgA (Immunoglobulin A) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-Cytoplasmic IgG with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78853
78879
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
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Clinical Significance
Cytoplasmic IgM (Immunoglobulin M) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-Cytoplasmic IgM without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Cytoplasmic IgM (Immunoglobulin M) is expressed on specific hematologic cells. Useful in identifying leukemias, plasmacytomas, and B-cell lineage-derived lymphomas.
IHC-DBA44 with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
146
78884
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Antibody raised against B cell centroblastic cell line; sensitive and relatively specific marker for hairy cell leukemia. Stains positive in Hairy cell leukemia (particularly “hairy” cytoplasmic processes), splenic margin zone lymphoma (71%), follicular center cell lymphomas (46%) and high grade B cell lymphomas.
IHC-Desmin with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78883
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Antibody raised against B cell centroblastic cell line; sensitive and relatively specific marker for hairy cell leukemia. Stains positive in Hairy cell leukemia (particularly “hairy” cytoplasmic processes), splenic margin zone lymphoma (71%), follicular center cell lymphomas (46%) and high grade B cell lymphomas.
IHC-DBA44 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78880
78740
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Characteristically found in smooth and striated muscle cells and in neoplasms associated with them. A specific marker for myogenic differentiation among soft tissue tumors and is seen in rhabdomyomas, leiomyomas, rhabdomyosarcomas ,desmoid tumors and myofibromas.
IHC-Desmin without Interpretation 78741
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
Characteristically found in smooth and striated muscle cells and in neoplasms associated with them. A specific marker for myogenic differentiation among soft tissue tumors and is seen in rhabdomyomas, leiomyomas, rhabdomyosarcomas ,desmoid tumors and myofibromas.
IHC-EBV with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Labels the Epstein-Barr virus-encoded latent gene product, latent membrane protein (LMP). The antibody can be used for the demonstration of latent EBV infection in cells and tissues. EBV is associated with Hodgkin’s disease, nasopharyngeal carcinoma and nonlymphoblastic
T-cell lymphoma
IHC-EBV without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78835
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Labels the Epstein-Barr virus-encoded latent gene product, latent membrane protein (LMP). The antibody can be used for the demonstration of latent EBV infection in cells and tissues. EBV is associated with Hodgkin’s disease, nasopharyngeal carcinoma and nonlymphoblastic
T-cell lymphoma
IHC-E Cadherin with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78834
78826
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Calcium-dependent transmembrane epithelial protein that promotes intercellular adhesion; its loss is associated with invasive carcinoma.The antibody is useful for the identification of E-cadherin-positive cells in normal and neoplastic tissues. Strong marker for majority of
ductal breast carcinomas whereas the majority of lobular carcinoma of the breast showed weak or no labelling.
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IHC-E Cadherin without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Calcium-dependent transmembrane epithelial protein that promotes intercellular adhesion; its loss is associated with invasive carcinoma.The antibody is useful for the identification of E-cadherin-positive cells in normal and neoplastic tissues. Strong marker for majority of
ductal breast carcinomas whereas the majority of lobular carcinoma of the breast showed weak or no labelling.
IHC-EGFR with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78763
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A large cell surface mucin glycoprotein expressed by most glandular and ductal epithelial cells and some hematopoietic cells.Highly expressed by most adenocarcinomas and associated with poor prognosis; expressed by nearly all cases of Paget’s disease, and
associated with invasion in pancreatic tumors
IHC-EMA without Interpretation 148
78720
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
An important biomarker for several different tumor types as there are several FDA approved compounds that use this receptor for targeted drug therapy ; main tumor types being lung cancer, head and neck cancer and metastatic colon cancer. Overexpressed by many epithelial tumors including bladder cancers and also in a more virulent form of breast carcinoma.
IHC-EMA with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78719
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
An important biomarker for several different tumor types as there are several FDA approved compounds that use this receptor for targeted drug therapy ; main tumor types being lung cancer, head and neck cancer and metastatic colon cancer. Overexpressed by many epithelial tumors including bladder cancers and also in a more virulent form of breast carcinoma.
IHC-EGFR without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78827
78764
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A large cell surface mucin glycoprotein expressed by most glandular and ductal epithelial cells and some hematopoietic cells.Highly expressed by most adenocarcinomas and associated with poor prognosis; expressed by nearly all cases of Paget’s disease, and
associated with invasion in pancreatic tumors
IHC-ER/PgR/DNA, Paraffin Block Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
39479
Formalin-fixed, paraffin embedded tissue block or ten 4-micron unstained sections and six 50-micron shavings See Paraffin Blocks in the Tissue Pathology section of Specimen Collection and Handling.
Tumor paraffin block (formalin-fixed only). Please submit stained H & E slide and a copy of the pathology report. Do not place paper labels with adhesive backing on slides. Use pencil or xylene resistant pen to write on the frosted end of the slide only. Mention time to fixation and duration of fixation of breast biopsy or specimen.
Paraffin block bag
Room temperature
Received refrigerated • Received frozen
Immunohistochemical Assay (IHC)
Estrogen and progesterone receptor assays are routinely performed on breast carcinomas to assess responsiveness to endocrine therapy and prognosis.
IHC-ER/PgR with Interpretation 10736
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 5 in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For ER/PgR: Time to fixation should be less than one hour and duration of fixation should be more than 6 hrs and less than 72 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-ER/PgR without Interpretation
79495
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 5 in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For ER/PgR: Time to fixation should be less than one hour and duration of fixation should be more than 6 hrs and less than 72 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
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Reject Criteria
Methodology
Clinical Significance
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Immunohistochemical Assay (IHC)
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-ER/PgR/HER-2/neu with Interpretation
I
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78927
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 8 slides in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For ER/PgR: Time to fixation should be less than one hour and duration of fixation should be more than 6 hrs and less than 72 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 8 slides in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For HER-2/neu: Time to fixation should be less than one hour (shorter the better). Duration of fixation should be more than 6 hrs and less than 48 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-ER/PgR/HER-2/neu without Interpretation
79496
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 8 slides in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For ER/PgR: Time to fixation should be less than one hour and duration of fixation should be more than 6 hrs and less than 72 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
150
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 8 slides in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For HER-2/neu: Time to fixation should be less than one hour (shorter the better). Duration of fixation should be more than 6 hrs and less than 48 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-GFAP with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Intracytoplasmic filamentous protein that constitutes a portion of cytoskeleton in astrocytes (normal, reactive, neoplastic); a useful marker for CNS tumors and colonic schwannoma. With increasing astrocyte malignancy, there is progressive loss of GFAP production; used for identification of astrocytes in CNS in normal and pathological conditions.
IHC-GFAP without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78877
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Intracytoplasmic filamentous protein that constitutes a portion of cytoskeleton in astrocytes (normal, reactive, neoplastic); a useful marker for CNS tumors and colonic schwannoma. With increasing astrocyte malignancy, there is progressive loss of GFAP production; used for identification of astrocytes in CNS in normal and pathological conditions.
IHC-HEP PAR-1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78876
78778
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Hepatocyte Paraffin 1 marker determines hepatocellular origin, particularly in panel with 151
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alpha-fetoprotein and CEA or CD10.Useful marker for most hepatocellular carcinomas, and some non hepatocellular carcinomas metastatic to liver.
IHC-HEP PAR-1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Hepatocyte Paraffin 1 marker determines hepatocellular origin, particularly in panel with alpha-fetoprotein and CEA or CD10. Useful marker for most hepatocellular carcinomas, and some non hepatocellular carcinomas metastatic to liver.
IHC-Her2 neu I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78811
79021
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines. Mention time to fixation and duration of fixation of breast biopsy or specimen.
Paraffin block bag
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunocytochemical Assay
See Breast Cancer in the Hematology/Oncology section of Test Application and Interpretation.
IHC-HER-2/neu with Interpretation
79021
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 3 in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For HER2/neu: Time to fixation should be less than one hour (shorter the better). Duration of fixation should be more than 6 hrs and less than 48 hrs for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-HER-2/neu without Interpretation
79497
Preferred Specimen(s)
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides (minimum 3 in number) Tissue biopsy fixed in 10% Neutral Buffered Formalin.
Instructions
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Appropriate clinical history and surgical pathology report required. Mention cold Ischemia time, Time to fixation, Duration of fixation, Fixative used and Type of processing.
Note: For HER-2/neu: Time to fixation should be less than one hour (shorter the better). Duration of fixation should be more than 6 hrs and less than 48 hrs 152
for optimum results.
Fixative: 10% Neutral buffered formalin.
Transport Container
IHC specimen transport kit or slide folder. Biopsy in 10% NBF container with formalin as health hazard label sign.
Transport Temperature
Room temperature
Reject Criteria
Received refrigerated, Received frozen : Tissue biopsy received in fixative other than 10% Neutral Buffered Formalin. Samples with prior decalcification using strong slides.
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
As a prognostic and predictive marker in a case of diagnosed Ca Breast.
IHC-HLA DR with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Reacts with the alpha chain of monomeric HLA class II DR antigen and is valuable for analysing variations in class II expression, e.g. in B cell Non Hodgkin Lymphomas. The antibody also stains positive in AML-M3, AML-M6
IHC-HLA DR without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78754
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Monoclonal antibody originally identified from melanoma extract, recognizes melanosomal glycoprotein gp100. Used in confirmation of angiomyolipoma of kidney, melanomas (85-90%), soft part sarcomas.
IHC-HMB 45 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78878
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Reacts with the alpha chain of monomeric HLA class II DR antigen and is valuable for analysing variations in class II expression, e.g. in B cell Non Hodgkin Lymphomas. The antibody also stains positive in AML-M3, AML-M6
IHC-HMB 45 with Interpretation
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78885
78755
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Monoclonal antibody originally identified from melanoma extract, recognizes melanosomal glycoprotein gp100. Used in confirmation of angiomyolipoma of kidney, melanomas 153
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(85-90%), soft part sarcomas.
IHC-IgD with Interpretation 78843
Preferred Specimen(s)
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Instructions
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
Transport Container
IHC specimen transport kit or slide folder
Transport Temperature
Room temperature
Reject Criteria
Received frozen, broken slides, Insufficient tumor containing block
Methodology
Immunohistochemical Assay (IHC)
Clinical Significance
Human Immunoglobulin D (IgD) is present in the serum of normal individuals or of patients with Hodgkin’s disease (having high IgD concentrations). Useful in identifying leukemias, plasmacytomas and B-cell lineage-derived lymphomas (in particular marginal zone lymphoma).
IHC-IgD without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Human Immunoglobulin D (IgD) is present in the serum of normal individuals or of patients with Hodgkin’s disease (having high IgD concentrations). Useful in identifying leukemias, plasmacytomas and B-cell lineage-derived lymphomas (in particular marginal zone lymphoma).
IHC-INHIBIN with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
154
78864
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Inhibin is a heterodimeric protein (with alpha and beta subunits) that inhibits or activates pituitary gonadotrophins secretion particularly follicle stimulating hormone. A sensitive marker for majority of sex cord stromal tumors, including Sertoli cell tumors, adrenocortical
tumors, placental and gestational trophoblastic lesions, granular cell tumors of gallbladder and extrahepatic bile ducts.
IHC-INHIBIN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78844
78865
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Inhibin is a heterodimeric protein (with alpha and beta subunits) that inhibits or activates pituitary gonadotrophins secretion particularly follicle stimulating hormone. A sensitive marker for majority of sex cord stromal tumors, including Sertoli cell tumors, adrenocortical
tumors, placental and gestational trophoblastic lesions, granular cell tumors of gallbladder and extrahepatic bile ducts.
IHC-KAPPA Light Chains with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The presence of immunoglobulin light chains (kappa and lambda) on the cell surface is characteristic of clonal proliferation most often seen in multiple myeloma and lymphoproliferative diseases.
IHC-KAPPA Light Chains without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78722
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Ki-67 is a proliferation marker. It helps to guide patient prognosis & treatment response.
IHC-LAMBDA Light Chain with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78721
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Ki-67 is a proliferation marker. It helps to guide patient prognosis & treatment response.
IHC-Ki 67 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78807
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The presence of immunoglobulin light chains (kappa and lambda) on the cell surface is characteristic of clonal proliferation most often seen in multiple myeloma and lymphoproliferative diseases.
IHC-Ki 67 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78806
78775
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The presence of immunoglobulin light chains (kappa and lambda) on the cell surface is 155
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characteristic of clonal proliferation most often seen in multiple myeloma and
lymphoproliferative diseases.
IHC-LAMBDA Light Chain without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
The presence of immunoglobulin light chains (kappa and lambda) on the cell surface is characteristic of clonal proliferation most often seen in multiple myeloma and lymphoproliferative diseases.
IHC-MELAN A with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78859
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A protein which functions as one of the four major DNA mismatch repair genes and recombination pathway genes along with MSH2, PMS1 and PMS2. Mutations in the hMLH1 and hMLH2 genes contribute to the development of sporadic colorectal carcinoma and other hereditary and sporadic forms of human cancer.
IHC-MLH-1 without Interpretation 156
78745
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Expressed in skin, retina, majority of cultured melanocytes as well as in melanomas and
angiomyolipoma. Useful marker for identification of melanomas, and if melanomas are ruled out, for adrenocortical carcinomas and also angiomyolipomas.
IHC-MLH-1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78744
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Expressed in skin, retina, majority of cultured melanocytes as well as in melanomas and
angiomyolipoma. Useful marker for identification of melanomas, and if melanomas are ruled out, for adrenocortical carcinomas and also angiomyolipomas.
IHC-MELAN A without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78776
78860
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A protein which functions as one of the four major DNA mismatch repair genes and recombination pathway genes along with MSH2, PMS1 and PMS2. Mutations in the hMLH1 and hMLH2 genes contribute to the development of sporadic colorectal carcinoma and other hereditary and sporadic forms of human cancer.
IHC-MPO with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker can be used to aid in the diagnosis and/or prognosis of cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
IHC-MPO without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78856
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker can be used to aid in the diagnosis and/or prognosis of cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
IHC-MSH-2 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78855
78872
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
MSH2 is reported to be expressed in the nuclei of cells from a variety of tissues including ileum and colon, thyroid, heart, smooth muscle and the germinal centers of lymphoid follicles. Loss of MSH2 function leads to the accumulation of multiple mutations required for multistage carcinogenesis and have been linked to hereditary non polyposis colon cancer and to sporadic cancers which exhibit microsatellite instability.
IHC-MSH-2 without Interpretation 78873
157
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Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
MSH2 is reported to be expressed in the nuclei of cells from a variety of tissues including ileum and colon, thyroid, heart, smooth muscle and the germinal centers of lymphoid follicles. Loss of MSH2 function leads to the accumulation of multiple mutations required for multistage carcinogenesis and have been linked to hereditary non polyposis colon cancer and to sporadic cancers which exhibit microsatellite instability.
IHC-MUM1 with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Multiple myeloma oncogene-1 (MUM1) is a 50 kDa protein encoded by the MUM1 gene. IRF4/MUM-1 is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B cells located in the light zone. This assay identifies MUM1 protein in centrocytes and their progeny, plasma cells, activated T cells, and a wide spectrum of
hematolymphoid neoplasms derived from these cells. Therefore, this assay can be used as a powerful tool for the identification and the sub classification of lymphoid malignancies.
IHC-MUM1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
158
78788
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Multiple myeloma oncogene-1 (MUM1) is a 50 kDa protein encoded by the MUM1 gene. IRF4/MUM-1 is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B cells located in the light zone. This assay identifies MUM1 protein in centrocytes and their progeny, plasma cells, activated T cells, and a wide spectrum of
hematolymphoid neoplasms derived from these cells. Therefore, this assay can be used as a powerful tool for the identification and the sub classification of lymphoid malignancies.
IHC-MYO D1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78787
78752
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A nuclear phosphoprotein which induces myogenesis through transcriptional activation of muscle specific genes; is a sensitive marker of myogenic differentiation.Strongly labels the nuclei of myoblasts in developing skeletal muscle tissue whereas the majority of adult skeletal tissue is negative.
IHC-MYO D1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A nuclear phosphoprotein which induces myogenesis through transcriptional activation of muscle specific genes; is a sensitive marker of myogenic differentiation.Strongly labels the nuclei of myoblasts in developing skeletal muscle tissue whereas the majority of adult skeletal tissue is negative.
IHC-MYOGENIN with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78819
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker can be used to aid in the diagnosis and/or prognosis of cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
IHC-NSE without Interpretation Preferred Specimen(s)
Instructions
Transport Container
78772
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A myogenic transcriptional regulatory protein expressed early in skeletal muscle differentiation and essential for muscle development.Sensitive and specific for rhabdomyosarcoma and Wilm’s tumors.
IHC-NSE with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78771
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A myogenic transcriptional regulatory protein expressed early in skeletal muscle differentiation and essential for muscle development.Sensitive and specific for rhabdomyosarcoma and Wilm’s tumors.
IHC-MYOGENIN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78753
78820
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
159
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Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
This marker can be used to aid in the diagnosis and/or prognosis of cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
IHC-P504S (AMACR) with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
I
J
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
p504s is expressed in various normal tissues and carcinomas, while it is overexpressed over 30-fold in prostate carcinoma compared to benign glandular tissue; hence used in its diagnosis. Colorectal adenocarcinoma, high-grade prostatic intraepithelial neoplasia, atypical adenomatous hyperplasia and urothelial carcinoma may also express p504s
IHC-P504S (AMACR) without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
160
78710
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
p53 is a tumor suppressor gene. Mutations of the p53 gene are detectable in approximately half of all carcinomas. Detection of p53 by Immunohistochemistry serves as a surrogate marker of the mutant p53 gene. Generally, the presence of mutant p53 gene expression
is associated with a poorer prognosis.
IHC-P53 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78739
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
p504s is expressed in various normal tissues and carcinomas, while it is overexpressed over 30-fold in prostate carcinoma compared to benign glandular tissue; hence used in its diagnosis. Colorectal adenocarcinoma, high-grade prostatic intraepithelial neoplasia, atypical adenomatous hyperplasia and urothelial carcinoma may also express p504s.
IHC-P53 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78738
78711
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
p53 is a tumor suppressor gene. Mutations of the p53 gene are detectable in approximately half of all carcinomas. Detection of p53 by Immunohistochemistry serves as a surrogate marker of the mutant p53 gene. Generally, the presence of mutant p53 gene expression
is associated with a poorer prognosis.
IHC-PAX 5 (BSAP) with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Pax genes are a family of developmental control genes that encode nuclear transcription factors and have been implicated in the control of mammalian development. PAX-5 is a B cell speciric transcription factor that is expressed in pro B-cells, pre-B and mature B cells, and subsequently in all stages of B cell development until that plasma cell stage in which it is down regulated.
IHC-PAX 5 (BSAP) without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78712
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Normally detected in glycocalyx of fetal epithelial cells; Useful marker in diagnosing colorectal carcinoma, adenocarcinoma (lung) vs. epithelioid mesothelioma, Breast cancer vs. benign breast disease and Pancreatic adenocarcinoma. Differentiation between Cholangiocarcinoma and Hepatocellular carcinoma.
IHC-P-CEA without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78757
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Pax genes are a family of developmental control genes that encode nuclear transcription factors and have been implicated in the control of mammalian development. PAX-5 is a B cell speciric transcription factor that is expressed in pro B-cells, pre-B and mature B cells,
and subsequently in all stages of B cell development until that plasma cell stage in which it is down regulated.
IHC-P-CEA with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78756
78713
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report isrequired.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Normally detected in glycocalyx of fetal epithelial cells; Useful marker in diagnosing colorectal carcinoma, adenocarcinoma (lung) vs. epithelioid mesothelioma, Breast cancer vs. benign breast disease and Pancreatic adenocarcinoma. Differentiation between 161
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Cholangiocarcinoma and Hepatocellular carcinoma.
IHC-PLAP with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Detection of PLAP ( Placental Alkaline Phosphatase) is of great value in the evaluation of many different types of germ cell neoplasia, particularly seminomas and carcinomas of lung, stomach, pancreas, breast and ovary.
IHC-PLAP without Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78733
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A glycoprotein produced almost exclusively by prostatic epithelial and the epithlieal lining of periurethral glands.PSA is strongly expressed in both normal and neoplastic prostatic tissue hence the antibody is used to label prostatic carcinoma.
IHC-PTEN with Interpretation 162
78732
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A glycoprotein produced almost exclusively by prostatic epithelial and the epithlieal lining of periurethral glands. PSA is strongly expressed in both normal and neoplastic prostatic tissue hence the antibody is used to label prostatic carcinoma.
IHC-PSA without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78810
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Detection of PLAP ( Placental Alkaline Phosphatase) is of great value in the evaluation of many different types of germ cell neoplasia, particularly seminomas and carcinomas of lung, stomach, pancreas, breast and ovary.
IHC-PSA with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78777
78851
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A lipid phosphatase with tumor suppressor properties; has important role in cell cycle regulation and apoptosis.Reduced expression in seen in various malignancies including breast, prostate and endometrial cancers.
IHC-PTEN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A lipid phosphatase with tumor suppressor properties; has important role in cell cycle regulation and apoptosis.Reduced expression in seen in various malignancies including breast, prostate and endometrial cancers.
IHC-S100 with Interpretatation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78718
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Has wide distribution in human tissues including glia, neurons, chondrocytes, Schwann cells, melanocytes, mononuclear cells, Langerhan’s histiocytes, myoepithelial cells, notochord and various epithelia esp. in breast, salivary glands, sweat glands and female genital system. Crucial marker for malignanat melanoma; also important in Schwannonian, melanocytic and
chondrocytic tumors of soft tissue and bone and ovarian melanomas
IHC-SMA with Interpretation Preferred Specimen(s)
Instructions
78717
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Has wide distribution in human tissues including glia, neurons, chondrocytes, Schwann cells, melanocytes, mononuclear cells, Langerhan’s histiocytes, myoepithelial cells, notochord and various epithelia esp. in breast, salivary glands, sweat glands and female genital system. Crucial marker for malignanat melanoma; also important in Schwannonian, melanocytic and
chondrocytic tumors of soft tissue and bone and ovarian melanomas
IHC-S100 without Interpretatation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78852
78870
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
163
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Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Antibody to smooth muscle actin can be used to identify smooth muscle origin of sarcomas, and to identify myoepithelial cells of the breast.
IHC-SMA without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Antibody to smooth muscle actin can be used to identify smooth muscle origin of sarcomas, and to identify myoepithelial cells of the breast.
IHC-SYNAPTOPHYSIN with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
164
78716
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A calcium binding glycoprotein present in the membrane component of synaptic vessels.
A broad spectrum neuroendocrine marker and expressed in majority of neoplastic neuroendocrine cells and their equivalents in adrenal medulla, carotid body, skin, pituitary, thyroid, lungs, pancreas and gastrointestinal mucosa.
IHC-TDT with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78723
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
A calcium binding glycoprotein present in the membrane component of synaptic vessels. A broad spectrum neuroendocrine marker and expressed in majority of neoplastic neuroendocrine cells and their equivalents in adrenal medulla, carotid body, skin, pituitary, thyroid, lungs, pancreas and gastrointestinal mucosa.
IHC-SYNAPTOPHYSIN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78871
78791
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Terminal deoxynucleotidyl transferase is a nuclear DNA polymerase in thymic and small number of bone marrow cortical lymphocytes.Useful in diagnosis of acute lymphoblastic lymphoma (95%, diffuse strong), AML (5-10%, weak, focal).
IHC-TDT without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Terminal deoxynucleotidyl transferase is a nuclear DNA polymerase in thymic and small number of bone marrow cortical lymphocytes.Useful in diagnosis of acute lymphoblastic lymphoma (95%, diffuse strong), AML (5-10%, weak, focal).
IHC-THYROGLOBIN with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78796
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Also called CD141, thrombomodulin is an endothelial cell transmembrane glycoprotein. It has been used for the study of vascular tumors, and for the differentiation of mesothelioma from pulmonary adenocarcinoma
IHC-Thrombomodulin without Interpretation Preferred Specimen(s)
78861
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Large glycoprotein produced by thyroid follicular cells; later iodinated to form T3 and T4. Reacts with cells in normal, hyperplastic and neoplastic thyroid tissue; specific marker of thyroid differentiation.
IHC-Thrombomodulin with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78795
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Large glycoprotein produced by thyroid follicular cells; later iodinated to form T3 and T4. Reacts with cells in normal, hyperplastic and neoplastic thyroid tissue; specific marker of thyroid differentiation.
IHC-THYROGLOBIN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78792
78862
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
165
I
J
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
Also called CD141, thrombomodulin is an endothelial cell transmembrane glycoprotein. It has been used for the study of vascular tumors, and for the differentiation of mesothelioma from pulmonary adenocarcinoma
IHC-TTF-I with Interpretation I
J
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Selectively expressed during embryogenesis in the thyroid, the diencephalon of the brain and respiratory epithelium. Positive in thyroid and thyroid cancers regardless of histologic type and Lung cancers (adenocarcinomas-66%, large cell and small cell-95%)
IHC-TTF-I without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
166
78714
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
An intermediate filament protein which forms part of cytoskeleton of vertebrate cells; characteristically found in cells of mesenchymal origin.Expressed in a variety of normal cells/tissues and neoplastic lesions and is useful in identification of cells of mesenchymal
origin in normal and neoplastic tissues.
IHC-VIMENTIN without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78725
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
Selectively expressed during embryogenesis in the thyroid, the diencephalon of the brain and respiratory epithelium. Positive in thyroid and thyroid cancers regardless of histologic type and Lung cancers(adenocarcinomas-66%, large cell and small cell-95%)
IHC-VIMENTIN with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78724
78715
Formalin-fixed, paraffin-embedded tissue block, 4-micron unstained slides
Please indicate on the histology request form the name of the marker(s) requested.
Do not refrigerate or freeze. Pathology report is required.
IHC specimen transport kit or slide folder
Room temperature
Received refrigerated, Received frozen
Immunohistochemical Assay (IHC)
An intermediate filament protein which forms part of cytoskeleton of vertebrate cells; characteristically found in cells of mesenchymal origin.Expressed in a variety of normal cells/tissues and neoplastic lesions and is useful in identification of cells of mesenchymal
origin in normal and neoplastic tissues.
IHC-WT1 with Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A gene involved in the induction of Wilm’s tumor, a pediatric renal malignancy. WT1 overex
pression demonstrated in Wilm’s tumor, and in majority of mesotheliomas and acute leukemias; useful marker to differentiate ovarian carcinoma (WT1+) from breast/pancreatic
carcinoma (WT1-).
IHC-WT1 without Interpretation Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78823
10% neutral buffered Formalin-fixed, paraffin-embedded tissue block, 4-micron cut, 2 unstained section on positively charged Poly-L-Lysine/APES coated slides.
Ideal Fixation time for all Immunohistochemistry & Biopsy specimens is 6-72 Hrs in 10% neutral bufferred formalin as per CAP guidelines
IHC specimen transport kit or slide folder
Room temperature
Received frozen, broken slides, Insufficient tumor containing block
Immunohistochemical Assay (IHC)
A gene involved in the induction of Wilm’s tumor, a pediatric renal malignancy. WT1 overex
pression demonstrated in Wilm’s tumor, and in majority of mesotheliomas and acute leukemias; useful marker to differentiate ovarian carcinoma (WT1+) from breast/pancreatic
carcinoma (WT1-)
Immunoglobulin A (IgA), Serum Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78822
539
1.0 mL Serum
Overnight fasting is preferred.
Plastic Screw cap vial
Ambient 7 days, Refrigerated 14 days
Gross hemolysis, lipemic
Nephelometry
Approximately 1 in 1000 people have IgA deficiency. Individuals with low concentrations of IgA may be asymptomatic or have sinopulmonary, gastrointestinal (including sprue-like ill
ness), rheumatic, or autoimmune diseases.
Immunoglobulin E (IgE), Total, Serum - Serology
542
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic Screw cap vial
Transport Temperature
Refrigerated 1 week, -20oC Long term
Reject Criteria
Gross hemolysis, lipemic
MethodologyFEIA
Clinical Significance
IgE concentrations are increased with allergies (atopic disease), asthma, parasitic infections, unusual monoclonal gammopathies, and severe atopic dermatitis. IgE concentrations can be within the reference range with atopic disease. Individuals with low or low-normal concentra-
tions typically do not have atopic disease.
Immunoglobulin G (IgG), Serum Preferred Specimen(s)
Instruction
543
1.0 mL Serum
Overnight fasting is preferred
167
I
J
Transport Container
Plastic Screw cap vial
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis, lipemic
Methodology
Nephelometry
Clinical Significance
Patients with low concentrations of IgG may have a wide variety of respiratory illnesses including recurrent otitis media, sinusitis, pneumonia, chronic obstructive airway disease, bronchiectasis, and asthma. Measurement of IgG may be useful in monitoring patients being
treated for IgG monoclonal gammopathies and during replacement with intravenous immunoglobulins.
Immunoglobulin M (IgM), Serum Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
I
J
545
1.0 mL Serum
Overnight fasting is preferred.
Plastic Screw cap vial
Ambient 7 days, Refrigerated 14 days
Gross hemolysis, lipemic
Nephelometry
IgM is useful in diagnosing and monitoring patients with Waldenstrom’s macroglobinemia and other gammopathies.
Infertility Panel 1, Male 78528
Includes
TSH, FSH, Prolactin, Testosterone, Free and Total
Preferred Specimen(s)
3 mL serum
Transport Container
Sterile plastic screw-cap vial - Serum
Transport Temperature
Room Temperature
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyChemiluminescence
Clinical Significance
See individual test
Influenza A H1N1 Real Time RT PCR Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology Clinical Significance
79702
3.0 mL Nasal swab or Nasopharyngeal swab or Throat swab or Nasal aspirate in viral transport media.
Use only sterile swabs: Dacron®, nylon, or rayon with plastic shafts. DO NOT USE calcium alginate swabs.
Viral transport media vial
Refrigerated 15 days, Frozen 1 month
Sputum, Bronchial lavage, specimen containing alginate swab
Real-Time Reverse Transcriptase Polymerase Chain Reaction
Aid in the detection and differentiation of seasonal Influenza A virus infection and infection by the 2009 H1N1 influenza virus.
Inflammatory Bowel Disease
See “Inflammatory Bowel Disease Differential Panel”
Inhibin A 34472
Preferred Specimen(s)
1.0 mL Serum
Instruction
Specimens should be collected between the 14th and 22nd week of gestation. 15-16 weeks is the optimum time for testing.
Transport Container
Plastic Screw cap vial
Transport Temperature
Refrigerated 7 days
Reject Criteria
Gross hemolysis, lipemic
MethodologyEIA
Clinical Significance
Inhibin A is useful as an indicator of gonadal function, and ovarian response to hMg or to FSH stimulation. Inhibin A, produced by the placenta, is used along with other maternal serum biochemical markers to improve sensitivity of the screen for Down syndrome risk.
168
Insulin 561
Patient PreparationFasting
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Gross hemolysis • EDTA plasma • Grossly icteric
MethodologyChemiluminescence
Clinical Significance
For diagnosis and monitoring of diabetes and insulinsecreting tumors
Insulin-Like Growth Factor
See “IGF-I”
Insulin Response to Glucose, 120 min Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1.0 mL Serum or Heparinized plasma
Plastic Screw cap vial
Transport frozen
Unfrozen sample,Gross hemolysis, lipemic
Sandwich Chemiluminescent Immunoassay
The insulin response to glucose infusion is useful in evaluating patients with hypoglycemia and suspected insulin-resistance.
Integrated Panel 1 Includes
Test Components
79801
CBC with Peripheral smear ESR and Bone marrow examination
14645 - CBC with Peripheral smear
78685 - Bone marrow examination
See individual test for details
Integrated Panel 2 Includes
Test Components
78043
K
L
79802
CBC with Peripheral smear ESR, Bone marrow examination and Bone marrow biopsy with reticulin stain
14645 - CBC with Peripheral smear
78685 - Bone marrow examination
79199 - Bone marrow biopsy with reticulin stain
See individual test for details
Intrinsic Factor Blocking Antibody 568
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Grossly hemolysed
MethodologyImmunoassay
Clinical Significance
Intrinsic Factor, produced by cells lining the stomach, binds vitamin B12 (cyanocobalamin) to facilitate absorption of the vitamin. Blocking antibody impedes the action of Intrinsic Factor as observed in approximately half of the patients who develop pernicious anemia.
Iron, Total Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
571
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Gross hemolysis
Spectrophotometry (SP)
Serum measurements are useful in the diagnosis of iron deficiency and hemochromatosis
169
Iron, Total and Total Iron Binding Capacity Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Total Iron, Iron Binding Capacity, and % Saturation (calculated)
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Gross hemolysis
Spectrophotometry (SP)
Serum iron quantification is useful in confirming the diagnosis of iron-deficiency anemia or hemochromatosis. The measurement of total iron binding in the same specimen may facilitate the clinician’s ability to distinguish between low serum iron levels caused by iron
deficiency from those related to inflammatory neoplastic disorders. The assay for iron measures the amount of iron which is bound to transferrin. The total iron binding capacity (TIBC) measures the amount of iron that would appear in blood if all the transferrin were
saturated with iron. It is an indirect measurement of transferrin concentrations but expressed as an iron measurement. To obtain the percent saturation, the serum iron is divided by the TIBC which gives the actual amount of saturated transferrin. The percent
saturation is low in iron deficiency and high in iron storage diseases.
Lactate Dehydrogenase (LD) K
L
7573
593
Preferred Specimen(s)
1 mL serum
Instructions
Do not allow multiple freeze and thaw
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Received frozen • Anticoagulants other than heparin • Received refrigerated
MethodologySpectrophotometry
Clinical Significance
Elevations in serum lactate dehydrogenase occur from myocardial infarction, liver disease, pernicious and megaloblastic anemia, pulmonary emboli, malignancies, and muscular dystrophy
LD
See “Lactate Dehydrogenase (LD)”
LDH
See “Lactate Dehydrogenase (LD)”
LDL Cholesterol, Direct
See “Direct LDL”
LDL Sub Fraction
See “VAP® Cholesterol Test”
LH (Leuteinizing Hormone) Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
LH, FSH, and PRL Includes
Preferred Specimen(s)
Transport Container
170
615
1 mL serum (red top tube) no additive
Plastic screw-cap vial
Ambient 7 days, Refrigerated 14 days
Chemiluminescence
This test is useful in the differential diagnosis of pituitary and gonadal insufficiency and in children with precocious puberty
78529
Leuteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Prolactin (PRL)
4 mL serum from a red-top tube
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
• Serum: gross hemolysis or Hyperlipemic
MethodologyChemiluminescence
Clinical Significance
See Individual test
Lipase 606
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
Hemolysis • Lipemia
MethodologySpectrophotometry
Clinical Significance
Confirmatory evidence for diagnosis of pancreatitis
Lipid Fractionation
See “VAP® Cholesterol Test”
Lipid Panel with calculated LDL 7600
Includes
Triglycerides, Total Cholesterol, HDL-Cholesterol, LDL Cholesterol (calculated)
Patient Preparation
Patient should fast 8 hours prior to collection
Preferred Specimen(s)
3 mL serum
Instructions
Centrifuge within 30-60 minutes following collection
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
Reject CriteriaHemolysis
Methodology
See individual tests for methodologies
Clinical Significance
See Markers of Lipidemia in the Cardiovascular section of Test Application and Interpretation.
Lipid-Associated Sialic Acid (LSA,LASA) 8343
Preferred Specimen(s)
1 mL serum (red top tube ) no additive
Transport Container
Plastic screw-cap vial
Transport TemperatureRefrigerated
MethodologyImmunoprecipitin
Clinical Significance
This test is used to monitor tumor burden in patients with various malignant conditions, including Hodgkin’s Disease, leukemia, and melanoma. Increased levels are associated with breast cancer, colorectal cancer, gynecologic cancer, lung cancer, hematologic malignancies,
melanoma, and benign, inflammatory and chronic diseases. Decreased levels are associated with therapeutic response.
See Lipid Associated Sialic Acid (LASA, LSA) in the Hematology/Oncology section of Test Application and Interpretation.
Lipoprotein (a) 34604
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 14 days
Reject Criteria
Hyperlipemia, hemolysis
MethodologyImmunoturbidometric
Clinical Significance
Elevated concentrations of Lp(a) are associated with increased risk of coronary artery disease.
See Markers of Lipidemia in the Cardiovascular Tests section of Test Application and Interpretation.
Liver Kidney Microsomal (LKM-1) Antibody (IgG) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
15038
1 mL serum
Plastic screw-cap vial
Refrigerated (cold packs)
Gross hemolysis • Lipemic
171
M
N
MethodologyELISA
Clinical Significance
The presence of LKM-1 antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH-2)
Liver Panel
See “Hepatic Function Panel”
Lp (a)
See “Lipoprotein (a)”
MAG
See “Magnesium”
Magnesium 622
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Anticoagulants other than heparin
MethodologySpectrophotometry
Clinical Significance
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). Magnesium is decreased in chronic nephritis, acute pancreatitis, and alcoholic cirrhosis. It is increased in acute or chronic renal failure and Addison’s Disease.
Malaria and Blood Parasites M
N
831
Patient Preparation
Blood drawn 1 to 2 hours prior to expected chill will enhance recovery of malarial parasites by the laboratory
Preferred Specimen(s)
2-3 air-dried blood smears (1 thick and 1-2 thin) and a whole blood EDTA (lavender-top) tube
See Blood Parasites in the Parasites section of Specimen Collection and Handling for instructions
Transport Container
Slides in slide holders and an EDTA (lavender-top) tube
Transport Temperature
Room temperature
Reject Criteria
Hemolysis • Clotted
Methodology
Microscopic Examination
Clinical Significance
The identification of malarial parasites and other blood parasites is used to determine treatment and prognosis. One negative observation cannot rule out blood parasites. Babesia and other blood parasites are noted and reported.
See the Vector-Borne Diseases section in the Infectious Disease section of Test Application and Interpretation.
Malarial antigen detection 79022
Patient Preparation
Blood drawn 1 to 2 hours prior to expected chill will enhance recovery of malarial parasites by the laboratory
Preferred Specimen(s)
3 ml whole blood EDTA (lavender-top) tube
See Blood Parasites in the Parasites section of Specimen Collection and Handling for instructions
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Refrigerated 3 days
Reject Criteria
Hemolysis • Clotted
Methodology
Rapid card
Clinical Significance
The identification of malarial parasites and other blood parasites is used to determine treatment and prognosis.
See the Vector-Borne Diseases section in the Infectious Disease section of Test Application and Interpretation.
172
Marijuana Metabolites, GC/MS, Urine Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
30 mL random urine
Plastic screw-cap vial
Room temperature or Refrigerated
Gas Chromatography/Mass Spectrometry (GC/MS)
Marijuana Metabolite (50) (Cannabinoids / THC) Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78084
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Methaqualone, Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
4846
78086
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Maternal Serum Screen 1 (AFP), Second Trimester 78321
Includes
AFP and Maternal Risk Interpretation
Preferred Specimen(s)
1.0 mL serum
Instructions
Order using special requisition. A special requisition form designed to obtain patient data and the patient’s informed consent must be utilized when ordering the MSS1 test. Because MSS1 test results are influenced by certain patient characteristics, thefollowing data must be provided with the specimen in order to permit accurate interpretation of results: date of collection, patient’s (maternal) date of birth, patient’s estimated date ofdelivery, patient’s
weight, patient’s race, patient’s diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Grossly icteric
MethodologyChemiluminescence
Clinical Significance
Maternal serum Alpha-Fetoprotein (AFP) elevation is associated with an increased risk for open neural tube defects, multiple gestation, placental anomalies, ventral abdominal wall defects, congenital nephrosis and oligohydramnios. Follow-up for abnormal AFP results
include genetic counseling, level II or level III ultrasound examination and consideration of Amniocentesis for chromosome and AFP analysis. Normal level do not ensure birth of a normal infant; in addition, 2-3% of newborns have some type of physical or mental defects, many of
which may be undetectable with current prenatal diagnostics procedure.
Maternal Serum Screen 3 by using Prisca Software Includes
Preferred Specimen(s)
7292
AFP, unconjugated Estriol, hCG and Maternal Risk Interpretation
3 mL serum
173
M
N
Instructions
Order using special requisition. The Maternal Serum Screen 3 (MSS3) test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15-16 weeks. This time frame allows sufficient opportunity for further
diagnostic studies if the initial MSS3 test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open neural tube defects, Down syndrome or Trisomy 18. A special requisition form designed to obtain patient data and the patient’s informed consent must be utilized when ordering the MSS3 test. Because MSS3 test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of results: date of collection, patient’s (maternal) date of birth, patient’s estimated date of delivery, patient’s weight, patient’s race, patient’s diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Grossly icteric
MethodologyChemiluminescence
Clinical Significance
Maternal serum triple screen is used for prenatal screening for Down syndrome (Trisomy 21), Trisomy 18 (Edwards syndrome), and Open Neural Tube Defects (ONTD). This profile includes Alpha-Fetoprotein (AFP), unconjugated Estriol (uE3), and human Chorionic Gonadotropin (hCG). Establishing risk for fetal Down syndrome, using the triple creen achieves a 55-65% detection rate with a 5% false positive rate. Screening for Trisomy 18 detects 60% of affected fetuses with a 0.2% false positive rate. MSAFP screening detects
88% of anencephaly and 79% of open spina bifida with a 3% false positive rate. Normal results do not ensure birth of a normal infant. In addition, 2-3% of newborns have some type of physical or mental defect, many of which may be undetectable with current prenatal
diagnostic procedures.
Maternal Serum Screen 3 by using Maciel Software M
N
78322
Includes
AFP, unconjugated Estriol, hCG and Maternal Risk Interpretation
Preferred Specimen(s)
3.0 mL serum
Instructions
Order using special requisition. The Maternal Serum Screen 3 (MSS3) test in pregnant
women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15-16 weeks. This time frame allows sufficient opportunity for further diagnostic studies if the initial MSS3 test results are abnormal. Specimens submitted
before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open neural tube defects, Down syndrome or Trisomy 18. A special requisition form designed to obtain patient data and the patient’s informed consent must be utilized when ordering the MSS3 test. Because MSS3 test results are influenced by certain patient characteristics, the
following data must be provided with the specimen in order to permit accurate interpretation of results: date of collection, patient’s (maternal) date of birth, patient’s estimated date of delivery, patient’s weight, patient’s race, patient’s diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Grossly icteric
MethodologyChemiluminescence
Clinical Significance
Maternal serum triple screen is used for prenatal screening for Down syndrome (Trisomy 21), Trisomy 18 (Edwards syndrome), and Open Neural Tube Defects (ONTD). This profile includes Alpha-Fetoprotein (AFP), unconjugated Estriol (uE3), and human Chorionic Gonadotropin (hCG). Establishing risk for fetal Down syndrome, using the triple screen
achieves a 55-65% detection rate with a 5% false positive rate. Screening for Trisomy 18 detects 60% of affected fetuses with a 0.2% false positive rate. MSAFP screening detects 88% of anencephaly and 79% of open spina bifida with a 3% false positive rate. Normal results do not ensure birth of a normal infant. In addition, 2-3% of newborns have some type of physical or mental defect, many of which may be undetectable with current prenatal diagnostic procedures.
Maternal Serum Screen 4 (Quad Screen by using Maciel Software) 174
78324
Includes
AFP, unconjugated Estriol, hCG, Dimeric Inhibin A, and Maternal Risk Interpretation
Preferred Specimen(s)
3 mL serum
Instructions
Order using special requisition. Room temperature specimens must be received within 48 hours of collection. The Maternal Serum Screen 4 (MSS4) test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal
period is 15-16 weeks. This time frame allows sufficient opportunity for further diagnostic studies if the initial MSS4 test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open neural tube defects, Down syndrome or Trisomy 18. A special requisition form designed to obtain patient data and the patient’s informed consent must be utilized when ordering the MSS4 test. Because MSS4 test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of results: date
of collection, patient’s (maternal) date of birth, patient’s estimated date of delivery, patient’s weight, patient’s race, patient’s diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 3 days, Refrigerated (cold packs) 7 days
Reject Criteria
Gross hemolysis • Gross lipemia • Grossly icteric
MethodologyChemiluminescence
Clinical Significance
Maternal Serum Screen 4 is used for prenatal screening of Down syndrome (Trisomy 21), Trisomy 18 (Edwards syndrome), and open neural tube defects (ONTD). This profile includes alpha-fetaprotein (AFP), unconjugated estriol (uE3), human chorionic gonadotropin (hCG), and inhibin A. Establishing risk for fetal Down syndrome, using the quad screen achieves a 70-75% detection rate with a 5% false positive rate. Screening for Trisomy 18 detects 60% of affected fetuses with a 0.2% false positive rate. MSAFP screening detects 88% of anencephaly and 79% of open spina bifida with a 3% false positive rate. Normal results do not ensure birth of a normal infant. In addition, 2-3% of newborns have some type of physical or mental defect, many of which may be undetectable with current prenatal diagnostic procedures.
Methadone, Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78085
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Metanephrines, Fractionated, Plasma 15920
Includes
Metanephrine, Normetanephrine, and Total Metanephrine
Patient Preparation
Patient should avoid alcohol, coffee, tea, tobacco and strenuous exercise before collection. Overnight fasting is preferred. Patient should be relaxed in either a supine or upright position before blood is drawn.
Preferred Specimen(s)
2 mL plasma collected in a pre-chilled EDTA (lavendertop) tube
Instructions
The whole blood sample should be kept on wet ice until centrifuged (preferably at 4° C) to separate the plasma within 2 hours of venipuncture. After centrifugation, the plasma should be transferred to a plastic, leakproof vial and immediately frozen.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Heparinized plasma • Serum • CSF • Room temperature urine
Methodology
High Performance Liquid Chromatography (HPLC) • Electrochemical Detection
Clinical Significance
Normetanephrine (NM) and metanephrine (MN) are the extra-neuronal catechol-o-methyl transferase (COMT) metabolites of the catecholamines norepinephrine and epinephrine, respectively. Measurement of plasma metanephrines is more sensitive (but may be less
specific) than measurement of catecholamines for the detection of pheochromocytoma. 175
M
N
Proper interpretation of results requires awareness of recent medication/drug history (e.g., antihypertensive agents, alcohol, cocaine) and other pre-analytical factors (e.g., stress,
severe congestive heart failure, myocardial infarction) that influence release of catecholamines and metanephrines.
Microalbuminuria, 24Hrs urine 78576
Preferred Specimen(s)
5.0 mL 24 hour urine - no preservative
Instruction
Submit 5.0 mL aliquot from a well-mixed 24-hour, submitted in a plastic, leak-proof container. Do not use preservatives. Record 24-hour urine volume on test request form and urine vial.
Transport Container
Plastic leak proof container
Transport TemperatureRefrigerated
Reject CriteriaFrozen
MethodologySpectrophotometry
Clinical Significance
Microalbumin is albumin excreted in the urine and is a sensitive marker of nephropathy. It is used to screen for early renal disease in diabetic patients.
Microalbumin, Random Urine with Creatinine 6517
Preferred Specimen(s)
10 mL random urine - no preservative
Transport Container
Plastic screw-cap vial
Transport TemperatureRefrigerated
MethodologySpectrophotometry
Clinical Significance
See Microalbumin, Urine in the Chronic Kidney Disease section of Test Application and Interpretation.
Microfilaria Detection 10060
This test is appropriate if the suspected microfilaria is wucheria bancrofti, loa loa, Brugia malayi, Brugia timori, Mansonella perstaris, or Mansonella ozzardi.
M
N
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
3 mL whole blood, Slide smear
Store the slide in the slide box only after the smear has dried up.
EDTA vial (lavender-top) tube, Slide box
Room temperature
Received frozen
Geimsa Stain, Microscopic Examination
Detection of microfilariae in blood was the standard approach to diagnosing lymphatic filarial infection (or loiasis), and it is the one still required today for both brugian filariasis and those situations where the antigen detection test is not available for bancroftian filariasis.
Micrometastasis Detection in Lymph Nodes Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
12740
Formalin-fixed, paraffin embedded tissue block
Pathology report is required
Paraffin block bag
Room temperature
Received frozen
Immunohistochemical Assay (IHC)
This test is used to detect micrometastases of epithelial cell origin (e.g., breast cancer), determine the stage of epithelial cancers, and to predict cancer recurrence/relapse and diminished overall survival. A positive result indicates the presence cytokeratin-positive cells suggestive of micrometastasis.
See Micrometastasis Detection, IHC, Lymph Node or Bone Marrow in the Hematology/
Oncology section of Test Application and Interpretation.
MPO
See “Myeloperoxidase Antibody (MPO)”
Mumps Antibody Panel (IgG, IgM) 176
36564
Preferred Specimen(s)
1 mL serum
Instructions
Allow specimen to clot at room temperature and then centrifuge. Separate serum from cells as soon as possible. Refrigerate at 2-8° C.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
MethodologyImmunoassay
Mycobacterium Tuberculosis 1st line drug (RIF/INH) Sensitivity assay by Hains (Rapid) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79552
Pulmonary samples, Growth from appropriate solid media, such as Lowenstein-Jensen slants, Growth in Middlebrook 7H9 broth such as the MB (Blood) culture bottle.
Sterile Plastic Container, Culture Vial
Room Temperature 48 hrs, Refrigerated 7 days
Sample submitted in non-sterile container, uncapped or broken containers; quantity not sufficient specimens; Specimens exceeding stability.
PCR, Line Probe Assay
The test is based on line probe technology and permits the molecular genetic identification of the M.tuberculosis complex (M.tuberculosis, M.bovis.bovis, M.bovis BCG, M.bovis.caprae, M.africanum and M.microtii) and its resistance to rifampicin and/or isoniazid.
Mycobacterium Tuberculosis 2nd line drug (Ofloxacin, 79553
Levoflxacin, Moxifloxacin, ciprofloxacin, Amikacin, Kanamycin & Capreomycin) sensitivity by Hains (Rapid)
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Smear positive pulmonary samples, Growth from appropriate solid media, such as Lowenstein-Jensen slants, Growth in Middlebrook 7H9 broth such as the MB (Blood) culture bottle.
Sterile Plastic Container, Culture Vial
Room Temperature 48 hrs, Refrigerated 7 days
Sample submitted in non-sterile container, uncapped or broken containers; quantity not sufficient specimens; Specimens exceeding stability.
Line Probe Assay
This is used for the detection of fluoroquinolone and amikacin/capreomycin resistance and to a lesser extent also ethambutol resistance. In combination with a molecular test for detection of rifampin and isoniazid resistance, the potential for the detection of extensively
resistant tuberculosis within 1 to 2 days can be postulated.
Mycobacterium tuberculosis Complex, PCR, Non-Respiratory Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
3 mL CSF or 6 mL body fluid or urine or 2 g tissue
Tissue: Collect aseptically as much as possible, up to 2 grams. Specimen must be kept moist with transport media, saline, broth or buffer. Tissues fixed in formalin or paraffin blocks are not acceptable. Fluids: Collect aseptically as much as possible, up to 150 mL. Gastric lavage fluids: Collect 5-10 mL of an early morning specimen, before food or water intake, in a sterile container without preservative. Adjust to normal pH with 100 mg of sodium carbonate within 4 hours of collection. Unneutralized specimens are not acceptable.
Separate specimens collected on 3 consecutive days are recommended.
Plastic screw-cap leak proof container, for blood use lavender top EDTA tube
Refrigerated (cold packs) 5 days
Received room temperature
Polymerase Chain Reaction (PCR)
This is an amplified method used to detect Mycobacterium tuberculosis complex nucleic acid in the raw specimen. It is used to aid the physician in the rapid diagnosis and treatment of a possible tuberculosis infection. A negative result does not rule out disease.
Results should be supported by additional alternate testing.
Mycobacterium tuberculosis Complex, PCR, Respiratory Preferred Specimen(s)
30277
30298
7 mL sputum or bronchial lavage/wash or tracheal lavage/wash
177
M
N
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Collect first morning specimen for three consecutive days. Use standard tube-in-cylinder collection kit or submit in sterile, plastic container with leak-proof cap. Keep refrigerated.
Plastic screw-cap vial
Refrigerated (cold packs) 5 days
Received room temperature
Polymerase Chain Reaction (PCR)
Mycobacterium tuberculosis Drug Sensitivity (5 Drugs) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Pure culture on a suitable mycobacterial medium suchas Lowenstein-Jensen agar slant, MGIT 7ml, MB BactT bottles
Along with the growth, the antibiotics required to be tested for are to be mentioned. The antibiotics available are: INH, Rifampicin, Streptomicin, pyrazinamide, and ethambutol. Test may require up to eight weeks to report.
See Transport of Bacterial Isolates in the Bacteriology section
Room temperature
Non-viable isolates
Rapid Automated Fluroscent Technique
Susceptibility reports can be used as a guide in the choice of first course therapy or in confirming antimicrobial resistance that leads to a further course of treatment. Aggregate data may be used to estimate the prevalence of primary and acquired antimicrobial
resistance in a community.
Mycobacterium tuberculosis Drug Sensitivity (8 Drugs) M
N
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
178
10526
If culture is positive,identification will be performed. Antibiotic susceptibilitiesare only performed when appropriate.
BD Myco F- lytic bottles( Preferred) SPS (yellow-top) tube, Sodium heparin (green-top) tube.
Specimens should be delivered to the laboratory within one day of collection
• Sodium heparin (green-top) tube • Isostat® isolator tube (not provided by laboratory)
Room temperature 48 hrs
Blood or bone marrow in EDTA tube
MGIT 960
Isolation and identification of mycobacteria is important for the management and treatment of tuberculosis and other mycobacterial diseases.
Mycobacterium, Culture Includes
Preferred Specimen(s)
Instructions
79524
Pure culture on a suitable mycobacterial medium suchas Lowenstein-Jensen agar slant, MGIT 7ml, MB BactT bottles
Along with the growth, the antibiotics required to betested for are to be mentioned. The antibiotics available are: amikacin, capreomycin, kanamycin, ofloxacin, ciprofloxacin, levofloxacin, PAS, Ethionamide.
See Transport of Bacterial Isolates in the Bacteriology section
Room temperature
Non-viable isolates
Rapid Automated Fluroscent Technique
Susceptibility reports can be used as a guide in the choice of first course therapy or in confirming antimicrobial resistance that leads to a further course of treatment. Aggregate data may be used to estimate the prevalence of primary and acquired antimicrobial
resistance in a community.
Mycobacterium, Blood Culture
Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78545
4554
Acid fast stain, Mycobacterium culture, Concentration If culture is positive, identification will be performed at an additional charge.
Sputum: Collect three separate first morning deepcough sputum specimens for three consecutive days. Submit each specimen immediately following collection.
Specimens of gastric aspirates should be neutralized with 1 gm of sodium carbonate per 15 mL of specimen before transport to the laboratory. Specimens should be delivered to the Transport Container
Transport Temperature
Reject Criteria
Methodology
laboratory within one day of collection.
See Specimen Collection section for general site specific instructions.
Sterile plastic screw-capped tube
Note: Blood should be transported in sodium heparinized (green-top) tubes or tubes with SPS anticoagulant (yellow-top) tubes.
Room temperature 48 hrs, Refrigerated 5 days
Swab transport medium >5 days old • Dry swabs • Expired swab transport medium or port-a-cul medium • Specimen received in formalin and/or alcohol • Raw specimens >5 days old • A bagged specimen that has leaked out and contaminated
the exterior of the container • 24-hour pooled sputum or urine specimens • Urine received in Boricon tube • Frozen samples • Broken slides
MGIT 960
Mycobacterium Tuberculosis RT-PCR Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79277
2.0 mL sputum, BAL , Bronchi Wash, urine, pleural fluid;1.0 mL CSF
Sputum: collect in a sputum collection kit or a sterile, plastic container with a leak-proof cap.
BAL, Bronchi Wash, pleural fluid, CSF and Urine: Collect in a sterile, plastic container with a leak-proof cap.
Whole Blood or bone marrow: Collect in sterile tubes with EDTA as an anticoagulant.
Refrigerated 5 days, -20oC for extracted DNA 30 days
Specimens containing heparin;?specimens with calcium alginate swabs; Samples from leaking, uncapped or broken containers; quantity not sufficient specimens; Specimens exceeding stability.
Real Time PCR ABI 7500 Fast
Tuberculosis is a widespread disease, with over 20,000 new cases being reported annually in the United States, in addition to the over 10 million people already infected. Although presumptive diagnosis of tuberculosis can be made on the basis of patient histories, clinical and radiological findings, and the presence of acid-fast bacilli in patient specimens, the
isolation of the etiologic agent is required for the definitive diagnosis of tuberculosis. Disease in humans is caused by both M. tuberculosis and M. bovis, which are members of the M. tuberculosis complex (which also includes M. africanum, M.microti, and M. canettii).
The most significant route of infection is via a respiratory route, generally resulting in pulmonary tuberculosis. Extrapulmonary disease can occur following dissemination of the organism, and it may manifest itself as abdominal, CNS, joint, or bone disease (among
others). Because of the morbidity associated with disease and the possibility for the spread of this disease, a rapid clinical diagnosis is required. Although presumptive diagnosis of tuberculosis can be made on the basis of patient histories, clinical and radiological findings, and the presence of acid-fast bacilli in patient specimens, the isolation of Mycobacterium tuberculosis is required for the definitive diagnosis of tuberculosis. Routine cultures are cumbersome and time-consuming. For that reason, the development of a more rapid
method for diagnosis is highly desirable. PCR amplification and detection of Mycobacterial DNA has proved to be such a method. It is highly specific, and sensitivity can be greater than that of culture, which is considered to be the gold standard. A negative PCR indicates the
absence of M. tuberculosis DNA in the sample tested, and it does not exclude the diagnosis of M. tuberculosis related diseases.
If culture is positive, identification will be performed
Native DNA
See “DNA (ds) Antibodies”
Neisseria gonorrhoeae (GC), Culture Includes
Preferred Specimen(s)
Instructions
480
If culture is positive, identification will be performed at an additional charge. Antibiotic susceptibilities are only performed when appropriate.
Urethral, cervical, anorectal or throat. Collect specimen using a blue-cap, Amies gel transport medium swab delivered within 24 hours of collection.
See Neisseria gonorrhoeae Culture in the Bacteria section of Specimen Collection and Handling for instructions.
Deliver to the Microbiology lab ASAP transport swab Do not refrigerate. Indicate source of 179
M
N
specimen on both the requisition and specimen collection device. For blood specimens, use test “Culture, Blood”. For sterile body fluids, use test “Culture, Aerobic and Anaerobic”.
Transport Container
Copan transport swab containing Amies gel medium
Transport Temperature
Room temperature 48 hrs
Reject Criteria
Expired transport swabs • Specimens >24 hours old • Received frozen
Methodology
Conventional Culture,Microscopic & Automation
Clinical Significance
Neisseria gonorrhoeae is considered a pathogen whenever isolated and its identification is important in initiating appropriate therapy to prevent the spread of the infection as well as the serious sequelae.
See Prevention of Pelvic Inflammatory Disease (PID): Screening for Chlamydia trachomatis and Neisseria gonorrhoeae in the Infectious Disease section of Test Application and Interpretation.
Neisseria gonorrhoeae Smear Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Urethral swab/ Vaginal discharge/ Throat swab
Collect with sterile swab
Stuart Medium tube with swab
Room temperature 10 days for dried smear, 2 days for specimen swab
Incorrect labelling, insufficient and spoiled sample; frozen
Microscopic Examination
A GC smear (gonococcus smear) is a gram stain of urethral exudates in men and endocervical secretions in women and can be part of a presumptive diagnosis of gonorrhea. One looks for gram-negative diplococci with flattened adjacent walls that are seen both inside and outside of polymorphonuclear leukocytes. This test is quite sensitive in symptomatic males but only 40-60% sensitive in symptomatic females.In asymptomatic males and females the gram stain has a lower predictive value.
Neuron Specific Enolase (NSE) O
P
79025
34476
Preferred Specimen(s)
1 mL serum
Instructions
NSE is high in platelets and RBC; therefore, plasma and hemolyzed specimens are not acceptable
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Plasma • Hemolysis
Methodology
Enzyme Immunoassay
Clinical Significance
This test is used to monitor disease progression and therapy in individuals with small cell lung cancer (SCLC) and in other cancers (e.g., prostate).
See Tumor Markers in the Hematology/Oncology section of Test Application and Interpretation.
NMP-22™
See “Nuclear Matrix Proteins (NMP-22®)”
Non-Gynaecologic Cytology 10676
Preferred Specimen(s)
Body fluids FNAC specimen, smeared on to four glass slides and air dried.
Instruction
Collection requirements differ greatly depending on the type and source of the submitted sample. Provide all patient information using the Cytology test requisition. Prefer Non gynecologic specimens in section Cytology of specimen collection and handling.
Transport Container
Fluid: Fluid is collected in sterile vacuum bottle or other collection container and then aliquoted as needed into lavender top (EDTA), green top (Heparin), or red top (unpreserved) tube.
Transport Temperature
Fluid- Refrigerated;
Reject Criteria
Slide broken in transit beyond our ability to repair • Unlabeled container or slide • Leakage of fluid during transport • Mismatch between name of patient on slide and name on test 180
requisition
Methodology
Microscopy
Clinical Significance
The nature of possible underlying disease states including cancer or infections can often be detected by microscopically visualizing cytological changes in cells which are exfoliated and captured by fluid extraction from body cavity, brushings, washings, or fine needle aspirations.
Nuclear Matrix Proteins (NMP-22®) 34099
Preferred Specimen(s)
10 mL urine collected in a Matritech NMP-22® collection kit
Instructions
One random urine sample should be collected and stabilized immediately, by the patient or medical personnel, using the Matritech (NMP-22®) urine collection kit. Contact your local client services department to obtain this kit. All other collection methods are unacceptable. Stabilized samples should be stored at 2-8° C for up to one week or frozen at -80° C.
Transport Container
Matritech NMP-22® collection kit
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Received room temperature • Collected in any device other than Matritech NMP-22®
MethodologyImmunoassay
Clinical Significance
NMP-22® is involved in DNA replication. NMP-22® is increased in patients with bladder carcinomas. NMP-22® appears to be more sensitive and specific for lowgrade bladder cancers than urine cytology alone. See Bladder Cancer in the Hematology/Oncology
section of Test Application and Interpretation.
O and P with Permanent Stain
See “Ova and Parasites”
Occult Blood
See “Fecal Globin by Immunochemistry (InSure®)”
Occult Blood Stool Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79033
2.0 gm Stool
Fasting not applicable. For at least two days before and during the test period all raw meat and red meat should be avoided. Raw broccoli, cauliflower, radishes and turnips may cause false positive results, hence should be avoided. For occult blood tests certain medications
such as aspirin, indomethcin, phenylbutazone, reserpine, corticosteroids and non-steroidal anti-inflammatory drugs can induce gastrointestinal bleeding. Vitamin-C and iron containing medication should be discontinued for two days before and during the test period with the consent of the physician. The stool samples should be collected from different areas of the formed stool.
Sterile Plastic Screw cap vial
Room Temperature 48 hrs
Stool submitted in non-sterile container
SG Method
Fecal occult blood test that qualitatively detects human hemoglobin from blood in fecal samples. This is a useful screening aid for detecting primarily lower gastrointestinal(G.I.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other G.I. lesions that can bleed. It is recommended for use by health professionals as part of routine physical examinations and in screening for colorectal cancer or other sources of lower G.I. bleeding.
Opiates, Clinical Screen with Confirmation Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
30470
Codeine, Hydrocodone, Hydromorphone, Morphine, Opiates
10 mL random urine
Plastic urine container
Ambient 7 days, Refrigerated 14 days
Urine with preservative
181
O
P
Methodology
Clinical Significance
Spectroscopy
Opiates are detected by EMIT® and individual drugs are confirmed (codeine, morphine). Codeine metabolizes to morphine. Hydrocodone metabolizes to hydromorphone. All four drugs are controlled drugs. Morphine may also be present from heroin and poppy seed ingestion. Presence of drug in the urine indicates prior exposure to the drug.
Opiates, Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78087
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine
Ovarian Dysfunction Assessment Panel 78539
Includes
(LH FSH, PRL, TSH, E2) Day 3 to Day 5
Preferred Specimen(s)
4 mL serum from a no additive (red-top tube)
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
Reject Criteria
EDTA with hemolysis or received frozen or clotted • Serum: gross hemolysis or Hyperlipemic • Frozen or stored Urine
MethodologyChemiluminescence
Clinical Significance
See Individual test
OVA-1
O
P
Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
Additional Information
79841
Beta-2 Microglobulin, Apolipoprotein-A1, Transferrin, Prealbumin, CA-125
2.0 mL Serum
Plastic screw-cap vial
Refrigerated, Stable for 7 days
Nephelometry, Electrochemiluminescence
The OVA1 test is based on a proprietary FDA-cleared software device that combines the results of five biomarker assays in to a single numerical result (The results of Beta-2 microglobulin, Transferrin, Prealbumin, Apolipoprotein A1 and CA 125. These tests should be ordered independently if clinically indicated.
Intended use of OVA1: The OVA1 test is qualitative serum test that combines the results of 5 immunoassays in to a single numerical result. It is indicated for women who meet the following criteria; Over age 18 years, ovarian adenexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy.
PAI-1
See “Plasminogen Activator Inhibitor (PAI-1)”
PAI-1 (Plasminogen Activator Inhibitor-1)
See “Plasminogen Activator Inhibitor (PAI-1)”
Pap 1 Slide (Pap conventional) Includes
182
3526
Pap results requiring physician interpretation will be performed. If concurrent testing for HPV is desired then, a separately obtained swab must be obtained and separately ordered. HPV Reflex testing is not available with Conventional Pap Smear orders.
Preferred Specimen(s)
Instructions
Reject Criteria
Methodology
Clinical Significance
One smear fixed immediately with spray fixative or 95% ethyl alcohol
See Gynecologic Specimens: The “Pap” Test in the Cytology section of Specimen Collection and Handling
Includes Pap results requiring physician interpretation will be performed. If concurrent testing for HPV is desired then, a separately obtained thinprep vial must be obtained and separately ordered. HPV Reflex testing is not available with Conventional Pap Smear orders.
Slide broken in transit beyond our ability to repair • Unlabeled slide (labels on the slide carrier are not acceptable) • Mismatch between name of patient on slide and name on test requisition
Microscopy
The Conventional Pap Smear is intended for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as defined by The Bethesda System 2001 for Reporting Cervical/Vaginal Cytologic Diagnoses. Not reliable for endometrial screening.
Pap, Liquid-Based
See “ThinPap® Pap”
Pap Test By Liquid Based Cytology (LBC) 35455
Preferred Specimen(s)
Provide all patient information using the Cytology test requisition.
See Gynecologic Specimens: The “Pap” Test in the Cytology section of Specimen Collection and Handling. Specimen to be collected in thin prep vial using brush
Transport Container
Thin Prep Vial
Transport Temperature
Room temperature
Reject Criteria
See Unacceptable Specimens with General Submission Requirements in the Cytology section of Specimen Collection and Handling.
Methodology
Microscopy
Clinical Significance
Liquid-based Pap Testing is intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Results of Cervical Cytology. Pap screening is not reliable for the detection of endometrial cancer. Gynecologic cytology is a screening test which is
subject to both false positive and false negative results. For that reason, the test is most reliable when a satisfactory sample is obtained on a regular repetitive basis. Hence, these results must be interpreted in the context of historic and current clinical information.
See Cervical Cancer in the Hematology/Oncology section of Interpretive Information.
Pap Test By LBC Without Interpretation 35456
Preferred Specimen(s)
Provide all patient information using the Cytology test requisition.
See Gynecologic Specimens: The “Pap” Test in the Cytology section of Specimen Collection and Handling.
Transport Container
Thin Prep Vial
Transport Temperature
Room temperature
Reject Criteria
See Unacceptable Specimens with General Submission Requirements in the Cytology section of Specimen Collection and Handling.
Methodology
Microscopy
Clinical Significance
Liquid-based Pap Testing is intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System 2001 for Reporting Results of Cervical Cytology. Pap screening is not reliable for the detection of endometrial cancer. Gynecologic cytology is a screening test which is
subject to both false positive and false negative results. For that reason, the test is most reliable when a satisfactory sample is obtained on a regular repetitive basis.
Pap Test By Liquid Based Cytology & High Risk HPV DNA Includes
Preferred Specimen(s)
78990
Thin Prep Pap with HPV
Provide all patient information using the Cytology test requisition.
See Gynecologic Specimens: The “Pap” Test in the Cytology section of Specimen Collection and Handling.
Specimen to be collected in thin prep vial using brush
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Transport Container
Thin Prep Vial
Transport Temperature
Room temperature
Reject Criteria
See Unacceptable Specimens with General Submission Requirements in the Cytology section of Specimen Collection and Handling.
Methodology
Microscopy • Third wave technology invader signal amplification detection
Clinical Significance
Liquid-based Pap Testing is intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as define by The Bethesda System for Reporting Results of Cervical Cytology. Pap screening is not reliable for the detection of endometrial cancer. Gynecologic cytology is a screening test which is subject to both false positive and false negative results. For that reason, the test is most reliable when a satisfactory sample is obtained on a regular repetitive basis. Hence, these results must be interpreted in the context of historic and current clinical information. HPV is the causative agent for cervical dysplasia and cervical cancer. HPV DNA testing in conjunction with a Pap test in women 30 years and older can be used adjunctively to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The use of this test has not been evaluated for the management of women with prior cytologic or histologic abnormalities, hysterectomy, who are postmenopausal, or who have other risk factors (e.g., HIV+, immune-compromised, DES exposure, history of STD).
Partial Thromboplastin Time, Activated (aPTT) O
P
763
Preferred Specimen(s)
3.2% sodium citrate (light blue-top) tube
Instructions
Correct ratio of blood to citrate is critical (9:1). Do not overfill or underfill collection tube. Mix by inversion 4 times. For non-heparinized patients, maintain specimen at room temperature. Do not uncap. Stable 24 hours at room temperature. For heparinized patients or if testing will be delayed longer than 24 hours, centrifuge specimen within 1 hour of collection at 1500 RCF (relative centrifugal force) for 15 minutes. Transfer plasma to a
plastic screw-cap vial and freeze at -20° C immediately.
Transport Container
Whole blood: 3.2% sodium citrate (light blue-top) tube
Plasma: Plastic screw-cap vial (frozen)
Transport Temperature
Room temperature: (Light blue-top) tube - whole blood (if specimen sent to laboratory within 4 hours of collection)
Frozen: Plasma
Reject Criteria
Gross hemolysis • Improper blood to citrate ratio • Clotted • Age of specimen • High hematocrits
Methodology
Clotting method
Clinical Significance
Screening test for deficiencies of plasma coagulation factors other than Factors VII and XIII. The test is also used to monitor patients on heparin therapy.
Penta Screen
See “Maternal Serum Screen 5”
Periodic Acid Schiff (PAS) Stain Preferred Specimen(s)
Transport Container
Transport Temperature
184
Tissue section/paraffin embedded block
Fluid: Plastic screw-cap vial
Tissue section: Slide mailer
Tissue: 10% Formalin
Paraffin embedded block
Tissue 10% bufferred formalin : Ambient
70012
Reject Criteria
Methodology
Clinical Significance
Paraffin Embedded block : Ambient
Poorly preserved tissue/Poorly processed paraffin block
Microscopic Examination
This method is primarily used to identify glycogen in tissues. The reaction of periodic acid selectively oxidizes the glucose residues, creates aldehydes that react with the Schiff reagent and creates a purple magenta color. A suitable basic stain is often used as a counter-stain. PAS staining is mainly used for staining structures containing a high proportion of carbohydrate macromolecules (glycogen, glycoprotein, proteoglycans), typically found in, e.g., connective tissues, mucus, and basal laminae. PAS staining can be used to distinguish between different types of glycogen storage disease.
Peripheral Blood Smear 833
Preferred Specimen(s)
2ml whole blood in EDTA vial, slide (1 fresh smear)
Instructions
Place the slide carefully in the slide box after the smear is dry.
Transport Container
EDTA vial (lavender-top) tube, slide box
Transport Temperature
Room temperature, stable 48 hours
Reject Criteria
Received frozen; broken slide
Methodology
Microscopic Examination
Clinical Significance
The peripheral blood smear may be useful to describe morphologic abnormalities and leukemias.
Phenytoin 79072
Patient Preparation
Collect as a trough just prior to next dose. For patients receiving phenytoin therapy, collect as a trough at least 2 hours after IV infusion or at least 4 hours after IM injection.
Preferred Specimen(s)
1 mL serum collected in a (red-top) tube (no gel)
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 8 hrs, Refrigerated 2 days
Reject Criteria
Serum separator tube (SST®)
MethodologyImmunoassay
Clinical Significance
Phenytoin is an anticonvulsant hydantoin used for the treatment of generalized tonic-clonic (grand mal) and complex partial seizures. Phenytoin is also used for prophylaxis in neurosurgical procedures. Phenytoin levels are monitored to assure adequate therapeutic
levels are achieved and to avoid toxicity. See Drug Half-life, Steady State, and Recommended
Sample Collection Time in the Toxicology section of Test Application and Interpretation.
Phosphate 718
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Plasma
MethodologySpectrophotometry
Clinical Significance
Serum phosphorus (phosphate) levels alone are of limited diagnostic value and should be correlated with serum calcium levels. An increased phosphorus with decreased calcium suggests either hypoparathyroidism or renal disease. A decreased phosphorus and an
increased calcium suggests hyperparathyroidism or sarcoidosis. When both calcium and phosphorus are decreased diagnostic considerations include malabsorption, vitamin D deficiency and renal tubular acidosis. Increased phosphorus and normal or increased calcium suggests Milk-alkali syndrome or hypervitaminosis D.
Phosphate, 24-Hour Urine Preferred Specimen(s)
Transport Container
Instruction
719
10 mL of well mixed 24-hour urine
Plastic leak proof container
Please submit a 10 mL aliquot of a 24-hour collection. Refrigerate during and after collection. Collect urine with 25 mL of 6N HCl to maintain a pH below 3. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first
morning specimen voided the following morning at the same time as the previous morning’s first voiding. Record 24-hour urine volume on test request form and urine vial.
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Transport Temperature
Refrigerated 7 days
Reject Criteria
Received at room temperature
MethodologySpectrophotometry
Clinical Significance
Phosphorus is present in many foods with a mean intake of approximately 1.5 gm/day in adult men and 1.0 gm/day in adult women. Absorbed phosphate, under the influence of parathyroid hormone, is readily excreted by the kidney. Urinary phosphate measurement
generally reflects dietary intake hence day-to-day excretion varies considerably.
Phospholipid Antibodies Panel Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79050
IgG, IgM, IgA
1 mL serum
Plastic screw-cap vial
Refrigerated 3 days, -20oC Long term
Gross hemolysis • Plasma
ELISA
See in individual tests for Clinical Significance
Phospholipid Antibody IgA 79049
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stable 3 days, -20oC Long term
Reject Criteria
Gross hemolysis • Plasma
MethodologyELISA
Clinical Significance
Phospholipid autoantibodies specific to phosphatidylinositol(PI), phosphatidylglycerol(PG),
phosphatidylserine(PS), phosphatidylethanolamine(PE), phosphatidylcholine(PC), phosphatidic acid(PA), cardiolipin(CL) and sphingomyelin are found in hematolgic autoimmune diseases, especially antiphospholipid syndrome(APS) and systemic lupus
erythematosus(SLE). APS is characterized by arterial and venous thrombosis, thrombocytopenia, and recurrent fetal loss; thrombosis, thrombocytopenia and hemolytic anemia also occur in SLE and are associated with the presence of phospholipid autoantibodies. Women with infertility showing spontaneous abortion or in vitro fertilization failure demonstrate PI autoantibodies in 25% of cases.
Phospholipid Antibody IgG O
P
79047
Preferred Specimen(s)
1.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days, -20oC Long term
Reject Criteria
Gross hemolysis • Plasma
MethodologyELISA
Clinical Significance
Phospholipid autoantibodies specific to phosphatidylinositol(PI), phosphatidylglycerol(PG),
phosphatidylserine(PS), phosphatidylethanolamine(PE), phosphatidylcholine(PC), phosphatidic acid(PA), cardiolipin(CL) and sphingomyelin are found in hematolgic autoimmune diseases, especially antiphospholipid syndrome(APS) and systemic lupus
erythematosus(SLE). APS is characterized by arterial and venous thrombosis, thrombocytopenia, and recurrent fetal loss; thrombosis, thrombocytopenia and hemolytic anemia also occur in SLE and are associated with the presence of phospholipid autoantibodies. Women with infertility showing spontaneous abortion or in vitro fertilization failure demonstrate PI autoantibodies in 25% of cases.
Phospholipid Antibody IgM 79048
Preferred Specimen(s)
1.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days, -20oC Long term
Reject Criteria
Gross hemolysis • Plasma
MethodologyELISA
Clinical Significance
Phospholipid autoantibodies specific to phosphatidylinositol(PI), phosphatidylglycerol(PG),
phosphatidylserine(PS), phosphatidylethanolamine(PE), phosphatidylcholine(PC),
186
phosphatidic acid(PA), cardiolipin(CL) and sphingomyelin are found in hematolgic autoimmune diseases, especially antiphospholipid syndrome(APS) and systemic lupus
erythematosus(SLE). APS is characterized by arterial and venous thrombosis, thrombocytopenia, and recurrent fetal loss; thrombosis, thrombocytopenia and hemolytic anemia also occur in SLE and are associated with the presence of phospholipid autoantibodies. Women with infertility showing spontaneous abortion or in vitro fertilization failure demonstrate PI autoantibodies in 25% of cases.
Phosphorus
See “Phosphate”
Phosphorus, Random Urine 14579
Preferred Specimen(s)
2.0 mL hour urine
Transport Container
Plastic leak proof container
Transport Temperature
Refrigerated, stable 1 week
Reject Criteria
Received at room temperature
MethodologySpectrophotometry
Clinical Significance
Phosphorus is present in many foods witha mean intake of approximately 1500 mg per day for adult males and about 1000 mg per day for adult females. Absorbed phosphate, under the influence of parathyroid hormone is readily excreted in the kidney. Measurement of urinary phosphorus generally reflects dietary intake hence day to day excretion may show
considerable variation.
Plasminogen Activator Inhibitor (PAI-1) 36555
Preferred Specimen(s)
1 mL plasma collected in a 3.2% sodium citrate (light blue-top) tube
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed
MethodologyImmunoassay
Clinical Significance
Increased activity is associated with increased risk of arterial thrombosis, such as with unexplained premature myocardial infarction. As an acute phase reactant, the activity is increased after an acute event. Studies suggest PAI-1 may be a prognostic marker in early
stage breast cancer.
See Breast Cancer in the Hematology/Oncology section of Test Application and Interpretation.
Platelet Count EDTA Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
723
3 ml whole blood collected lavender top EDTA tube
Do not refrigerate
Sodium citrate (light blue-top) tube
Room temperature, stable 48 hours
Gross hemolysis • Clotted
Cell counting and Microscopy
Used to evaluate patient’s suspected of EDTA mediated platelet clumping. Platelets must be present in adequate numbers and have proper function to aid in hemostasis.
PM-Scl
See “Antibody to PM-Scl”
Polycystic Ovarian Syndrome Panel Includes
Preferred Specimen(s)
Transport Container
Instruction
78544
FSH, LH, Androstenedione, Testosterone, Fasting Insulin, Glucose, Fasting, , Insulin/Glucose Ratio– day 2 to day 5 of cycle
4 mL serum in no additive (red-top) tubes Insulin: 1 ml serum per specimen
Plastic screw-cap vial
Insulin tests: Overnight fasting is required. Draw fasting specimen. Administer oral glucose 187
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Transport Temperature
Reject Criteria
Methodology
Clinical Significance
solution (1.75 g/kg body weight or 75 g maximum). Collect 1 mL serum for each timed specimen post glucose dose. All tubes must be clearly marked with time drawn.
Submit all tubes with one test requisition.
Room temperature
Gross hemolysis • Hyperlipemia
Chemiluminescence, Immunoassay
See Individual test
Potassium, Serum Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
733
1 mL serum
See Phlebotomy (for serum) in the Blood, Urine and Stool section in Specimen Collection and Handling
Separate from cells as soon as possible after clotting
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Gross hemolysis • Plasma
Ion Selective Electrode (ISE)
Potassium measurements are useful in monitoring electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Potassium is elevated in adrenal cortical insufficiency, acute renal failure and in some
cases of diabetic acidosis. Potassium is decreased in diuretic administration and renal tubular acidosis.
Potassium, Random Urine 14521
Preferred Specimen(s)
2.0 mL Urine
Transport Container
Plastic Screw cap vial
Transport Temperature
Ambient 7 days, Refrigerated, stable 7 day’s
MethodologySpectrophotometry
Clinical Significance
Urinary excretion of potassium is increased in primary aldosteronism. It is often increased in dehydration and in salicylate toxicity. Decreased levels are seen in malabsorption.
PRA
See “Renin Activity, Plasma”
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Prealbumin 4847
Preferred Specimen(s)
1 mL serum
Transport Container
1 (red-top) tube
Transport Temperature
Refrigerated, stable 7 day’s
Reject Criteria
Gross hemolysis • Hyperlipemic
Methodology
Nephelometry
Clinical Significance
Prealbumin is decreased in protein-calorie malnutrition, liver disease, and acute inflammation. It may be used as an indicator of nutritional requirements and response to therapy during total parenteral nutrition and as a biochemical marker of nutritional adequacy in premature
infants.
Prenatal Panel
See “Obstetric Panel”
Pregnancy Associated Plasma Protein - A (PAPP-A) 79971
Preferred Specimen(s)
1 mL Serum
Transport Container
Plastic screw cap vial
Transport TemperatureFrozen
Reject CriteriaHemolyzed
Methodology
Chemiluminescence Assay
Clinical Significance
Maternal serum PAPP-A assessment between 11 and 14 weeks of pregnancy is reported to 188
have significant utility in screening & Down syndrome and other chromosomal abnormalities. A combination of maternal age related risk, Free â-HCG & fetal nuchal translucency (NT) measurements might substantially increase the efficiency of prenatal screening compared to second trimester screening; using this approach, various investigators have reported detection rate for Down syndrome of 85 to 90 percent at a five percent false positive rate.
proBNP, N-terminal 11188
Preferred Specimen(s)
1 mL plasma
Instructions
Collect in EDTA (lavender-top) tube. Separate plasma as soon after collection as possible. Keep refrigerated or frozen after separation.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stable 3 day’s, Frozen 6 months
Reject Criteria
Received room temperature
MethodologyElectrochemiluminescence
Clinical Significance
BNP is used to aid in the diagnosis of left ventricular dysfunction in heart failure. In contrast with BNP, Nterminal pro-BNP does not have interference with the drug Natrecor® used to treat left ventricular dysfunction. See Non-Lipid Markers in Cardiovascular Disease (CVD)
in the Cardiovascular section of Test Application and Interpretation.
Progesterone, LC/MS/MS 17183
Preferred Specimen(s)
1 mL serum collected in a (red-top) tube (no gel)
Instructions
Separate serum after clotting. Ship serum refrigerated or frozen. Do not submit glass tubes. An early morning specimen is preferred. Specify age, sex and menopausal status on the test requisition.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Serum separator tubes (SST®s) • Glass tubes
Methodology
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Clinical Significance
This test (1) establishes the presence of a functioning corpus lutem or luteal cell function, (2) confirms basal body temperature measurements of the occurrence of ovulation, (3) affords an indication of the day of ovulation, (4) assesses placental function during pregnancy.
Progesterone Serum 745
Preferred Specimen(s)
3 mL serum
Instructions
It is recommended that the serum is removed from the red cells or barrier gel and the serum submitted in a plastic serum transport container. Prolonged contact of the serum with the barrier gel can cause decreased progesterone results.
Transport Container
Plastic screw-cap vial or barrier.
Barrier gel is acceptable if tested within 24 hours
Transport Temperature
Refrigerated, stable 48 hours
MethodologyChemiluminescence
Rejection Criteria
Plasma; Hemolyzed specimens
Prolactin 746
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient, stable 7 day’s, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Grossly icteric • Grossly lipemic
MethodologyChemiluminescence
Clinical Significance
Prolactin is a single-chain polypeptide hormone secreted by the anterior pituitary under the control of prolactinreleasing factors. These inhibiting and releasing factors are secreted by the hypothalamus. Prolactin is also synthesized by the placenta and is present in amniotic
fluid. Prolactin initiates and maintains lactation in females. It also plays a role in regulating gonadal function in both males and females. In adults, basal circulating prolactin is present in concentrations up to 30 ng/mL. During pregnancy and postpartum lactation, serum 189
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prolactin can increase 10- to 20-fold. Exercise, stress, and sleep also cause transient increases in prolactin levels. Consistently elevated serum prolactin levels greater than 30 ng/mL, in the absence of pregnancy and postpartum lactation, are indicative of hyperprolactinemia, which is the most common hypothalamic-pituitary dysfunction encountered in clinical endocrinology. Hyperprolactinemia often results in galactorrhea, amenorrhea, and infertility in females, and in impotence and hypogonadism in males. Renal failure, hypothyroidism, and prolactin-secreting pituitary adenomas are also common causes of abnormally elevated prolactin levels.
See Polycystic Ovary Syndrome (PCOS) in the Endocrinology section of Test Application and Interpretation.
Propoxyphene, Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78089
5.0 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Phencyclidine (PCP), Urine Preferred Specimen(s)
Instruction
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
O
P
78088
10 mL Urine
Collect urine sample without preservative
Plastic, leakproof container
Ambient 7 days, Refrigerated 14 days
Sample coating preservative
Enzyme Immunoassay
The presence of drug may be indicative of therapeutic use or of substance abuse, depending on the drug. The time period for which drug can be detected is variable and dependent on a large variety of factors. Some of these factors include: (1) Amount of drug ingested; (2) individual metabolism; (3) dilution of the urine by water.
Protein C Activity 1777
Preferred Specimen(s)
1 mL platelet-poor plasma collected in a sodium citrate (light blue-top) tube
Instructions
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed
Methodology
Clotting Assay
Clinical Significance
Aids in diagnosis of decreased activity of Protein C characterized by recurrent venous thrombosis. Acquired deficiencies associated with Protein C include: oral anticoagulant therapy, liver disease, vitamin K deficiency, malignancy, consumptive DIC, surgery, trauma, antibodies to Protein C and hepatic immaturity of the newborn.
Protein C Activity and Antigen Preferred Specimen(s)
Instructions
190
8757
1 mL plasma in two separate tubes collected in a 3.2% Sodium Citrate (light blue-top) tube
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed • Hemolyzed samples • Received room temperature • Received refrigerated
Methodology
Chromogenic Substrate • Enzyme immunoassay
Clinical Significance
Comprehensive test assesses the total level of protein and its functional activity in determining Protein C deficiency, which is strongly prothrombotic, and may require long-term anticoagulation therapy. In the presence of low Protein C Activity, Protein C Antigen helps to confirm and to classify Protein C Deficiency as Type I or Type II. Protein C is a highly thrombophilic protein.
Protein C Antigen 4948
Preferred Specimen(s)
Platelet-poor 3.2% citrate anticoagulated plasma collected in (light blue-top) tube
Instructions
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place
into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Received refrigerated • Received thawed
Methodology
Enzyme immunoassay
Clinical Significance
Aids in diagnosis of congenital deficiencies characterized by recurrent venous thrombosis. Acquired deficiencies associated with Protein C include: oral anticoagulant therapy, liver disease, vitamin K deficiency, malignancy, consumptive DIC, surgery, trauma, antibodies
to Protein C and hepatic immaturity of the newborn.
Protein Electrophoresis, Serum (SPEP) 747
Includes
Total Protein, Protein Electrophoresis
Preferred Specimen(s)
5 mL serum
Transport Container
Plastic screw-cap vial
Transport TemperatureRefrigerated
Methodology
Capillary Electrophoresis
Clinical Significance
Protein Electrophoresis evaluates the major protein fractions (i.e., albumin, alpha 1, alpha 2, beta and gamma proteins) to determine if there are deficiencies or excesses, as seen with macroglobulinemia, monoclonal gammopathy of undetermined significance (MGUS), and multiple myeloma.
Protein S Activity 1779
Preferred Specimen(s)
1 mL platelet poor plasma 3.2% sodium citrate in (light blue-top) tube
Instructions
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received thawed
Methodology
Clot Detection
Clinical Significance
The congenital or acquired deficiency of Protein S increases the risk for thromboembolism, 191
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owing to a decrease of blood anticoagulant potential. It results in recurring thrombotic episodes. A decrease of Protein S leads to a greater risk of thromboembolism.
Protein S Antigen 5165
Preferred Specimen(s)
Platelet poor 3.2% sodium citrate-anticoagulated plasma collected in (light blue-top) tube
Instructions
Draw blood in (light blue-top) tube containing 3.2% sodium citrate, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place
into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received thawed
Methodology
Latex Agglutination
Clinical Significance
The congenital or acquired deficiency of protein S increases the risk for thromboembolism, owing to a decrease of blood anticoagulant potential. It results in recurring thrombotic episodes. A decrease of protein S leads to a greater risk of thromboembolism.
Protein, Total Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
754
1 mL serum
Plastic screw-cap vial
Refrigerated 14 days
Gross hemolysis • Plasma
Spectrophotometry (SP)
The total serum protein level is the sum of all circulating proteins that are major components of blood. Serum total protein measurements are useful in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic
or nutritional disorders.
Protein, Total, CSF O
P
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
755
1.0 mL CSF
Plastic screw-cap container
Refrigerated 72 hrs
Hemolysed specimen
Spectrophotometry, Colorimetric
CSF Total Protein is derived from ultrafiltration of plasma through the meninges and choroid plexus and intrathecal production. CSF Total Protein is useful in identifying increased permeability of the blood-brain barrier or increased intrathecal production. Elevated CSF Total Protein is often consistent with central nervous system disease or trauma.
Protein, Total, 24-Hour Urine with Creatinine 757
Preferred Specimen(s)
10 ml aliquot from a well-mixed, 24-hour collection
Instructions
No preservatives. Record volume on test request form and aliquot bottle.
Note: The urinalysis transport tube (yellow-top, blue fill line, preservative tube) cannot be used for protein electrophoresis on urine. Please submit 25 mL aliquot of 24 hour urine (no preservatives).
Transport Container
Plastic screw-cap container
Transport Temperature
Refrigerated 7 days
Reject Criteria
Acidified urine
Methodology
Spectrophotometry, Colorimetric
Clinical Significance
Proteinuria, mainly glomerular, is often a manifestation of primary renal disease although transient proteinuria may occur with fevers, thyroid disorders, and in heart disease. In the absence of renal disease, the degree of proteinuria is slight, usually amounting to less than 2 grams per day. In chronic glomerulonephritis and in the nephrotic syndrome including lipoid nephrosis and in some forms of hypertensive vascular disease, protein loss may vary 192
from a few grams to as much as 30 g/day.
See “Chronic Kidney Disease” in the Test Application and Interpretation.
Protein, Total, Random Urine with Creatinine 1715
Preferred Specimen(s)
10 ml urine from a well mixed random collection. No preservative.
Note: The urinalysis transport tube (yellow-top, blue fill line, preservative tube) cannot be used for protein electrophoresis on urine. Please submit random urine with no preservative.
Transport Container
Plastic screw-cap urine container
Transport Temperature
Refrigerated 48 hrs
Reject Criteria
Acid-preserved urine
MethodologySpectrophotometry
Clinical Significance
Proteinuria is characteristic of renal disease and concentrations may be increased with diabetes, hypertension, nephritic syndrome, and drug nephrotoxicity
Prothrombin (Factor II) 20210G. A Mutation Analysis Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
17909
5 mL whole blood
EDTA (lavender-top)
Room temperature
Received frozen
Polymerase Chain Reaction, Oligonucleotide Ligation Assay, Fluorescent Microspheres
Factor II Mutation (G20210A) is one of the most common causes of venous thrombosis. 2.3% of the general population is heterozygous in contrast with 6.2% of patients with venous thrombosis and 18% with familial venous thrombosis. Other risk factors compound
the risk for venous thrombosis.
Prothrombin Time with INR 8847
Preferred Specimen(s)
One full 3.2% sodium citrate (light blue-top) tube
Instructions
A completely filled tube is necessary because the correct ratio of blood to citrate is critical (9:1). Mix by gentle inversion 3-4 times. Do not uncap. Stable 2 days at room temperature. If the specimen will be delayed longer than 2 days, centrifuge specimen for 15 minutes at 1500 RCF (relative centrifugal force). Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic screw-cap vial and freeze at -
20o C. Ship on dry ice.
Transport Container
Whole blood: 3.2% sodium citrate (light blue-top) tube
Plasma: Plastic screw-cap vial (frozen)
Transport Temperature
Room temperature: (Light blue-top) tube (whole blood)
Frozen: Plasma
Reject Criteria
Gross hemolysis • Improper blood to citrate ratio • High hematocrit • Improper blood collection
Methodology
Clotting Method
Clinical Significance
Screening test for abnormalities of coagulation factors that are involved in the extrinsic pathway. Also used to monitor effects of Coumadin® anticoagulants and to study patients with hereditary and acquired clotting disorders.
PSA Total 5363
Preferred Specimen(s)
1 mL serum
Instructions
Non-frozen specimens must be received in the laboratory within 24 hours
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 24 hrs, Refrigerated 24 hrs
MethodologyChemiluminescence
Clinical Significance
Elevated serum PSA concentrations have been reported in men with prostate cancer, benign prostatic hypertrophy, and inflammatory conditions of the prostate. See Prostate Cancer in the Hematology/Oncology section of Test Application and Interpretation.
PSA, Free and Total 31348
193
O
P
Includes
Total PSA, Free PSA, % Free PSA (calculated)
Preferred Specimen(s)
2 mL serum
Instructions
Non-frozen specimens must be received in the laboratory within 24 hours
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 24 hrs, Refrigerated 24 hrs
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
In men over age 50 years with total PSA between 4.0 and 10.0 ng/mL, those with prostate cancer tend to have lower % free PSA than those with benign prostatic hypertrophy (BPH), although there is considerable overlap in results for the two populations. % free PSA may aid in avoiding unnecessary biopsies in these circumstances.
See Prostate Cancer in the Hematology/Oncology section of Test Application and Interpretation.
PT
See “Prothrombin Time with INR”
PTT
See “Partial Thromboplastin Time, Activated (aPTT)”
PTH, Intact and Calcium 8837
Preferred Specimen(s)
2 mL frozen serum collected in a (red-top) tube (no gel)
Instructions
Spin and transfer to a plastic transport vial. Mark the specimen type as serum on the vial. Freeze and submit to the laboratory. Do not submit glass tubes.
Note: Sodium or lithium heparin are no longer acceptable specimen types.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Plasma • Received room temperature • Received refrigerated • Gross Hemolysis • Lipemia
Methodology
Immunochemiluminometric Assay (ICMA)
Clinical Significance
The major function of PTH is to maintain the serum total calcium concentration within a narrow range. The net effects of PTH are to increase the serum concentration of calcium and to decrease that of phosphate. The assay is useful in making the diagnosis of primary
hyperparathyroidism, secondary hyperparathyroidism, and a differential diagnosis of hypercalcemia. The assay helps in distinguishing hypercalcemia caused by either primary hyperparathyroidism or malignant disease.
See Calcium and Bone Metabolism (Including Osteoporosis) in the Endocrinology section of Test Application and Interpretation.
Q
R
PTH-Related Protein (PTH-rP) 34478
Preferred Specimen(s)
1.5 mL plasma collected in a PTH-related protein (special collection) tube
Instructions
Store cocktail tube in the freezer at -20°C (tubes can be stored for up to one year). The cocktail tube is a heparin tube with protease inhibitor (aprotinin, leupeptin & blue dye) added (glass or plastics collection tubes are acceptable). Prior to drawing samples, place PTHrP cocktail tubes on ice. Collect the whole blood into a syringe and transfer the sample into the cocktail tube. Alternatively, if a syringe is not available, collect the blood in a plain red-top tube and immediately transfer the sample into the cold cocktail tube. Mix thoroughly by inversion. Immediately separate the plasma from the cells in a refrigerated centrifuge and transfer to a plastic test tube. Freeze immediately at -20°C or colder. If a refrigerated centrifuge is not available, chill the tubes and the centrifuge tube holders for 5 minutes in an ice lurry. Ship frozen.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Received refrigerated
MethodologyImmunoassay
Clinical Significance
Parathyroid hormone-related peptide (PTH-rP) is structurally and functionally similar to human parathyroid hormone (HPTH). Hypercalcemia of malignancy is due either to local 194
osteolysis at the site of bone metastases or to PTH-rP production by the malignant cells.
Pyrexia of Unknown Origin (PUO) Panel Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78657
CBC with peripheral blood smear; ESR; Urinalysis Complete; Malaria Blood Parasite; Widal Test; Culture Blood; Alanine Amino Transferase (ALT/SGPT)
6.0 mL whole blood collected in EDTA tube (leavender top), 2.0 mL serum, 5.0 mL urine collected with preservative
Serum - Plastic screw-cap vial, Whole blood – Collection tube, Urine – Leak proof container
Room Temperature
Plasma • Gross Hemolysis • Lipemia
See individual analytes
See individual tests for clinical significance.
Quantiferon GoldTB 19453
Preferred Specimen(s)
1 ml whole blood in each grey, red top and purple top TB Gold tubes. ( Use the tube sent by Quest Diagnostics only)
Transport Container
3 TB Gold tubes (grey, red top & purple top)
Instructions
-> Store & ship the tubes at room temperature if the tubes can reach the Quest Diagnostics (QDI) Lab at Gurgaon maximum within 16 hrs of collection of sample
-> If the sample can not reach the QDI lab at Gurgaon within 16 hrs of collection then incubate the red top, grey top & the purple top tubes in calibrated incubator at 37°C ± 1°C for 16-24 hrs. This incubation is mandatory within 16 hrs of collection of the sample.
After incubation for 16-24 hrs at 37°C ± 1°C in a calibrated incubator, the sample can be sent in the following ways:
(i) If the incubated sample can reach the QDI lab at Gurgaon within 72 hrs after incubation then the red top, grey top & purple top should be ship at 2-8 °C
(ii) If the incubated sample is likely to reach QDI lab after 72 hrs of incubation the primary tubes (red top, grey top & purple top) has to be centrifuged at 2000-3000 RCF(g). Separate the plasma in a screw capped plastic vial after centrifugation & ship frozen. Separate the plasma (from grey top, Red to & purple top vial) in three different screw capped transportation plastic vials after centrifugation & ship frozen.
(iii) Label the vials with source of plasma for e.g. as grey top, red top & purple top.
Transport Temperature
If transported within 16 hours of collections: 22°C + 5°C
If tubes incubated : 2 - 27°C for 3 days
Separated Plasma : 2 - 8°C for 4 weeks & -20°C for extended period
MethodologyELISA
Clinical Significance
The Quantiferon TB Gold test is helpful but insufficient in diagnosing M. tuberculosis complex infection in sick patients: a positive result can support the diagnosis of tuberculosis disease. However, infections by other mycobacteria (e.g., M. kansasii) could also cause a positive results. Other medical and diagnostic evaluations are necessary to confirm or exclude tuberculosis disease.
Renal Function Panel 1 Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Creatinine with eGFR; BUN; BUN/Creatinine Ratio; Uric Acid
2.0 mL serum and 5.0 mL urine collected with preservative
Serum - Plastic screw-cap vial, Urine – Leak proof container
Ambient 5 days, Refrigerated 14 days
Plasma • Gross Hemolysis • Lipemia
See individual analytes
See individual tests for clinical significance.
Renal Function Panel 2 Includes
Preferred Specimen(s)
Transport Container
78591
78592
Creatinine with eGFR; BUN; BUN/Creatinine Ratio; Uric Acid; Na; K; Cl; Anion Gap
2.0 mL serum and 5.0 mL urine collected with preservative
Serum - Plastic screw-cap vial, Urine – Leak proof container
195
Q
R
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Ambient 5 days, Refrigerated 14 days
Plasma • Gross Hemolysis • Lipemia
See individual analytes
See individual tests for clinical significance
Reticulin Stain With Interpretation Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Tissue biopsy in 10% buffered formalin or formalin fixed paraffin embedded tissue block.
Paraffin block bag; slide holder (as applicable)
Room temperature
Improper fixation; Receive Frozen
Manual staining
Reticular fibers are present in normal human tissues and have a support function.They are normally found throughout the body but are most abundant in liver, spleen, kidney and lymph nodes.In certain tumors, reticulin is located in a characteristic position in relation
to the actual tumor cells. Reticulin stains can therefore be an important diagnostic tool for the differential diagnosis of certain types of tumor.
Reticulin Stain Without Interpretation Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78122
78889
Tissue biopsy in 10% buffered formalin or formalin fixed paraffin embedded tissue block.
Paraffin block bag; slide holder (as applicable)
Room temperature
Improper fixation; Received Frozen
Manual staining
Reticular fibers are present in normal human tissues and have a support function.They are normally found throughout the body but are most abundant in liver, spleen, kidney and lymph nodes.In certain tumors, reticulin is located in a characteristic position in relation to the actual tumor cells. Reticulin stains can therefore be an important diagnostic tool for the differential diagnosis of certain types of tumor.
Reticulocyte Count, Automated 793
Preferred Specimen(s)
Whole blood full EDTA (lavender-top) tube - mix well by gentle inversion
Instructions
Maintain specimen at room temperature. If multiple draw, collect (lavender-top) tube last.
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Room temperature
Reject CriteriaClotted
Methodology
Electronic Cell Sizing and Counting/Cytometry/Microscopy
Clinical Significance
Use in evaluating erythropoietic activity RF
See “Rheumatoid Factor”
Rheumatoid Factor S
T
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Rotavirus Antigen Preferred Specimen(s)
Transport Container
Transport Temperature
196
4418
1 mL serum
Plastic screw-cap vial
Room temperature 1 week, Refrigerated 14 days
Gross hemolysis • Lipemia
Nephlometry
Elevated RF is found in collagen vascular diseases such as SLE, rheumatoid arthritis, scleroderma, Sjögren’s Syndrome, and in other conditions such as leprosy, tuberculosis, syphilis, malignancy, thyroid disease and in a significant percentage of otherwise normal elderly patients
79051
Stool specimen or rectal swab in a clean, dry container without preservatives or media
See Stool in the Bacteria section of Specimen Collection and Handling for instructions.
Plastic screw-cap vial
Refrigerated (cold packs)
Reject Criteria
Transport systems containing media, serum, preservatives or detergent
MethodologyELISA
Clinical Significance
Rotavirus infection is the major cause of gastroenteritis in children from six months to two years. Infection occurs in both sporadic and epidemic forms and is responsible for approximately half the cases of diarrhea in infants that require hospitalization worldwide. The peak of rotavirus disease in temperate climates occurs during the cooler months of the year. Rotavirus has also emerged as a cause of enteritis in adults, particularly in elderly immunosuppressed patients.
RPR for Syphilis 799
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, Stability 7 days
Reject Criteria
Gross hemolysis • Hyperlipemia • CSF
MethodologyFloculation
Clinical Significance
This is a non-treponemal screening test for syphilis. False positive results may occur due to systemic lupus erythematosus, malaria, mononucleosis, infectious hepatitis, leprosy, brucellosis, atypical pneumonia, typhus, yaws, pinta, or pregnancy. Positive results should be confirmed with a more specific treponema pallidum antibody test (FTA-ABS). Monitoring of RPR is helpful in assessing effectiveness of therapy.
Rubella Antibodies (IgG, IgM) 79534
Includes
Rubella IgG, Rubella IgM
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stability 3 days
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyCLIA
Clinical Significance
Rubella is an acute exanthematous viral infection of children and adults. Rash, fever and lymphadenopathy characterize the illness. While many infections are subclinical, this virus has the potential to cause fetal infection with resultant birth defects. Diagnosis of a Rubella infection is best made serologically. In the absence of a current or recent infection, a demonstration of specific IgG on a serum sample is evident of immunity to Rubella.
Rubella Antibodies, IgG 79916
Preferred Specimen(s)
1 mL serum
Instructions
Allow specimen to clot at room temperature and then centrifuge. Immediately separate from cells and refrigerate at 2-8°C.
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated, stability 3 days
Reject Criteria
Received frozen
MethodologyCLIA
Clinical Significance
Rubella is an acute exanthematous viral infection of children and adults. Rash, fever and lymphadenopathy characterize the illness. While many infections are subclinical, this virus has the potential to cause fetal infection with resultant birth defects. Diagnosis of a rubella infection is best made serologically. In the absence of a current or recent infection, a demonstration of specific IgG on a serum sample is evidence of immunity to rubella.
Rubella Antibodies (IgM) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
79915
1 mL serum
Allow specimen to clot at room temperature and then centrifuge. Immediately separate from cells and refrigerate at 2-8°C.
No additive (red-top) tube
Refrigerated, stability 3 days
197
S
T
Reject Criteria
Received frozen
MethodologyCLIA
Clinical Significance
Testing immediately post-exposure is of no value without a later convalescent specimen. While the presence of IgM antibodies suggests current or recent infection, low levels of IgM antibodies may occasionally persist for more than 12 months post-infection or immunization.
Saccharomyces (ASCA) IgA 79061
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic Screw cap vial
Transport Temperature
Refrigerated, stable 48 hours
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Antibodies to Saccharormyces cerevisiae are found in approximately 75% of patients with Crohn’s disease, 15% of patients with ulcerative colitis, and 5% of the healthy population. High titers of antibody increase the likelihood of disease, and specifically Crohn’s disease,
and are associated with more aggressive disease.
Saccharomyces (ASCA) IgG 79062
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic Screw cap vial
Transport Temperature
Refrigerated, stable 48 hours
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Antibodies to Saccharormyces cerevisiae are found in approximately 75% of patients with Crohn’s disease, 15% of patients with ulcerative colitis, and 5% of the healthy population. High titers of antibody increase the likelihood of disease, and specifically Crohn’s disease,
and are associated with more aggressive disease.
Salmonella, Shigella, Campylobacter Stool Culture
See “Culture, Stool (Salmonella/Shigella/ Campylobacter)”
Screening Fever Panel Includes
Test Components
Scl-70 S
T
78583
CBC, ESR, Malarial Parasite & Urinalysis
79930 - ESR
5463 - Urinalysis
6399 - CBC
831 - Malaria/Blood parasite
See individual test for details
79085
Preferred Specimen(s)
1.0 mL Serum
Transport Container
Plastic Screw cap vial
Transport Temperature
Refrigerated 3 days, -20oC Long term
Reject Criteria
Grossly Hemolysed
MethodologyELISA
Clinical Significance
Scleroderma may be localized or diffuse [Progressive Systemic Sclerosis (PSS)] that may involve skin, gastrointestinal tracts, lungs, vascular and cardiac systems, and kidneys. Scl-70 Antibody is present in approximately 40% of patients with PSS.
Serotonin, Serum 29851
Patient Preparation
Patient should avoid food high in indoles: Avocado, banana, tomato, plum, walnut, pineapple, and eggplant. Patient should also avoid tobacco, tea and coffee three days prior to specimen collection.
Preferred Specimen(s)
2 mL serum collected in a (red-top) tube (no gel)
Instructions
Spin and freeze serum below -20oC within 2 hours after collection
Transport TemperatureFrozen
198
Reject Criteria
Methodology
Received room temperature • Received refrigerated
High Performance Liquid Chromatography (HPLC) • Fluorescence Detection
Serum Immunofixation Electophoresis Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
79101
1.0 mL serum
Plastic screw-cap vial
Refrigerated, stable 10 day’s, Frozen 1 month
Capillary Electrophoresis
Monoclonal increases in IgG or IgA are often associated with diseases such as multiple myeloma, lymphomas or leukemia. A monoclonal increase in IgM is commonly associated with Waldenström’s macroglobulinemia.
Sex Hormone Binding Globulin (SHBG) 30740
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 7 days
Reject Criteria
Gross hemolysis • Plasma
MethodologyChemiluminescene
Clinical Significance
Testosterone, dihydrotestosterone and estrogens circulate in serum bound to Sex Hormone Binding Globulin (SHBG). SHBG concentrations are increased in pregnancy, hyperthyroidism, cirrhosis, oral estrogen administration and by certain drugs. Concentrations are decreased by testosterone, hypothyroidism, Cushings syndrome, acromegaly and obesity.
Sickle Cell Anemia Mutation Analysis Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
26382
Amniotic fluid: Collect 10-20 mL amniotic fluid in a sterile plastic container
Chorionic villus sample (CVS): Collect 15-30 mg of chorionic villi in a sterile container. Add 2-3 mL of sterile saline or tissue culture medium.
Cultured cells: Ship two 100% confluent T-25 flasks filled with growth media. Ship at room temperature. Do not refrigerate or freeze. Call lab for additional requirements for prenatal testing. Indicate source of cells: Amniotic Fluid (AF) or Chorionic Villus Sample (CVS).
Test code 10262 (Maternal Cell Contamination Study, STR Analysis) may be ordered with this test to rule out maternal contamination of the fetal sample
Sterile transport tube for amniotic fluid
Room temperature
Received frozen
Polymerase Chain Reaction (PCR), Restriction Fragment Length Polymorphism
This test is intended for the detection of hemoglobin S and C sickle cell trait prenatally. Parents should be tested for carrier status before or simultaneously with the prenatal testing.
Sjogren’s Antibody (SS-A) / (Anti-Ro) 38568
Preferred Specimen(s)
1.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stable 24 hours, -20oC Long term
Reject Criteria
Gross hemolysis • Hyperlipemic
MethodologyELISA
Clinical Significance
Sjögren’s syndrome is an autoimmune disease of unknown etiology occurring predominantly (over 90%) in women in the fourth to sixth decades of life. SSB antibodies have a high specificity for the sicca complex, which results from a failure of secretion by lacrimal, salivary and other glands. SSA antibodies may also be detected in cases of congenital heart block, neonatal lupus and in approximately 30% of SLE patients.
Sjogren’s Antibody (SS-B) / (Anti-La) Preferred Specimen(s)
Transport Container
Transport Temperature
38569
1.0 mL serum
Plastic screw-cap vial
Refrigerated, stable 24 hours, -20oC Long term
199
S
T
Reject Criteria
Gross hemolysis • Hyperlipemic
MethodologyELISA
Clinical Significance
Sjögren’s syndrome is an autoimmune disease of unknown etiology occurring predominantly (over 90%) in women in the fourth to sixth decades of life. SSB antibodies have a high specificity for the sicca complex, which results from a failure of secretion by lacrimal,
salivary and other glands. SSA antibodies may also be detected in cases of congenital heart block, neonatal lupus and in approximately 30% of SLE patients.
Slide Review (upto 2 slides/blocks)
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Block, H & E slides submitted in slide folder
This code is for a consultation (2nd opinion) on previously diagnosed material. Required information: Patient history and any other relevant information; name, telephone number and fax number of referring physician.
Send blocks in plastics containers & slides in slide folder (preferably)
Room temperature
Broken slides, Improperly stained slides
Microscopy
The nature of possible underlying disease states can often be detected by microscopically visualizing histologic changes in tissue biopsies
Slide Review (more than 2 slides/blocks)
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79520
Provide a copy of the surgical pathology report. Mention number of slides to be issued. If more than one slide issue required, charges will be that number of time.
SM/RNP antibodies S
T
79121
Block, H & E slides submitted in slide folder
This code is for a consultation (2nd opinion) on previously diagnosed material. Required information: Patient history and any other relevant information; name, telephone number and fax number of referring physician.
Send blocks in plastics containers & slides in slide folder (preferably)
Room temperature
Broken slides, Improperly stained slides
Microscopy
The nature of possible underlying disease states can often be detected by microscopically visualizing histologic changes in tissue biopsies
Slide for Issue (1 slide only)
Instructions
79120
79075
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 24 hrs, -20oC Long term
MethodologyELISA
Clinical Significance
Smith (Sm)/U1-RNP Antibody is detected in patients with mixed connective tissue disease (having features of systemic lupus erythematosus (SLE), scleroderma, and polymyositis).
Sodium Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
836
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Gross hemolysis • Anticoagulants other than heparin
Ion Selective Electrode (ISE)
Sodium measurements are useful in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s Disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance
Sodium, Random Urine 200
14522
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
2 mL urine
Collect without preservatives. Refrigerate during and after collection. Aliquot unpreserved specimen before adding acid.
Plastic, screw cap container
Ambient 7 days, Refrigerated, stable 7 day’s
Received at room temperature
Ion Selective Electrode (ISE)
A urine test to check sodium levels is done to:
• Check the water and electrolyte balance of the body.
• Find the cause of symptoms from low or high levels of sodium.
• Check the progress of diseases of the kidneys or adrenal glands. Decreased levels are seen in congestive heart failure, excessive sweating, diarrhea, pyloric obstruction, malabsorption, and primary aldosteronism. Increased levels may be due to increased salt intake, failure of the adrenal glands, diabetic acidosis, salt losing renal disease, and water deficient dehydration.
Somatomedin-C
See “IGF-I”
SPEP
See “Protein Electrophoresis, Serum (SPEP)”
Stool Ova and Parasites Includes
Patient Preparation
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
681
Ova and Parasite Concentrate Result, Trichrome Result
Interfering substances - bismuth, barium (wait 7-10 days), antimicrobial agents (wait 2 weeks), gallbladder dye (wait 3 weeks after procedure)
Stool in 10% Formalin and Polyvinyl Alcohol (PVA) transport vials
See Stool Samples for Ova and Parasties (O & P) in the Parasites section of Specimen Collection and Handling Urine collected between noon and 3 PM may be submitted unpre
served to examine for schistosoma.
Deliver urine specimens to the laboratory as soon as possible
10% formalin and polyvinyl alcohol (PVA) transport vials Urine may be submitted in a sterile screw-cap container
Stool: Room temperature 48 hrs in formlin
Urine: Refrigerated (cold packs)
Unpreserved specimens • Specimens containing barium • Stool preserved in medium other than 10% formalin, PVA, Sodium Acetate-Acetic Acid Formalin (SAF) or Merthiolate Iodine Formalin (MIF) • Stool in 10% formalin received frozen • Stool submitted in expired transport vial
Microscopic Examination,Trichrome Stain & Modified Acid Fast Stain
Diseases caused by human parasites remain on a worldwide basis among the principle causes of morbidity and mortality. Correct diagnosis of intestinal parasitic infection depends on proper collection, transport, detection and identification of parasites in stool specimens.
Symptoms range from malaise to death. Treatment is dependent upon examining multiple stool exams due to the erratic shed rates of some parasites.
Stool (Salmonella, Shigella, Campylobacter) Culture
See “Culture, Stool (Salmonella/Shigella/Campylobacter)”
Stool Blood
See “Fecal Globin by Immunochemistry (InSure®)”
Stool Routine/Microscopic Preferred Specimen(s)
Instructions
4497
10 gm fecal specimen in plastic, leak-proof container
Do not freeze
201
S
T
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Plastic, leak-proof feces container
Room Temperature, stable 48 hours
Received frozen
Microscopic Examination
Stool examination is useful to detect some gastrointestinal parasites and fungal elements. Other tests may be more appropriate to identify and culture bacterial infections.
Strep A
See “Anti-Streptolysin O Antibody (ASO)”
Streptococcus, Group A
See “Streptococcus, Group A, Culture”
See “Anti-Streptolysin O Antibody (ASO)”
Streptococcus, Group A, Culture 4485
Preferred Specimen(s)
Collect throat specimen using a red-cap, Amies liquid transport medium swab or swab in other liquid transport media
See Throat Cultures: Streptococcus, Group A in the Bacteria section of Specimen Collection and Handling.
Instructions
Indicate source of specimen on both the test request form and specimen transport device
Transport Container
Transport swab
Transport Temperature
Room temperature
Reject Criteria
Swabs >48 hours old • Expired transport device • Received frozen • Viral transport device • DNA probe transport device
Methodology
Conventional Culture,Microscopic & Automation
Clinical Significance
Recovery of group A Streptococcus from a symptomatic patient is usually considered significant
Syphilis
See “RPR (Monitor) with Reflex to Titer”
T3 Free (FT3) 34429
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient, stable 4 day’s, Refrigerated 14 days
MethodologyChemiluminescence
Clinical Significance
See Thyroid Disease in the Endocrinology section of Test Application and Interpretation.
T3 Total S
T
859
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient, stable 4 day’s, Refrigerated 14 days
MethodologyChemiluminescence
Clinical Significance
For diagnosis of T3 thyrotoxicosis
T4, Free (FT4) 866
Preferred Specimen(s)
1.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 14 days
MethodologyChemiluminescence
Clinical Significance
For diagnosis of hypothyroidism and hyperthyroidism
See Thyroid Disease in the Endocrinology section of Test Application and Interpretation
T4 Total (Thyroxine) 202
17733
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 7 days, Refrigerated 7 days
MethodologyChemiluminescence
Clinical Significance
Thyroxine (T4) is the major secretory hormone of the thyroid. Only 0.03% of T4 is unbound and free for exchange with tissues. Thyroid function may be assessed with thyroid stimulating hormone (TSH) and free T4 measured.
TA90 (Melanoma-Associated Antigen) 15524
Preferred Specimen(s)
1 mL serum
Instructions
Draw 5 mL blood in a red-top tube (no gel), allow blood to clot at room temperature for one hour and separate by centrifugation (1500 x g for 10 minutes)
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Hemolysis • Lipemia • Animal or post mortem specimen • Received room temperature
MethodologyELISA
Clinical Significance
This assay is indicated in the post-operative evaluation of all patients whose localized melanoma is curatively resected. Potentially 90% of 50,000 new cases each year.
See Melanoma in the Hematology/Oncology section of Test Application and Interpretation.
Testosterone, Free, Bioavailable and Total, LC/MS/MS 14966
Includes
Total Testosterone, Free and Bioavailable Testosterone (calculated), Sex Hormone Binding Globulin, Albumin
Preferred Specimen(s)
2.5 mL serum collected in a (red-top) tube (no gel)
Instructions
Specify age and sex on test requisition. Shipping frozen is acceptable.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Samples received in serum separator tubes (SST®s)
Methodology
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) • Calculation • Spectrophotometry • Immunochemiluminescent Assay
Clinical Significance
Helpful in assessing testicular function in males and managing hirsutism, virilization in females
See Polycystic Ovary Syndrome (PCOS) in the Endocrinology section of Test Application and Interpretation.
Testosterone, Total Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
873
2 mL serum collected in a (red-top) tube (no gel). Specify age and sex on test requisition.
Plastic screw-cap vial
Ambient 3 days, Refrigerated 14 days
Body fluids
Automated ICMA • Extraction • Chromatography •Chemiluminescence
Testosterone circulates almost entirely bound to transport proteins. Normally less than 1% is free. Testosterone measurements are used to assess erectile dysfunction, infertility, gynecomastia, osteoporosis, and hormone replacement therapy.
S
T
Throat Culture and Susceptibility
See “Culture, Throat”
Thrombophila Panel Includes
Preferred Specimen(s)
Transport Container
78590
Protein-C Functional, Protein-S Functional, APC-R, Antithrombin III, ANA ELISA, Anti DsDNA,
Factor V Leiden, Complement C3, Complement C4, Lupus Anti Coagulant (screening), Anti Cardiolipin – IgG & Anti Cardiolipin IgM
For Specimen requirements see individual Tests listed under Test Components.
Plastic screw cap vial
203
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
See individual tests for transport temperature
Hemolyzed, lipemic, leaked & QNS specimens
Chromogenic; Enzyme Immunoassay Invader Assay/Signal Amplification Clotting Assay
Fluorescence polarizaton Immunoassay Clot Detection
Decreased antithrombin III activity, protein C activity, free protein S, and the presence of a factor V (Leiden) and/or factor II 20210G>A mutation each contribute to an increased risk of hereditary thrombophilia. Approximately 10% of factor V (Leiden) heterozygotes also carry the prothrombin 20210G>A mutation. Likewise, protein C and/or S deficiency have been reported with factor V (Leiden) mutation. Since venous thrombosis is a multifactorial disorder, presence of a second risk factor further increases the thrombotic risk.
Thyroglobulin Antibodies (Atg) 267
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 7 days
Reject Criteria
Gross hemolysis • Hyperlipemic
MethodologyChemiluminescene
Clinical Significance
Measurement of thyroglobulin antibodies is useful in the diagnosis and management of a variety of thyroid disorders including Hashimoto’s thyroiditis, Graves Disease and certain types of goiter
Thyroglobulin Panel 30278
Includes
Thyroglobulin, Thyroglobulin Antibodies
Preferred Specimen(s)
2 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated, stable 7 day’s
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyChemiluminescene
Clinical Significance
Thyroglobulin (TG) is a secretory product only of the thyroid gland. The major clinical use of serum TG measurement is to monitor, but not to diagnose, patients with well-differentiated thyroid cancers. The measurement of thyroglobulin, after thyroidectomy and ablation of the thyroid gland, is useful to determine metastasis. Deficient TG synthesis is observed in
infants with goitrous hypo-thyroidism. Most patients with thyroid autoimmune disease have thyroglobulin antibody. The antiperoxidase antibody (anti-tpo) provides additional specificity. Approximately 95% of patients with diffuse goiter, hypothyroidism, or both have anti-tpo. Anti-tpo is especially useful with patients with subclinical hypothyroidism (elevated TSH and
normal free T4 concentrations). Many of these patients will develop hypothyroidism. With immunometric assays (sandwich assays), TGAB interference typically produces inappropriately low TG results, most likely caused by endogenous TG immune complexes that block one or more of the reagent antibodies from binding endogenous TG.
Thyroglobulin (Tg) S
T
15561
Preferred Specimen(s)
1.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated 3 days
Reject Criteria
Gross hemolysis • Hyperlipemic
MethodologyCLIA
Clinical Significance
Thyroglobulin (Tg) is a secretory product only of the thyroid gland. The major clinical use of serum Tg measurement is to monitor, but not to diagnose, patients with well-differentiated thyroid cancers. The measurement of thyroglobulin, after thyroidectomy and ablation of the thyroid gland, is useful to determine metastasis. Deficient Tg synthesis is observed in infants with goitrous hypothyroidism.
Thyroid Hormone Panel 2 Includes
Preferred Specimen(s)
204
T3 (Triiodothyronine), T4 (Thyroxine) and TSH (Thyroid Stimulating Hormone)
1 mL serum
4776
Transport Container
Sterile plastic screw-cap vial
Transport Temperature
Ambient 4 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyChemiluminescence
Clinical Significance
• The degree of suppression of TSH does not always reflect the severity of the hyperthyroidism. Therefore a measurement of free thyroid hormone levels is usually
required in patients with a suppressed TSH level. TSH level mild to modest decreases in patients with normal T4 and T3 levels indicates sub-clinical hyperthyroidism.
• Free T4 assays generally are considered to provide the more reliable indication of true thyroid status because only the free hormone is physiologically active. In developing hypothyroidism, T4 (Free T4) is the more sensitive indicator of developing disease and is therefore preferred for confirming hypothyroidism that has already been suggested by an elevated TSH result.
• The T3 is increased in almost all cases of hyperthyroidism and goes up before the T4 is elevated. Thus T3 levels are more sensitive indicator of hyperthyroidism than the total T4. T3 levels are therefore preferred for confirming hyperthyroidism that has already been
suggested by a suppressed TSH Levels.
• The Total T3 and T4 hormone concentration is dependent on the concentrations of thyroid binding proteins like Thyroid Binding Globulin (TBG), albumin and Thyroid Binding pre-
albumin (transthyretin). Thus, any conditions that affects the levels of thyroid binding
proteins will effect these hormone levels.
Thyroid Hormone Panel 3 35454
Includes
FT3, FT4, and TSH (Thyroid Stimulating Hormone)
Preferred Specimen(s)
1 mL serum
Transport Container
Sterile plastic screw-cap vial
Transport Temperature
Ambient 4 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyChemiluminescence
Clinical Significance
• The degree of suppression of TSH does not always reflect the severity of the hyperthyroidism. Therefore a measurement of free thyroid hormone levels is usually
required in patients with a suppressed TSH level. TSH level mild to modest decreases in patients with normal T4 and T3 levels indicates sub-clinical hyperthyroidism.
• Free T4 assays generally are considered to provide the more reliable indication of true thyroid status because only the free hormone is physiologically active. In developing hypothyroidism, T4 (Free T4) is the more sensitive indicator of developing disease and is therefore preferred for confirming hypothyroidism that has already been suggested by an
elevated TSH result. • The T3 is increased in almost all cases of hyperthyroidism and goes up before the T4 is
elevated. Thus T3 levels are more sensitive indicator of hyperthyroidism than the total T4. T3 levels are therefore preferred for confirming hyperthyroidism that has already been suggested by a suppressed TSH Levels.
• The Total T3 and T4 hormone concentration is dependent on the concentrations of thyroid binding proteins like Thyroid Binding Globulin (TBG), albumin and Thyroid Binding prealbumin (transthyretin). Thus, any conditions that affects the levels of thyroid binding
proteins will effect these hormone levels.
Thyroid Receptor Antibody
See “TSI (Thyroid Stimulating Immunoglobulin)”
Thyroid Stimulating Immunoglobulin
See “TSI (Thyroid Stimulating Immunoglobulin)”
Thyrotropin
See “TSH, Ultrasensitive“
Tissue Biopsy, Small 79016
205
S
T
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
*Endometrium *Cervical biopsy *Endoscopic biopsies *Trucut biopsies *Appendix *Conjunctival biopsy *Small diagnostic / incision biopsies, Tubal ligation/vas deferens
(Lumps less than one cm will be included in this category)
Send specimens only in 10% Neutral Buffered Formaldehyde (NBF) with formalin as health hazard label sign on container.
Screw cap and spill proof container
Room temperature
Autolysed tissue
Gross and Microscopic examination
Tissue Biopsy, Medium 79017
Preferred Specimen(s)
*Breast lump *Pilonidal sinus *Fistula/Sinus *Lymph Node *Ovarian Cyst *Eyeball (Non tumorous) *Gall bladder *Prostate (TURP) / Enucleation * Superficial lumps (more than one cm, less than 05 cm) *Brain & Spinal cord tumors *Small excision biopsies (lass than 5 cm) *Uterus with cervix without tubes/ovaries/Fibroids *Fibroids only *Products of conception, Liver biopsy (core), Renal biopsy(core), Skin biopsy, Bone biopsy (small)
(For bone biopsy, please send preoperative radiograph. For liver and kidney core biopsy, please provide necessary clinical and laboratory parameters.
For skin biopsy, preliminary clinical diagnosis/differential diagnosis should be provided with relevant clinical details. Uterus without tubes/ovary/fibroids will be included in this category.)
Instructions
Send specimens only in 10% Neutral Buffered Formaldehyde (NBF) with formalin as health hazard label sign on container.
Transport Container
Screw cap and spill proof container
Transport Temperature
Room temperature
Reject Criteria
Autolysed tissue
Methodology
Gross and Microscopic examination
Tissue Biopsy, Large
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
79038
*Uterus with cervix & tubes/ovaries/Fibroids *Ovarian tumors/Large cysts (more than 5 cm) *Eyeball (tumorous) *Non tumorous conditions of Thyroid gland/Testes/
Kidney - Nephrectomy for nontumor conditions. Intestinal resection(segmental) *Lymph Node (Block dissection) *Large bone biopsy(>5 cm)
(Please send preoperative radiographs for bone biopsy. Uterus with tubes/ovaries/fibroids are included in this category)
Send specimens only in 10% Neutral Buffered Formaldehyde (NBF) with formalin as health hazard label sign on container.
Screw cap and spill proof container
Room temperature
Autolysed tissue
Gross and Microscopic examination
Tissue Biopsy (Complex/Resection)
S
T
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
*Esophagectomy *Gastrectomy *Mastectomy *Hemi/Total colectomy *Large Bone Resection *Ovarian Tumor Resection. *Radical Nephrectomy for Cancer *Radical Neck Dissection *Radical Hysterectomy *Radical Orchidectomy *Soft Tissue Tumor Resections *Head & Neck Resection
(This category includes cancer resection specimens.)
Send specimens only in 10% Neutral Buffered Formaldehyde (NBF) with formalin as health hazard label sign on container.
Screw cap and spill proof container
Room temperature
Autolysed tissue
Gross and Microscopic examination
Tissue Transglutaminase (tTG) Antibody (IgG) 206
79040
11070
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
MethodologyELISA
Clinical Significance
Tissue Transglutaminase Antibody, IgG, test is useful in patients who are IgA-deficient. The IgG test also provides support for gluten-sensitive enteropathies beyond IgA the test.
Tissue Transglutaminase (tTG) Antibodies (IgG, IgA) 11073
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
MethodologyELISA
Clinical Significance
Tissue Transglutaminase Antibody, IgA, is useful in diagnosing gluten-sensitive enteropathies, such as Celiac Sprue Disease, and an associated skin condition, dermatitis herpetiformis. The IgG test is useful in patients who are IgA-deficient. The IgG test also provides support for gluten-sensitive enteropathies beyond IgA the test.
Tissue Transglutaminase (tTG) Antibody (IgA) 8821
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
MethodologyELISA
Clinical Significance
Tissue Transglutaminase Antibody, IgA, is useful in diagnosing gluten-sensitive enteropathies, such as Celiac Sprue Disease, and an associated skin condition, dermatitis herpetiformis.
ToRCH 10 IgG/IgM (Toxoplasma IgG & IgM, Rubella IgG & IgM, CMV IgG & IgM and HSV IgG & IgM)
Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
HSV 1 IgG, IgM; CMV IgG, IgM; Rubella IgG, IgM; Toxoplasma IgG, IgM
2.0 mL serum
Plastic screw-cap vial
Refrigerated 3 days (48 hrs for HSV1 IgG/IgM, 4 days HSV2 IgG/IgM)
Gross hemolysis • Hyperlipemic
CLIA (ELISA for HSV1 IgG/IgM & HSV2 IgG/IgM)
See individual tests for clinical significance
ToRCH 5 IgG (Toxoplasma IgG, Rubella IgG, CMV IgG, HSV1 IgG and HSV2 IgG) Includes
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79531
79530
HSV 1 & 2 IgG; CMV IgG; Rubella IgG; Toxoplasma IgG
2.0 mL serum
Plastic screw-cap vial
Refrigerated 3 days (48 hrs for HSV1 IgG/IgM, 4 days HSV2 IgG/IgM)
Gross hemolysis • Hyperlipemic
CLIA (ELISA for HSV1 IgG/IgM & HSV2 IgG/IgM)
See individual tests for clinical significance
S
T
ToRCH 5 IgM (Toxoplasma IgM, Rubella IgM, CMV IgM, HSV1 IgM and HSV2 IgM) 79529
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
2.0 mL serum
Plastic screw-cap vial
Refrigerated 3 days (48 hrs for HSV1 IgG/IgM, 4 days HSV2 IgG/IgM)
Gross hemolysis • Hyperlipemic
CLIA (ELISA for HSV1 IgG/IgM & HSV2 IgG/IgM)
See individual tests for clinical significance
Total Protein and Albumin Panel 7577
207
Includes
Total Protein; Albumin; Globulin; A/G Ratio
Preferred Specimen(s)
2.0 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated 14 days
Reject Criteria
Gross hemolysis • Hyperlipemic
MethodologySpectrophotometry
Clinical Significance
See individual test for Clinical Significance
Toxoplasma Antibody (IgG, IgM) 79532
Preferred Specimen(s)
1 mL serum
Instructions
Allow specimen to clot at room temperature and then centrifuge. Immediately separate from cells and refrigerate at 2-8°C. If not tested within 1 week, store frozen at -20°C. Avoid freezing and thawing.
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 14 days
Reject Criteria
Received at room temperature; Received frozen
MethodologyELISA
Clinical Significance
Toxoplasmosis is caused by infection by the parasite Toxoplasma gondii. Approximately 23% of the population carry the parasite but remain healthy while not immunocompromised. Transmission from a pregnant woman to her fetus can cause serious disease. A high Antibody IgG and Antibody IgM together support infection within the previously three months. A high Antibody IgG with a low-to-medium Antibody IgM together support infection within three to six months.
Toxoplasma Gondii Antibody (IgG) 79911
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic leak proof container
Transport Temperature
Refrigerated 3 days
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyCLIA
Clinical Significance
Toxoplasmosis is a parasitic infection caused by the protozoan Toxoplasma gondii. Approximately 23% of the immunocompetent population are asymptomatic carriers of the parasite. High titers of IgG antibodies to Toxoplasma gondii can persist for years. Rising IgG titers after birth, in the absence of a placental leak, are consistent with neonatal infection.
Toxoplasma Gondii Antibody (IgM) S
T
79913
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic leak proof container
Transport Temperature
Refrigerated 3 days
Reject Criteria
Gross hemolysis • Hyperlipemia
MethodologyCLIA
Clinical Significance
Toxoplasmosis is a parasitic infection of humans caused by the protozoan toxoplasma gondii. In acute infections in immunocompetent hosts, only 10-20% of toxoplasma infections are symptomatic and usually present as asymptomatic cervical lymphadenopathy. The clinical picture may resemble infectious mononucleosis or CMV infection and the course is selflimited. Acute toxoplasmosis in immunodeficient hosts is the most common cause of intracerebral mass lesions. Serologic tests rarely confirm the diagnosis of toxoplasmic encephalitis in AIDS patients. Although a negative test result for specific IgG antibody diminishes the likelihood of toxoplasmic encephalitis, approximately 3% of patients with toxoplasmic encephalitis do not have toxoplasma antibody in their serum.
Transferrin Preferred Specimen(s)
Transport Container
208
891
1 mL serum
Plastic screw-cap vial
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Refrigerated 14 days
Gross hemolysis • Hyperlipemic • Plasma
Nephelometry
Transferrin concentration reflects the total iron-binding capacity (TIBC) and is used as an indicator of iron metabolism
Triglycerides Patient Preparation
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
896
Fasting specimen required
1 mL serum
Plastic screw-cap vial
Room temperature, stable for 5 day’s
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Serum triglyceride analysis has proven useful in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, and various endocrine disorders. In conjunction with high density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk.
Typhoid IgG/IgM, Rapid Test Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
79882
Serum: Collect blood specimen into collection tube(containing no anticoagulants in vacutainer®) by veinpuncture.
Plasma: Collect blood specimen into a blue or green top collection tube (EDTA, citrate or heparin, respectively in vacutainer®) by veinpuncture.
Red Top for serum; Lavender, blue or green Top for Plasma.
Refrigerated 5 days
Heat inactivated samples; Specimens which are grossly hemolyzed, lipemic or icteric; Microbial contaminated serum
Rapid Test
OnSite Typhoid IgG/IgM Rapid test is a simple and rapid laboratory test. The test simultane
ously detects and differentiates the IgG and IgM antibodies to S.typhi specific antigen thus to aid in the determination of current or previous exposure to the S.typhi.
Trypsin 30329
Preferred Specimen(s)
1 mL serum collected in a (red-top) tube (no gel)
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
MethodologyRadioimmunoassay
Clinical Significance
Trypsin (or trypsinogen) is considered a specific indicator of pancreatic damage. Increased values over the determined normal range may indicate inflammatory pancreatic condition.
TSH, Ultrasensitive 899
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 4 days, Refrigerated 30 days
MethodologyChemiluminescence
Clinical Significance
For differential diagnosis of primary, secondary, and tertiary hypothyroidism. This assay is a third generation product capable of detecting values as low as 0.01 mIU/L. Also useful in screening for hyperthyroidism. This assay allows adjustment of exogenous thyroxine dosage in hypothyroid patients and in patients on suppressive thyroxine therapy for thyroid neoplasia.
TSI (Thyroid Stimulating Immunoglobulin) Preferred Specimen(s)
30551
1 mL serum (red-top) tube
209
U
V
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
Plastic screw-cap vial
Refrigerated (cold packs)
Gross hemolysis • Hyperlipemia • Collected in a sodium heparin (green-top) tube
In vitro Bioassay/Luminescence
Graves Disease is a classic form of hyperthyroid disease, affecting approximately 0.4% of the population in the United States. It is caused by IgG immunoglobulins, collectively known as thyroid stimulating immunoglobulins (TSI). Patients who are candidates for antithyroid drug therapy may not respond to this treatment when TSI levels are markedly elevated. The
determination of TSI can also assist in predicting hyperthyroidism in neonates due to placental transmission of the immunoglobulins from a mother with hyperthyroidism.
UGT1A1 Gene Polymorphism (TA Repeat) Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
17813
5 mL whole blood collected in an EDTA (lavender-top) tube
Record the draw time and date on the tube. Ship immediately to maintain sample stability.
EDTA (lavender-top)
Room temperature
Gross hemolysis • Lipemia • Clotted blood received frozen
Fluorescent Polymerase Chain Reaction
This assay is intended for selection of colorectal cancer patients who would benefit most and experience the least toxicity from 5-FU, oxalipatin and irinotecan chemotherapy by determining the individual patient genotypes to guide chemotherapy choices in advanced
stage colorectal cancer
UPEP
See “Protein Electrophoresis, 24-Hour Urine (UPEP)”
Urea Nitrogen (BUN) Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 2 weeks
Frozen, stable 28 day’s
Hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Urea is the principle waste product of protein catabolism. BUN is most commonly measured in the diagnosis and treatment of certain renal and metabolic diseases. Increased BUN concentration may result from increased production of urea due to (1) diet or excessive
destruction of cellular proteins as occurs in massive infection and fevers, (2) reduced renal perfusion resulting from dehydration or heart failure, (3) nearly all types of kidney disease, and (4) mechanical obstruction to urine excretion such as is caused by stones, tumors,
infection, or stricture. Decreased urea levels are less frequent and occur primarily in advanced liver disease and in overhydration.
Urea Nitrogen, 24-Hour Urine U
V
294
973
Preferred Specimen(s)
10 mL urine
Transport Container
24-hour urine container
Instructions
Refrigerate during and after collection. Record the 24 hour-urine volume, on the test requisition form, as well as on the urine vial. Collect 24-hour urine in the presence of 10 grams boric acid.
Transport Temperature
Refrigerated, stable 1 week
Reject Criteria
Received at room temperature; Received frozen
MethodologySpecterophotometry
Clinical Significance
Urea is the principle waste product of protein catabolism. Urea nitrogen is most commonly measured in the diagnosis and treatment of certain renal and metabolic diseases. Increased urea nitrogen concentration may result from increased production of urea due to (1) diet
210
or excessive destruction of cellular proteins as occurs in massive infection and fevers, (2) reduced renal perfusion resulting from dehydration or heart failure, (3) nearly all types of kidney disease, and (4) mechanical obstruction to urine excretion such as is caused by
stones, tumors, infection, or stricture. Decreased urea levels are less frequent and occur primarily in advanced liver disease and in overhydration.
Urea Nitrogen, Random Urine Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Clinical Significance
10 mL Random urine with out preservative
Plastic leak proof container
Refrigerated, stable 1 week
Spectrophotometry (SP)
Urea is the principle waste product of protein catabolism. Urine Nitrogen is most commonly measured in the diagnosis and treatment of certain renal and metabolic diseases.
Uric Acid Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
78007
905
1 mL serum
Plastic screw-cap vial
Ambient 5 days, Refrigerated 14 days
Gross hemolysis • Anticoagulants other than heparin
Spectrophotometry (SP)
Serum uric acid measurements are useful in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and in patients receiving cytotoxic drugs.
Uric Acid , 24-Hour Urine 907
Includes
Creatinine, 24-Hour Urine
Preferred Specimen(s)
10 mL urine
Instructions
Collect urine without preservative. Do not acidify the specimen. Do not include first morning specimen; collect all subsequent voidings. The last sample collected should be the first morning specimen voided the following morning at the same time as the previous morning’s first voiding. Record 24-hour urine volume on test request form and urine vial. Please submit a 10mL aliquot of a 24-hour condition and aliquot unpreserved specimen prior to addition of any acid.
Transport Container
Plastic screw-cap container
Transport Temperature
Refrigerated 7 days
Refrigerated, stable 1 week
Reject Criteria
Received frozen • Urine Received with preservative
MethodologySpectrophotometry
Clinical Significance
Urine uric acid may supplement serum uric acid testing when trying to identify conditions in which there is alteration of uric acid production or excretion, e.g., gout, leukemia, renal disease. The amount of uric acid excreted may be useful in treating asymptomatic hyperuricemia. Measurement of urine uric acid is important in the investigation of urolithiasis.
Uric Acid, Random Urine 14580
Preferred Specimen(s)
10 mL Random urine with out preservative
Transport Container
Plastic leak proof container
Transport Temperature
Refrigerated 7 days
Refrigerated, stable 1 week
Reject Criteria
Received frozen • Urine Received with preservative
Methodology
Spectrophotometry (SP)
Clinical Significance
Urine uric acid may supplement serum uric acid testing when trying to identify conditions in which there is alteration of uric acid production or excretion, e.g., gout, leukemia, renal disease. The amount of uric acid excreted may be useful in treating asymptomatic
hyperuricemia. Measurement of urine uric acid is important in the investigation of urolithiasis.
211
U
V
Urinalysis, Complete Includes
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
5463
Macroscopic and Microscopic Examinations
10 mL urine - Urinalysis transport tube (yellow-top, blue fill line, preservative tube)
Encourage clean catch mid stream samples to minimize contamination and improve accuracy. Label the sample appropriately and store at room temperature until pickup.
Note: The Yellow-top, blue line tube cannot be used for collection and transport of specimens for urine culture. ***This order code does not include a reflex to culture*** If culture is being ordered separately, submit separate specimen (10 mL urine gray-top tube).
Yellow-top, blue fill line urinalysis transport tube
untreserved - Room temperature, 24 hours
preserved: Refrigerated, 72 hours
Pediatric Unpreserved: Refrigerated (cold packs)
Unpreserved specimen (adults) received after 72 hours
Reagent Impregnated Strips/Tablets/Microscopic Examination
Dipstick urinalysis is important in accessing the chemical constituents in the urine and the relationship to various disease states. Microscopic examination helps to detect the presence of abnormal urine cells and formed elements.
Urine, Routine Culture
See “Culture, Urine, Routine”
UroVysion™
See “Vaginosis/Vaginitis Panel”
See “FISH, Vysis® UroVysion™, Bladder Cancer”
Valproic Acid, Total 79071
Preferred Specimen(s)
2.0 mL Serum
Instruction
Record total volume and collection time on specimen, container and requisition.
Transport Container
Plastic Screw cap vial
Transport Temperature
Ambient 8 hrs, Refrigerated 2 days
MethodologyImmunoassay
Clinical Significance
Valproic acid is used as an anticonvulsant to treat certain types of seizures, to prevent migrane head aches, and to treat various psychiatric illnesses suchas bipolar disorder and aggression. Therapeutic drug monitoring is useful to optimize dose and avoid
VIP
See “Vasoactive Intestinal Polypeptide (VIP)”
Vitamin B12 U
V
927
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Ambient 5 days, Refrigerated (cold packs) 8 days
Reject CriteriaHemolysis
MethodologyChemiluminescence
Clinical Significance
Vitamin B12 is decreased in pernicious anemia, total or partial gastrectomy, malabsorption and certain congenital and biochemical disorders. Its deficiency causes neurological 212
disturbances and increases the serum level of homocysteine which is a cardiovascular risk factor.
Vitamin B12 and Folate Panel, Serum 7065
Preferred Specimen(s)
2 mL serum
Instructions
Folate is light sensitive. Minimize exposure to light during sample handling and storage.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs) 5 days
Reject CriteriaHemolysis
MethodologyChemiluminescence
Clinical Significance
Folic acid deficiency is common in pregnant women, alcoholics, patients with diets that do not include raw fruits and vegetables, and people with structural damage to the small intestine. The most reliable and direct method of diagnosing folate deficiency is the determination of folate levels in both erythrocytes and serum. Low folic acid levels, however, can also be the result of a primary vitamin B12 deficiency that decreases the ability of cells to take up folic acid. B12 is decreased in pernicious anemia, total or partial gastrectomy,
malabsorption and certain congenital biochemical disorders.
Vitamin D, 1,25-dihydoxy 79280
Preferred Specimen(s)
3 mL serum
Instructions
The preferred specimen transport temperature is frozen. Room temperature and refrigerated transportation
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature
MethodologyELISA
Clinical Significance
Vitamin D originating from dietary and endogenous sources is converted to 25-hydroxy
vitamin D in the liver, and subsequently to 1-, 25-dihydroxyvitamin D in the kidney. Deficiencies of 1-,25-dihydroxyvitamin D, the most active form, cause hypocalcemia, osteomalacia, and related disorders. Measurement is useful in: differentiating primary hyperparathyroidism from hypercalcemia of cancer; distinguishing between vitamin D dependent and vitamin D resistant rickets; monitoring vitamin D status of patients with chronic renal disease; and, assessing compliance to therapy.
Vitamin D, 25-Hydroxy, CLIA 78917
Includes
D2, D3 and Total Vitamin D, 25-Hydroxy
Preferred Specimen(s)
1 mL serum
Instructions
Collect blood by venipuncture into plain tubes (without anticoagulant). Separate the serum from the cells immediately.
Transport Container
Plastic screw-cap vial
Transport Temperature
Frozen; 2-8oC
Reject Criteria
Gross hemolysis • Gross lipemia • Plasma
MethodologyCLIA
Clinical Significance
This assay should be used to monitor patients taking vitamin D supplements as well as to diagnose Vitamin D deficiency. The measurement of 25-OH Vitamin D is the best indicator of Vitamin D status in the body.
This assay employs chemiluminescence and measures the total of 25-OH D2 (the analog form used to treat 25-OH D3 deficiency ) and 25-OH D3( the endogenous form of the vitamin).
Vysis® UroVysion™
See “FISH, Vysis® UroVysion™, Bladder Cancer”
Widal Test (Tube Method) Preferred Specimen(s)
Instructions
17323
3ml serum
Separate serum from cells as soon as possible
213
W
Z
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated, 48 hours
Reject Criteria
Received frozen; Room temperature
Methodology
Tube Method
Clinical Significance
The Widal test is a presumptive serological test for Enteric fever or Undulant fever that may be caused by Salmonella infections (S. typhi, S. paratyphi A & B). The most important causative factor in India is S. typhi. The antibodies are tested against two types of antigens,
the protein H (flagellar) and the polysaccharide O (somatic) antigen. The H antigen is a protein and more antigenic and hence gives higher antibody titers. The H antigen is however relatively nonspecific due to due to shared antigens amongst entero-bacteriaceae. The O
polysaccharide antigen gives lower titers and is more specific. A two fold rise in titer is
diagnostic of typhoid fever. A single reading of titer more than 240 is also considered as diagnostic.
Widal Slide test (Rapid) 79323
Preferred Specimen(s)
3ml serum
Instructions
Separate serum from cells as soon as possible
Transport Container
No additive (red-top) tube
Transport Temperature
Refrigerated 48 hours
Reject Criteria
Received frozen; Room temperature
Methodology
Agglutination on slide
Clinical Significance
The Widal test is a presumptive serological test for Enteric fever or Undulant fever that may be caused by Salmonella infections (S. typhi, S. paratyphi A & B). The most important causative factor in India is S. typhi. The antibodies are tested against two types of antigens,
the protein H (flagellar) and the polysaccharide O (somatic) antigen. The H antigen is a protein and more antigenic and hence gives higher antibody titers. The H antigen is however relatively nonspecific due to due to shared antigens amongst entero-bacteriaceae. The O
polysaccharide antigen gives lower titers and is more specific. A two fold rise in titer is
diagnostic of typhoid fever. A single reading of titer more than 240 is also considered as diagnostic.
W
214
215
216
Tests Performed in US Lab
217
218
Acetylcholine Receptor Binding Antibody
206
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Limitations
1mL serum
Plastic screw-cap vial
Room temperature
Hemolysis • Lipemia • Contaminated specimens • Icteric specimens • Radioactive compounds from in vivo testing • Plasma
Radioimmunoassay (RIA)
Antibodies may not be found in congenital myasthenia.
Reference Range(s)
Negative
<0.30 nmol/L
Equivocal
0.31-0.49 nmol/L
Positive
>0.50 nmol/L
Acetylcholine Receptor Blocking Antibody
34459
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
MethodologyImmunoassay
Limitations
Antibodies may not be found in congenital myasthenia
ACTH, Plasma 211
Patient Preparation
Collect specimen between 7 A.M. and 10 A.M. If drawn at any other time, the reference ranges do not apply.
Preferred Specimen(s)
1.5 mL plasma collected in an EDTA (lavender-top) tube
Instructions
Centrifuge immediately after collection to separate plasma from cells. Transfer plasma to a plastic specimen transport container and mark the specimen type as plasma on the container. Freeze immediately.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed • Gross hemolysis
MethodologyImmunoassay
Limitations
With patients receiving more than 5mg/day of biotin, a sample should be taken no sooner than eight hours after previous dose. Patients treated with monoclonal mouse antibodies may have inaccurate results. High titer of antibodies such as streptavidin and ruthenium may cause interference. Due to its correlation with cortisol levels, ACTH concentration is affected by stress. Any single measure may be within the reference range for patients with increased production (Cushing’s disease) or minimal production of ACTH.
Reference Range(s)
<3 Years
Not established
3-17 Years
9-57 pg/mL
>18 Years male
7-50 pg/mL
>18 Years female
5-27 pg/mL
ACTIN (Smooth Muscle) Antibody (IgG)
15043
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
0.5mL serum
Plastic screw-cap vial
Refrigerated (cold packs)
Gross hemolysis • Lipemia • Received room temperature • Microbially contaminated serum • Specimens containing heavy, visible particulate
Enzyme Linked Immunosorbent Immunoassay (ELISA)
Reference Range(s)
<20 U
Negative
20-30 U
Weak positive
>30 U
High positive
219
A
B
A
B
This ELISA assay is based on purified F-Actin IgG antibodies. IgG antibodies to F-Actin are present in approximately 75% of patients with autoimmune hepatitis type 1, 65% with autoimmune cholangitis, 30% with p rimary biliary cirrhosis, and 2% of the healthy population.
Activated Protein C-Resistance
22
Preferred Specimen(s)
2 mL plasma collected in a 3.2% sodium citrate (light blue-top) tube
Transport Temperature Frozen
Reject Criteria
Hemolysis • Thawed Plasma • Received room temperature • Received refrigerated • Clotted specimen • Serum
Methodology
RVVT Based Clot Assay
Clinical Significance
To screen for APC-R associated with venous thromboembolic disorders
Aldosterone, Serum LC/MS/MS
17181
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Limitations
1mL serum collected in a red-top tube (no gel)
Separate serum after clotting. Do not submit glass tubes. Draw “upright” samples at least 1/2 hour after patient sits up.
Plastic screw-cap vial
Room temperature
Serum Separator Tube (SST‰) • Glass tubes
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
Aldosterone concentration varies based on body position and sodium intake. 24-hour urine specimens for aldosterone are an alternative.
Reference Range(s)
Adult
Pediatric
Infants
Tanner Stages
Anti-Mullerian Hormone AssessR™
Upright 8:00-10:00 A.M.
<28 ng/dL
Upright 4:00-6:00 P.M.
<21 ng/dL
Supine 8:00-10:00 A.M.
3-16 ng/dL
1-12 Months
2-70 ng/dL
1-4 Years
2-37 ng/dL
5-9 Years
<9 ng/dL
10-13 Years
<21 ng/dL
14-17 Years
<35 ng/dL
Premature (31-35 Weeks)
<144 ng/dL
Term
<217 ng/dL
II-III Males
1-13 ng/dL
II-III Females
2-20 ng/dL
IV-V Males
3-14 ng/dL
IV-V Females
4-32 ng/dL
16842
Preferred Specimen(s)
1 mL serum collected in a red-top tube (no gel)
Collection Instructions Separate serum from clot and ship frozen. Frozen SST® tubes are not acceptable
Transport TemperatureFrozen
Reject Criteria
Unspun Serum Separator Tube (SST®)
Methodology
Immunoassay (IA)
Clinical Significance
AMH/MIS may be used in the investigation of ovarian reserve and the perimenopausal transition in women; the detection and onset of puberty in the young, the differential diagnosis of intersex disorders; the diagnosis of cryptorchidism and anorchidism, and the evaluation of male gonadal function in all ages.
220
Antithrombin III Antigen
5158
Patient Preparation
Patient should abstain from anabolic steroids, Gemfibrozil, Warfarin (Coumadin‰), heparin therapy, asparaginase, estrogens, gestodene and oral contraceptives optimally for 3 days prior to specimen collection. Overnight fasting is preferred.
Preferred Specimen(s)
1mL frozen plasma collected in a 3.2% sodium citrate (light blue-top) tube
See Coagulation in Specimen Collection and Handling
Instructions
Platelet-poor plasma: Centrifuge light blue-top tube for 15 minutes at approximately 1500g within 60 minutes of collection. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Plasma must be free of platelets (<10,000/uL). Freeze immediately and ship on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received thawed • Received room temperature • Received refrigerated • Plasma collected in a 3.8% sodium citrate (light blue-top) tube
Methodology
Fixed Rate Time Nephelometry
Limitations
Falsely elevated results may be caused by heparin cofactor II.
Reference Range(s)
See Laboratory Report
Aspergillus IgG, IgA, IgM, EIA (9941)
Preferred Specimen(s)
Specimen Container
Transport Temperature Methodology 10239
1mL Serum
Serum: Red-top (no gel)
Serum: Refrigerated preferred; Room temperature acceptable;
_Frozen acceptable
Enzyme Immunoassay
Aspergillus fumigatus (M3) IgE
60251
Preferred Specimen(s)
0.3mL serum
Transport Temperature Room temperature
Methodology Immunoassay
BRAF Mutation Analysis
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Reference Range(s)
16767
Formalin-fixed paraffin embedded tissue
Whole blood (acceptable): Collect 5 mL (minimum 4 mL) whole blood in an EDTA (lavender-top) tube.
Formalin-fixed, paraffin embedded tissue block
Room temperature
Received frozen
Direct Sequencing
Negative
Brucella Antibodies (IgG, IgM)
10566
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
MethodologyImmunoassay
Limitations
Previous vaccination may affect results
C1 Inhibitor, Functional
297
Preferred Specimen(s)
1 mL serum collected in a red-top tube (no gel)
Instructions
Freeze serum within one hour of time drawn. Do not use gel barrier tubes. Do not submit the sample in a glass tube. Do not thaw.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
221
A
B
Reject Criteria
Gross hemolysis • Lipemia • Received thawed • Received room temperature • Received refrigerated • Serum Separator Tube (SST‰) • Glass tubes • CSF
MethodologyImmunoassay
Limitations
Fifteen percent of patient with the inherited form of the disease will test within range.
Reference Range(s)
C
D
>68 %
Normal
41-67 %
Equivocal
<40 %
Abnormal
Less than 40% of the reference functional activity indicates a likely diagnosis of hereditary angioedema or acquired C1 inhibitor deficiency.
C1 Inhibitor, Protein
Patient Preparation
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Limitations
Reference Range(s)
298
Overnight fasting is preferred
1mL serum
Collect on ice. Chill in ice bath during clotting. Separate from clot with minimum centrifugation. Refrigerate serum immediately. Avoid hemolysis.
Plastic screw-cap vial
Refrigerated (cold packs)
Received room temperature • Pleural fluid • Synovial fluid
Fixed Rate Time Nephelometry
Fifteen percent of patient with the inherited form of the disease will test within range.
11-26 mg/dL
CA 27.29
29493
Preferred Specimen(s)
1 mL serum
Transport Container
Serum Separator Tube (SST‰)
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis
MethodologyImmunoassay
Limitations
CA 27.29 is not intended as a screening test
Calcitonin30742
Patient Preparation
Overnight fasting is preferred
Preferred Specimen(s)
1mL serum
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Received refrigerated • Gross hemolysis
MethodologyImmunoassay
Limitations
Basal concentrations of >100 pg/mL have been found to have 100% positive predictive value for medullary thyroid cancer. Lower concentrations may be observed in some patients with clinically apparent medullary thyroid cancer.
Catecholamines, Fractionated, 24-Hour Urine without Creatinine Patient Preparation
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Methodology
Limitations
222
318
It is preferable for the patient to be off medications for a minimum of 18-24 hours prior to collection however, common antihypertensives (diuretics, ACE inhibitors, calcium channel blockers, alpha and beta blockers) may cause minimal or no interference. Patient should avoid
tobacco, tea, coffee, and strenuous exercise for 8-12 hours prior to collection.
10mL aliquot from a 24-hour collection preserved with 6N HCl at the start of collection. Unpreserved specimens must be frozen.
See Urine in the Blood, Urine and Stool section of Specimen Collection and Handling
Record total volume on both the transport container and the test requisition
Plastic urine container
Room temperature (if preserved) • Frozen acceptable (if unpreserved)
High Performance Liquid Chromatography (HPLC)
Recent surgery, traumatic injury, upright posture, cold, anxiety, pain, clonidine withdrawal, and concurrent acute or chronic illness may produce elevated results. Requires accurate 24-hour urine collection.
Reference Range(s)
Norepinephrine
Epinephrine
Dopamine
Total Catecholamines
3-8 Years
5-41 ug/24 h
9-12 Years
5-50 ug/24 h
13-17 Years
12-88 ug/24 h
>17 Years
15-100 ug/24 h
3-8 Years
1-7 ug/24 h
9-12 Years
<8 ug/24 h
13-17 Years
<11 ug/24 h
>17 Years
2-24 ug/24 h
3-8 Years
80-378 ug/24 h
9-12 Years
51-474 ug/24 h
13-17 Years
51-645 ug/24 h
>17 Years
52-480 ug/24 h
3-8 Years
9-51 ug/24 h
9-12 Years
9-71 ug/24 h
13-17 Years
13-90 ug/24 h
>17 Years
26-121 ug/24 h
Chromogranin A, Electrochemiluminescence
Preferred Specimen(s)
Specimen Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
C
D
16379
0.8 mL serum
Serum: SST (red-top)
Room temperature
Gross hemolysis • Gross lipemia • Gross icteria
Electrochemiluminescence (ECLIA)
Chromogranin A has been identified in a number of normal and neoplastic endocrine tissues.
Collagen Type I C-Telopeptide (CTx)
17406
Patient Preparation
Fasting is required. Fasting morning collection 8-10 A.M. (diurnal variations cause elevated levels at night).
Preferred Specimen(s)
1 mL serum
Instructions
Allow blood to clot (10-15 minutes) at room temperature. Centrifuge and separate the serum from the cells. Freeze as soon as possible.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Moderate/gross hemolysis • Gross lipemia • Non-fasting specimens • Gross icteric
Methodology
Electrochemiluminescent Immunoassay
Reference Range(s)
Adult Male
Adult Female
Pediatric Male
18-29 Years
87-1200 pg/mL
30-39 Years
70-780 pg/mL
40-49 Years
60-700 pg/mL
50-68 Years
87-345 pg/mL
18-29 Years
60-640 pg/mL
30-39 Years
60-650 pg/mL
40-49 Years
40-465 pg/mL
5-9 Years
574-1849 pg/mL
10-13 Years
519-2415 pg/mL
14-17 Years
435-2924 pg/mL
223
Pediatric Female
C
D
5-9 Years
574-1849 pg/mL
10-13 Years
519-2415 pg/mL
14-17 Years
242-1291 pg/mL
Cortisol, Free, LC/MS/MS, 24-Hour Urine 11280
Preferred Specimen(s) 2mL Urine
Specimen ContainerUrine
_24-hour urine container (preferred)
_No preservative (preferred)
_25 mL 6N HCl
_10 mL conc. glacial acetic acid
_10 g Boric acid
Transport Temperature
Urine: Refrigerated preferred; Room temperature
_unacceptable; Frozen acceptable
Methodology Liquid Chromatography, Tandem Mass Spectrometry (LC/MS/MS)
Clinical Significance
Urinary Free Cortisol is useful in the detection of patients with Cushing’s syndrome for whom Free Cortisol concentrations are elevated.
Cryptococcus Antigen Screen with Reflex to Titer
11197
Preferred Specimen(s)
1 mL CSF or 2 mL serum
Transport Container
CSF: Sterile screw-cap vial
Serum: Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Glass tubes
MethodologyImmunoassay
Limitations
Patients with capnocytophagna canimorsus and tichosporon beigelli infections may test falsely-positive.
Reference Range(s)
Not detected
Cytomegalovirus (CMV) DNA, Qualitative, Real Time - PCR
10601
Preferred Specimen(s)
1mL whole blood collected in an EDTA (lavender-top) tube or 1mL plasma collected in an EDTA (lavender-top) tube or serum, CSF, amniotic fluid, random urine or fresh (unfixed) tissue
Instructions
Whole blood: Collect whole blood in sterile tubes containing EDTA or ACD as anticoagulant. Store refrigerated. Do not freeze whole blood.
Plasma: Collect blood in sterile tubes containing EDTA or ACD as anticoagulant or in Plasma Preparation Tubes (PPT). Store collected whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-capped
tubes and store refrigerated or frozen. If blood is collected in a PPT tube, centrifuge within 2 hours of collection and store refrigerated or frozen. It is not necessary to transfer the plasma from a PPT tube to aliquot tubes.
Serum, CSF, amniotic fluid, urine and tissue: Collect in a sterile container and store refrigerated or frozen.
Transport Container
See Instructions
Transport Temperature
Refrigerated (cold packs): Whole blood, plasma, amniotic fluid, CSF and serum
Frozen: Tissue or random urine
Reject Criteria
Frozen whole blood • Heparin whole blood • Heparin plasma• Synovial fluid • Vitreous fluid • Eye swab • Lesion (vesicle) aspirate swab • Fluid • Bone marrow • Buffy coat • Sputum • Tissue biopsy • Nasopharyngeal lavage/wash • Tracheal lavage/wash • Nasal/nasopharyngeal swab • Pericardial fluid • Peritoneal fluid • Pleural fluid • 24 hour urine • Bronchial lavage/wash
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Reference Range(s)
Not detected
224
Dihydrotestosterone, LC/MS/MS
Preferred Specimen(s) Alternative Specimen(s) Transport Temperature Reject Criteria Methodology Clinical Significance
90567
0.6 mL serum collected in a red-top (no gel) tube
Plasma collected in an EDTA tube
Room temperature
Moderate hemolysis • Gross hemolysis • Lipemia • SST tubes
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
DHT is a potent androgen derived from testosterone via 5-alpha-reductase activity. 5-alpha-reductase deficiency results in incompletely virilized males (phenotypic females). This diagnosis is supported by an elevated ratio of testosterone to DHT.
Epidermal Growth Factor Receptor (EGFR) Mutation Analysis
Preferred Specimen(s)
Transport Temperature Reject Criteria
Methodology
Clinical Significance
Formalin fixed paraffin embedded tissue block
Room temperature
Thawed tissue • Fresh tissue • Non-fixed tissue
Polymerase Chain Reaction (PCR) • Sequencing
This test was developed and its performance characteristics have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.
Quest Diagnostics will offer a DNA sequencing test to identify patients with those specific mutations in the TK domain of the EGFR gene (exons 18-21). With this information, physicians will be able to select those patients who are most likely to respond to targeted lung cancer therapy, including Iressa and Tarceva. Physicians can also use this information to predict drug resistance as identified by those patients who do not have those mutations. We may also be able to identify novel mutations, and may be able to provide this test for other EGFR targeted drugs emerging from pharmaceutical pipelines.
EML4-ALK Gene Fusion, PCR
Preferred Specimen(s)
Specimen Container
Transport Temperature
Reject Criteria
Methodology
Clinical Significance
16344
Formalin fixed paraffin embedded tissue
Formalin-fixed paraffin embedded tissue block
Room temperature
Frozen tissue blocks
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Recently, inhibitors of anaplastic lymphoma kinase (ALK) have been used successfully in treating patients harboring gene fusions between echinoderm microtubule-associated protein-like 4 (EML4) and ALK. This is a reverse transcription PCR-based exon scanning approach to encompass fusion variants spanning nearly the entire EML4 gene.
Endomysial Antibody Screen (IgA) with Reflex to Titer
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Reference Range(s)
16460
15064
1mL serum
Plastic screw-cap vial
Refrigerated (cold packs)
Immunofluorescence Assay (IFA)
Negative
Epstein-Barr Virus Viral Capsid Antigen (VCA) Antibody (IgG)
8474
Preferred Specimen(s)
1 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis • Gross lipemia • Icteric
MethodologyImmunoassay
Reference Range(s)
Index
Interpretation
<0.90
Negative
0.91-1.09
Equivocal
>1.10
Positive
225
E
F
Erythropoietin427
Preferred Specimen(s)
1 mL serum
Transport Container
Serum Separator Tube (SST‰)
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis
MethodologyImmunoassay
Reference Range(s)
E
F
<3 Weeks
Not established
3 Weeks-2 Months
5.0-13.0 mIU/mL
3 Months-16 Years
9.0-28.0 mIU/mL
>16 Years
4.1-19.5 mIU/mL
Estradiol, Ultrasensitive, LC/MS/MS
30289
Preferred Specimen(s)
0.5mL serum collected in a red-top tube (no gel)
Instructions
Specify age and sex on test requisition
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Serum Separator Tube (SST‰)
Methodology
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Reference Range(s)
Adult
Male
<29 pg/mL
Female
Follicular Stage
39-375 pg/mL
Luteal Stage
48-440 pg/mL
Postmenopausal
<10 pg/mL
Pediatric
Male (pg/mL)
Female (pg/mL)
Pre-pubertal (1-9 Years)
≤4
≤16
10-11 Years
≤12
≤65
12-14 Years
≤24
≤142
15-17 Years
≤31
≤283
Estrogen, Total, Serum
Preferred Specimen(s)
Alternative Specimen(s) Transport Temperature Reject Criteria Methodology Clinical Significance
1mL serum
Plasma collected in: Lithium heparin (green-top), sodium heparin (green-top), 3.2% sodium citrate (light blue-top), ACD solution B (yellow-top), potassium oxalate (gray-top), sodium fluoride (gray-top), PPT potassium EDTA (white-top), EDTA (lavender-top) or EDTA (royal blue-top) tube
Refrigerated (cold packs)
Received room temperature
Extraction • Radioimmunoassay (RIA)
Estrogens are secreted by the gonads, adrenal glands, and placenta. Total estrogens provide an overall picture of estrogen status for men and women.
Factor IX Activity, Clotting Preferred Specimen(s)
Instructions
226
439
352
3 mL platelet poor 3.2% sodium citrate-anticoagulated plasma (collected in light blue-top tube), separated and frozen immediately
See Coagulation in Specimen Collection and Handling
Draw blood in (light blue-top) tube containing 3.2% sodium citrate. Mix gently by inverting 3-4 times. Centrifuge 15 minutes at 2500-3500 rpm. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet buffy layer and transfer into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Plasma must be free of platelet (<10,000/uL). Freeze immediately and ship on dry ice.
Transport Container
Plastic screw - cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Received refrigerated • Received thawed • Hemolysis
Methodology
Photometric Clot Detection
Limitations
Factor IX inhibitors, including alloantibodies that develop post-replacement therapy and autoantibodies that develop spontaneously, can cause falsely low factor IX levels.
Factor V (Leiden) Mutation Analysis
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Reference Range(s)
17900
5 mL whole blood collected in an EDTA (lavender-top) tube
Plastic screw-cap vial
Room temperature
Received frozen
Polymerase Chain Reaction (PCR) • Oligonucleotide Ligation Assay • Fluorescent Microspheres
The Factor V Leiden (R506Q) mutation [NM 000130.2: c. 1601GA (p.R534Q)] in the Factor V gene is one of the most common causes of inherited thrombophilia. This mutation causes resistance to degradation of activated Factor V protein by Activated Protein C (APC). The Factor V Leiden (R506Q) mutation is detected by Polymerase Chain Reaction (PCR) amplification of the Factor V gene, followed by an Oligonucleotide Ligation Assay (OLA). The biotinylated reaction products are hybridized to microspheres and allelic discrimination is performed by identifying microspheres and measuring the associated reported fluorescence. Since genetic variation and other factors can affect the accuracy of direct mutation testing,
these results should be interpreted in light of clinical and familial data.
Fibrinogen Degradation Products (FDP), Semi Quantitative
458
Preferred Specimen(s)
1 mL platelet-poor anticoagulated plasma collected in a 3.2% sodium citrate (light blue-top) tube
See Coagulation in Specimen Collection and Handling
Instructions
Draw blood in a 3.2% sodium citrate (light blue-top) tube, mix gently by inverting 3-4 times. Centrifuge 15 minutes at 2500-3500 RPM. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and transport on dry ice.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Clotted
Methodology
Latex Agglutination
Reference Range(s)
<5 ug/mL
FISH, ALK, 2p23 Rearrangement
Preferred Specimen(s)
Alternative Specimen(s) Transport Temperature Methodology Clinical Significance
3mL bone marrow collected in transport media or 5 mL whole blood collected in sodium heparin (green-top) tube
Bone marrow collected in sodium heparin (green-top), royal blue-top), or lead-free (tan-top) tube • Whole blood collected in Sodium heparin (royal blue-top) or lead-free (tan-top) • 5 X 5 m Tumor tissue collected in transport media formalin fixed, paraffin embedded tissue block • 5 X 5 mm Lymph node collected in transport media formalin fixed, paraffin embedded tissue block
Room temperature
Fluorescence In-Situ Hybridization (FISH)
The anaplastic large cell lymphoma specific chromosomal rearrangements of 2p23 can be proved by FISH. The patients carrying t (2; 5) or ALK fusion protein have been reported to have a good response to chemotherapy and favorable outcome.
FISH, EGFR
Preferred Specimen(s)
Specimen Container
Transport Temperature
16114
19041
Formalin fixed paraffin embedded tissue
Formalin fixed paraffin embedded tissue block
Room temperature
227
E
F
Methodology
Clinical Significance
Fluorescence In-Situ Hybridization (FISH)
The epidermal growth factor receptor (EGFR) is a cellular transmembrane receptor with tyrosine kinase enzymatic activity that plays a key role in human cancer. EGFR-dependent signaling is involved in cancer cell proliferation, apoptosis, angiogenesis, invasion and metastasis. Targeting the EGFR is a valuable molecular approach in cancer therapy.
Gastrin478
Patient Preparation
Overnight fasting (12 hours)
Preferred Specimen(s)
1mL frozen serum
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Gross hemolysis • Gross lipemia • Received thawed • Grossly icteric
MethodologyImmunoassay
Reference Range(s)
G
H
<5 Years
Not established
5-17 Years
13-64 pg/mL
>17 Years
<100 pg/mL
Glomerular Basement Membrane Antibody (IgG) (GBM Antibody)
257
Preferred Specimen(s)
1mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
MethodologyImmunoassay
Limitations
Weakly positive results (5-30 EU/mL) may occur in patients who do not have antiglomerular basement membrane antibody-mediated disease.
Reference Range(s)
<1.0 AI
Helicobacter pylori Antibody (IgM)
Preferred Specimen(s)
Transport Temperature
Methodology
Clinical Significance 51771
1 mL serum
Room temperature
Enzyme Immunoassay (EIA)
Colonization with H. pylori is associated with increased risk of patients developing gastritis, peptic ulcer disease, and gastric adenocarcinoma. Serologic testing is recommended only for symptomatic patients. Antibody IgM may be not be elevated in many infected individuals.
Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations 10529
Preferred Specimen(s)
1mL plasma collected in a PPT potassium EDTA (white-top) tube
Instructions
Plasma: Collect blood in sterile tubes containing EDTA anticoagulant; either 0.15% solution
v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (plasma preparation tube or PPT tube with plasma separator-gel, preferred). Store whole blood at room temperature and separate plasma from cells within 2 hours of collection. Transfer plasma to sterile, plastic, screw-cap vials and store at -18° C or colder.
Serum: Collect blood in sterile tubes with no anticoagulants; plastic Serum Separator Tubes (SST‰s) are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-cap vials and store refrigerated or frozen. Ship frozen.
If blood is collected in a PPT tube, centrifuge preferably within 2 hours of collection as before but it is not necessary to transfer plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport
and storage. The PPT is plastic and hence plasma can be stored and shipped frozen in the original tube. Avoid repeated freezing and thawing of specimen. Ship frozen.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Unspun PPT tube
Methodology
Polymerase Chain Reaction (PCR) • Sequencing
228
Limitations
Reference Range(s)
Results obtained from immunosuppressed patients should be interpreted with caution.
See Laboratory Report
Hepatitis C Viral RNA, Genotype, LiPA‰ 37811
Preferred Specimen(s)
2 mL plasma collected in a PPT potassium EDTA (white-top) tube
Instructions
Plasma (preferred): Collect blood in sterile tubes containing EDTA anticoagulant, either 0.15% solution v/v final EDTA K3 (standard EDTA tube) or 9 mg spray-dried EDTA K2 (Plasma Preparation Tube or PPT tube with plasma separator-gel, preferred). Blood collected in tubes
containing ACD anticoagulant are acceptable but will yield results approximately 15% lower when compared to EDTA tubes due to the dilution effect of the 1.5 mL of anticoagulant used in the tube. Store whole blood at room temperature and separate plasma from cells within 6 hours of collection. Transfer plasma to sterile, plastic, screw-capped aliquot tubes and store at -18°C or colder.
Do not clarify plasma by filtration or further centrifugation. Avoid repeated freezing and thawing of specimen.
Note: If blood is collected in a PPT tube, centrifuge within 6 hours of collection as before, but it is not necessary to transfer the plasma to aliquot tubes. Following centrifugation, a gel barrier maintains separation of plasma from cellular components during specimen transport and storage, and unlike standard Vacutainer‰ Brand blood collection tubes, the PPT tube is plastic and hence the plasma can be shipped and stored frozen in the original tube.
Serum (acceptable): Collect blood in sterile tubes with no anticoagulants; Serum Separator Tubes (SST‰s) are recommended. Allow blood to clot at room temperature and separate serum from cells within 6 hours of collection. Transfer serum to sterile, plastic screw-capped, aliquot tubes and store at -18°C or colder. Avoid repeated freezing and thawing of specimen.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Received room temperature • Unspun Serum Separator Tube (SST‰) • Unspun PPT tubes
Methodology
Multi-Probe Reverse Hybridization
Reference Range(s)
See Laboratory Report
Hereditary Hemochromatosis, DNA, Mutation Analysis
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Limitations
G
H
35079
5 mL whole blood collected in an EDTA (lavender-top) tube
EDTA (lavender-top) tube
Room temperature
Received frozen
Polymerase Chain Reaction (PCR) • Fluorescent Restriction Fragment Length Polymorphism
Expression of C282Y/C282Y homozygosity is variable. Some individuals who fail to meet the diagnostic criteria for hemochromatosis are homozygous for the gene. If these mutations are not found by the testing procedure, it does not mean that the risk of carrying or developing HH is not present. It simply means that these specific mutations have not been found, although other mutations may be present. It is also possible that such a patient may have secondary hemochromatosis, due to nongenetic causes, that would not be detected by this test.
Herpes Simplex Virus, Type 1 and 2 DNA, Real-Time PCR 34257
Preferred Specimen(s)
1mL CSF in sterile leak-proof container only
Instructions
CSF: Collect in a sterile container and store refrigerated or frozen
Swab: Submit in M4 or V-C-M transport medium
Swab (dry or in transport media): Store refrigerated or frozen
Serum: Collect blood in sterile tubes with no anticoagulants; Serum Separator Tubes (SST‰s)
are recommended. Allow blood to clot at room temperature and separate serum from cells within 2 hours of collection. Transfer serum to sterile, plastic screw-capped aliquot tubes and store refrigerated or frozen.
Plasma: EDTA (lavender-top) or ACD-B (yellow-top) tube
Whole blood: EDTA (lavender-top) or ACD-B (yellow-top) tube
Transport Container
Sterile leak-proof container
Transport Temperature
Refrigerated (cold packs)
Reject CriteriaSputum
229
Methodology
Reference Range(s)
Real-Time Polymerase Chain Reaction (RT-PCR)
Not detected
Hydroxyprogesterone, 17 Alpha, Serum
17180
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
0.5 mL serum collected in a red-top tube (no gel)
Separate serum after clotting. Ship serum refrigerated or frozen. Do not submit glass tubes.
Plastic screw-cap vial
Refrigerated (cold packs)
Serum Separator Tube (SST‰) • Glass tubes • Received room temperature
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Reference Range(s)
Adult Male
G
H
Adult Female
18-30 Years
32-307 ng/dL
31-40 Years
42-196 ng/dL
41-50 Years
33-195 ng/dL
51-60 Years
37-129 ng/dL
Follicular Phase
<185 ng/d
Luteal Phase
<285 ng/dL
Postmenopausal
<45 ng/dL
Pregnancy
Pediatric
Infant
Tanner Stages
First Trimester
78-457 ng/dL
Second Trimester
90-357 ng/dL
Third Trimester
144-578 ng/dL
1-12 Months
11-170 ng/dL
1-4 Years
4-115 ng/dL
5-9 Years
<90 ng/dL
10-13 Years
<169 ng/dL
14-17 Years
16-283 ng/dL
Premature (31-35 Weeks)
<360 ng/dL
Term (3 Days)
<420 ng/dL
II-III Male
12-130 ng/dL
II-III Female
18-220 ng/dL
IV-V Male
51-190 ng/dL
IV-V Female
36-200 ng/dL
IgG Subclass 4
Preferred Specimen(s) Transport Temperature
Methodology
Clinical Significance
5428
1 mL serum
Refrigerated (cold packs)
Nephelometry
Overnight fasting is preferred
Inflammatory Bowel Disease Differentiation Panel
16503
Preferred Specimen(s)
2 mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
MethodologyImmunoassay
Reference Range(s)
230
ANCA Screen
Negative
P-ANCA Titer
<1:20
C-ANCA Titer
<1:20
Atypical P-ANCA Titer
<1:20
Myeloperoxidase Ab (MPO)
<6 U/mL
Negative
6-9 U/mL
Equivocal
>9 U/mL
Positive
<6 U/mL
Negative
6-9 U/mL
Equivocal
>9 U/mL
Positive
<20 U
Negative
20.1-29.9 U
Equivocal
>30 U
Positive
<20 U
Negative
20.1-29.9 U
Equivocal
>25 U
Positive
Proteinase-3 Ab (PR3)
Saccharomyces cerevisiae (IgG)
Saccharomyces cerevisiae (IgA)
IGF Binding Protein-3 (IGFBP-3)
Preferred Specimen(s)
Transport Temperature Reject Criteria Methodology Clinical Significance
34458
1 mL serum
Room temperature
Gross hemolysis • Gross lipemia • Plasma • Specimens out of stability
Immunoassay (IA)
Insulin-like growth factor binding proteins bind IGF-I and IGF-II with high affinity but do not bind insulin. Of the six distinct IGF binding proteins structurally characterized at this time, IGFBP-3 has been shown to be the major carrier of the IGFs, transporting approximately 95% of circulating IGF-I and IGF-II.
IGFBP-3 is growth hormone (GH) responsive. Thus, levels are high in cromegaly and low in hypopituitarism, and levels increase in GH-deficient children after GH administration. Thus, both assays and the ratios of IGF-I/IGFBP-2 and IGFBP-2/IGFBP-3 are useful as markers of GH action and for discriminating between growth hormone deficiency and short stature due to other etiologies in children. Other causes of short stature that result in reduced IGFBP-3 levels include poorly controlled diabetes.
The IGFBP-3 assay is useful in assessing nutritional status, since IGFBP-3 decreases during both caloric and protein restriction.
Insulin like Growth Factor I (IGF-I)
16293
Preferred Specimen(s)
1mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Gross hemolysis • Gross Lipemia • Received room temperature • Frozen glass tubes • Slightly, moderate, and grossly icteric specimens
MethodologyElectrochemiluminescence
Reference Range(s)
See Laboratory Report
Ion Mobility Lipoprotein Fraction
Patient Preparation
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
16129
Fasting preferred
4.5 mL serum
Note: Lab needs 3 tubes totaling 4.5 mL.
Plastic screw-cap vial (x3)
Refrigerated (cold packs)
Gross hemolysis • Gross lipemia
Colorimetric, Calculated, Ion Mobility, Immunoturbidimetry, Enzymatic
231
I
J
KRAS Mutation Analysis
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Reference Range(s)
16510
Formalin fixed, paraffin embedded tissue block
For submission of paraffin block, tissue source, and block ID are required on the test requisition
Formalin-fixed, paraffin embedded tissue block
Room temperature
Gross hemolysis • Clotted whole blood or bone marrow • Frozen whole blood or bone marrow
Polymerase Chain Reaction (PCR) • Sequencing
Negative
Lactic Acid, Plasma
585
Patient Preparation
Sample should be collected without the use of a tourniquet, avoid hand-clenching. If a tourniquet has been used, it should be released for one minute prior to drawing blood. Collected blood should be cooled on ice immediately and separated from the cells within 3 hours.
Preferred Specimen(s)
2mL frozen plasma from a gray-top tube
Instructions
The collected blood should be well-mixed and separated from the cells within 3 hours
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Gross hemolysis • Specimens with visible icterus
Methodology
Spectrophotometry (SP)
Reference Range(s)
4-16 mg/dL
Lead, Blood K
L
599
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Whole blood in certified low-lead collection tube:
• 3 mL venous whole blood in an EDTA (tan-top) tube or equivalent
• 0.5 mL capillary whole blood in a capillary collection EDTA (lavender-top) tube or equivalent
Note: 1. Not all EDTA collection tubes are certified as low lead content.
2. Submit separate collection tube if ordering another test, such as CBC.
Blood collection tube
Room temperature
Serum • Plasma • Glass capillary, yellow-top, red-top, gray-top oxalate, and (light blue-top) citrate tubes • Clotted, viscous specimens
Atomic Spectroscopy (AS)
Reference Range(s)
Birth-6 Years
<5 ug/dL
>6 Years
<10 ug/dL
Blood lead levels in the range of 5-9 ug/dL have been associated with adverse health effects in
children aged 6 years and younger. For this age group, case management varies by CDC Blood
Level range. Refer to current guidelines for recommended interventions.
CDC ranges (ug/dL)
<10
10-14
15-19
20-44
45-69
>69
Leptin
Preferred Specimen(s)
Transport Temperature
Methodology
Clinical Significance
232
90367
1 mL Serum
Serum: Refrigerated preferred;
Electrochemiluminescence (ECL)
Leptin is an adipocyte-derived hormone that is essential for normal body weight regulation. Leptin production is under neuroendocrine control so that serum concentrations vary directly with the amount of triglycerides stored in adipose tissue depots.
Levetiracetam (1514)
Preferred Specimen(s)
Alternative Specimen(s)
Transport Temperature
Methodology
Clinical Significance
1mL serum collected in a red-top tube (no gel)
Plasma collected in an EDTA (lavender-top), EDTA (royal blue-top) or sodium heparin (green-top) tube
Room temperature
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
Levetiracetam is an anticonvulsant used as adjunct therapy to treat adult partial seizures. As multiple anticonvulsants are administered, it is important to monitor its level to (1) optimize therapy, (2) assure compliance, and (3) to avoid toxicity.
Lithium, Serum Patient Preparation
Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Reference Range(s)
15142
613
Collect just prior to next dose
2 mL serum
Serum Separator Tube (SST‰)
Room temperature
Plasma from lithium-based anticoagulants • EDTA plasma
Atomic Absorption Spectrometry (AAS) • Ion Selective Electrode (ISE)
0.5-1.3 mEq/L
Maternal Serum Screen 5 (Penta Screen)
15934
Preferred Specimen(s)
4 mL serum
Instructions
For manual orders use ”Maternal Serum Screen Requisition”.
The Penta Screen test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15.0-16.9 weeks. This time frame allows sufficient opportunity for further diagnostic studies if the initial penta screen test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open Neural Tube Defects, Down Syndrome or Trisomy 18. The “Maternal Serum Screen Requisition”; designed to obtain patient data and the patient’s informed consent must be utilized when ordering the Penta Screen test. Because the Penta Screen test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of results: Date of collection, patient’s (maternal) date of birth, patient’s estimated date of delivery, patient’s weight, patient’s race, patient’s diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.
Transport Container
Plastic screw-cap vial
Transport Temperature
Refrigerated (cold packs)
Reject Criteria
Gross hemolysis • Lipemia • Received room temperature
MethodologyImmunoassay
Limitations
Maternal age confirmation and number of fetuses may alter result interpretation. Maternal screening tests consistent with increased risk of trisomy should be confirmed with CVS or amniotic fluid specimen. Maternal serum screening yields a low percentage of false negatives.
A wide range of other chromosomal abnormalities are not identified by maternal serum screening.
Metanephrines, Fractionated, LC/MS/MS, 24-Hour Urine
14962
Patient Preparation
It is preferable for the patient to be off medications for three days prior to collection. Patient should avoid tobacco, tea, coffee, for three days prior to specimen collection. Common antihypertensives (diuretics, ACE inhibitors, calcium channel blockers, alpha and beta blockers) cause minimal or no interference. Medications which are alpha agonists (Aldomet), alpha blockers (Dibenzyline) should be avoided 18-24 hours prior to specimen collection.
Preferred Specimen(s) 5 mL 24-hour urine sollected with 25 mL 6N HCL to maintain a pH <3
Alternative Specimen(s) No preservative
Transport Temperature Room temperature
Methodology Liquid Chromatomagraphy Tandem Mass Spectrometry (LC/MS/MS)
Clinical Significance
Useful in the evaluation of Pheochromocytoma.
233
M
N
Metanephrines, Fractionated, Free, LCMSMS, Plasma
19548
Methodology
Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
Limitations
False-positive results have been observed in patients with either chronic kidney disease or hypertension.
Clinical Significance
Normetanephrine (NM) and metanephrine (MN) are the extra-neuronal catechol-o-methyl transferase (COMT) metabolites of the catecholamines norepinephrine and epinephrine, respectively. Measurement of plasma metanephrines is more sensitive (but may be less specific) than measurement of catecholamines for the detection of pheochromocytoma. Proper interpretation of results requires awareness of recent medication/drug history (e.g., antyhypertensive agents, alcohol, cocaine) and other pre-analytical factors (e.g., stress, severe congestive heart failure, myocardial infarction) that influence release of catecholamines and metanephrines.
Mitochondrial Antibody with Reflex to Titer
259
Preferred Specimen(s)
0.5mL serum
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis • Gross lipemia
MethodologyImmunoassay
Reference Range(s)
Negative
Oligoclonal Bands, CSF
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
O
P
Protein C Antigen
674
1mL CSF submitted in a sterile, plastic, leak-proof container and 1mL serum
It is preferred that the collection date and time be the same for both CSF and serum; however, it is acceptable for them to be drawn within 48 hours of each other. Client must be contacted when no serum is supplied to confirm the order. It is acceptable to send through CSF without
serum when client has indicated to “run with serum control”. CSF must be crystalline and clear. (CSF collection tube #4 preferred).
Plastic screw-cap vial
Refrigerated (cold packs)
Received room temperature
Isoelectric Focusing
4948
Preferred Specimen(s)
1 mL frozen plasma collected in 3.2% sodium citrate (light blue-top) tube
Instructions
Draw blood in light blue-top tube containing 3.2% sodium citrate. Mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500 g within 1 hour of collection. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic vial.
Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and ship on dry ice.
*Note: 3.8% sodium citrate (light blue-top) tube is unacceptable.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received room temperature • Received refrigerated
MethodologyImmunoassay
Reference Range(s)
70-140% normal
Protein S Antigen
5165
Preferred Specimen(s)
1 mL frozen plasma collected in a 3.2% sodium citrate (light blue-top) tube
Instructions
Draw blood in 3.2 % sodium citrate (light blue-top) tube. Mix gently by inverting 3-4 times. Centrifuge 15 minutes at 1500g within 1 hour of collection. Using a plastic pipette, remove plasma, taking care to avoid the WBC/platelet (buffy) layer and place into a plastic vial. Centrifuge a second time and transfer platelet-poor plasma into a new plastic vial. Freeze immediately and ship on dry ice.
Note: 3.8% sodium citrate (light blue-top) tube is unacceptable
234
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Received room temperature • Received room temperature • Received thawed
Methodology
Micro Latex Particle Mediated Immunoassay
Reference Range(s)
70-140 % normal
Prothrombin (Factor II) 20210GA Mutation Analysis Preferred Specimen(s)
Transport Container
Transport Temperature
Reject Criteria
Methodology
Limitations
5mL whole blood collected in an EDTA (lavender-top) tube
EDTA (lavender-top)
Room temperature
Received frozen
Polymerase Chain Reaction (PCR) • Oligonucleotide Ligation Assay • Fluorescent Microspheres
If this mutation is not found by the testing procedure, it does not mean that the risk of carrying or developing deep vein thrombosis is not present. It simply means that this specific mutation has not been found, although other mutations may be present. It is also possible that such a
patient may have secondary deep vein thrombosis due to non-genetic causes that would not be detected by this test. A person with one copy of the mutation has an approximate 3-fold increase in risk for venous thrombosis. The increase in risk for a person with two copies of the
mutation is not known.
Testosterone, Free and Total, LC/MS/MS Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
36170
0.9 mL serum collected in a red-top tube (no gel)
Specify age and sex on test requisition
Plastic screw-cap vial
Refrigerated (cold packs)
Serum Separator Tube (SST‰)
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) • Tracer Equilibrium Dialysis • Calculation
Testosterone, Free, Bioavailable and Total, LC/MS/MS
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Reject Criteria
Methodology
Reference Range(s)
17909
14966
2.8 mL serum collected in a red-top tube (no gel)
Serum Separator Tubes (SST‰s) are not acceptable
Plastic screw-cap vial
Room Temperature
Serum Separator Tube (SST‰)
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS) • Calculation • Spectrophotometry (SP) • Immunochemiluminescent Assay
See Laboratory Report
Thiopurine S-Methyltransferase (TPMT) Genotype
37742
Preferred Specimen(s)
5 mL whole blood collected in an EDTA (lavender-top) tube
Instructions
Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
Transport Container
EDTA (lavender-top) tube
Transport Temperature
Room temperature
Reject Criteria
Received frozen • Wrong specimen type • Exceeds stability • Less than minimum volume received
Methodology
Polymerase Chain Reaction (PCR) • Single Nucleotide Primer Extension
Limitations
This test detects 95% of the mutations in the TPMT gene and thus not all intermediate or slow metabolizers will be identified.
Reference Range(s)
See Laboratory Report
Vanillymandelic Acid (VMA), 24-Hour Urine
Patient Preparation
39517
It is preferable for the patient to be off medications for three days prior to collection. However, common antihypertensives (diuretics, ACE inhibitors, calcium channel blockers, alpha and beta blockers) cause minimal or no interference. Patient should avoid alcohol, coffee, tea,
235
S
T
Preferred Specimen(s)
Transport Container
Transport Temperature
Methodology
Limitations
tobacco (including use of nicotine patch), bananas, citrus fruits and strenuous exercise prior to collection.
10 mL of a 24-hour urine collected with 25 mL 6N HCl to maintain a pH below 3 during collection. Urine without preservative is acceptable if pH is below 6 and the sample is
shipped frozen.
Plastic urine container
Room temperature
High Performance Liquid Chromatography (HPLC) • Electrochemical Detection
Requires accurate 24-hour urine collection.
Reference Range(s)
VMA
Creatinine, Urine
3-8 Years
<2.3 mg/24 h
9-12 Years
<3.4 mg/24 h
13-17 Years
<3.9 mg/24 h
Adults
<6.0 mg/24 h
3-8 Years
0.11-0.68 g/24 h
9-12 Years
0.17-1.41 g/24 h
13-17 Years
0.29-1.87 g/24 h
Adults
0.63-2.50 g/24 h
Varicella-Zoster Virus Antibody (IgG)
4439
Preferred Specimen(s)
1 mL serum
Instructions
Avoid hemolysis by prompt separation of the serum from the clot
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis • Gross lipemia • Plasma • Grossly icteric
MethodologyImmunoassay
Limitations
Other herpes viruses may cross react and produce high titers. Protection may be limited at low positive titers. Antibodies persist after infection has been treated or becomes dormant.
Reference Range(s)
<0.90
Negative - No VZV IgG Antibody detected
0.91-1.09
Equivocal
>1.10
Positive - VZV IgG Antibody detected
Vitamin B6 (Pyridoxine)
U
V
926
Patient Preparation
Overnight fasting. Patient must be restricted from alcohol and vitamins for at least 24 hours before a sample collection.
Preferred Specimen(s)
1 mL frozen plasma collected in an EDTA (lavender-top) tube - protected from light
Instructions
Draw blood into a protected from light lavender-top evacuated tube.
If separation of cells can’t be performed immediately after collection, keep the whole blood refrigerated and protect from light. The separation of cells must be completed within 6 hours. Separate cells by centrifugation at 2-8° C (2200-2500 rpm, 800-1000 g) for 5-10 minutes. Transfer plasma to dark brown polypropylene or polyethylene transport tubes to protect from light. Alternately, neutral color polypropylene or polyethylene tubes can be used if wrapped in aluminum foil. Freeze the tubes at -10 to -30° C. Ship frozen.
Transport Container
Plastic screw-cap vial
Transport TemperatureFrozen
Reject Criteria
Hemolysis • Lipemia • Received room temperature • Received refrigerated • Received thawed • Plasma collected in EDTA (royal blue-top), sodium heparin (green-top) or lithium heparin (green-top) tube • Specimens not protected from light
Methodology
Liquid Chromatography, Tandem Mass Spectrometry (LC/MS/MS)
Reference Range(s)
236
2-17 years
3.0-35.0 ng/mL
Adult
2.1-21.7 ng/mL
Vitamin D, 1,25-Dihydroxy, LC/MS/MS 16558
Preferred Specimen(s)
Instructions
Transport Container
Transport Temperature
Methodology
2 mL serum
Collect blood in a Vacutainer‰. Allow blood to clot (30 minutes) at room temperature, 18-25°C. Centrifuge and separate the serum from the cells.
If sample is submitted with less than 1.1 mL and needs to be repeated the sample will be canceled with the comment “TNP-Initial testing necessitated a repeat, but there was insufficient sample to perform repeat”.
Plastic screw-cap vial
Room temperature
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Reference Range(s)
Vitamin D, 1,25 (OH)2, Total
Vitamin D3, 1,25 (OH)2
1-9 Years
31-87 pg/mL
10-13 Years
30-83 pg/mL
14-17 Years
19-83 pg/mL
Adult
18-72 pg/mL
Not available
Vitamin D2, 1,25 (OH)2
Vitamin D, 25-Hydroxy, LC/MS/MS
17306
Patient Preparation
Fasting preferred, but not required
Preferred Specimen(s)
0.3 mL serum
Instructions
Collect blood in a standard red-top serum Vacutainer‰ tube. Allow blood to clot at room temperature. Centrifuge and separate the serum from the cells immediately. Alternatively, collect blood in an SST‰, allow to clot at room temperature, centrifuge and remove from the gel within 48 hours.
Transport Container
Plastic screw-cap vial
Transport Temperature
Room temperature
Reject Criteria
Gross hemolysis • Gross lipemia • Heparinized or EDTA plasma • Serum not separated from SST‰ gel or clot within 48 hours
Methodology
Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
Reference Range(s)
Vitamin D, 25-OH, Total
30-100 ng/mL
25-OHD3 indicates both endogenous production and
supplementation. 25-OHD2 is an indicator of exogenous
sources such as diet or supplementation. Therapy is based
on measurement of Total 25-OHD, with levels <20 ng/mL
indicative of Vitamin D deficiency, while levels between 20
ng/mL and 30 ng/mL suggest insufficiency. Optimal levels
are ≥30 ng/mL.
Vitamin D, 25-OH, D3
Reference range not established
Vitamin D, 25-OH, D2
Reference range not established
U
V
237
238
Index by Test Name
239
240
Index for Gurgaon lab
Gurgaon laboratory
Code Page
ABL Kinase Domain Mutation in 16031 65
CML, Plasma-Based, LeumetaTM ABO Group and Rh Type (Blood Grouping) 7788
65
Acid Fast Stain - Flurochrome Method 4503
65
Acid Fast Stain - Kinyoun Method 14511
65
Acid Fast Stain, modified Stool 14512
66
Activated Protein C-Resistance 22
66
Acid Fast Stain-Ziehl Neelsen Method 78649 66
ADA (Adenosine Deaminase)
79114
66
Alanine Amino Transferase (ALT)/(SGPT) 823
67
Albumin 223
67
Alcohol, Ethyl Qualitative, Urine (Ethanol) 78094 67
Alkaline Phosphatase 234 68
Alpha-1- Antitrypsin 235 68
Alpha-1 Antitrypsin (AAT) Mutation Analysis, 15340 68
Genotype
Alpha-Fetoprotein, Tumor Marker 237
68
AML1-ETO t(8;21) RT PCR 79560 69
Amphetamine Urine 78080 69
Amylase serum 243 69
Anemia Extended Profile (CBC, Reticulocyte 78664 69
Count, Folate Serum, Vitamin B12, Iron Total and Total Iron Binding Capacity)
Antifungal Susceptibility Panel 79030 70
Antinuclear Antibody Screen (ANA), IFA 79005 70
Anti Thyriod proxidase (Anti-TPO) 5081 70
Anti Thyroglobulin Panel 7260 70
Androstenedione 78110 71
Anemia Panel 1 78531 71
Anemia Panel 2 78532 71
Anemia Panel 3 78534 71
Angiotensin-1-Converting Enzyme 683 71
Antenatal Panel - I 19909 72
Antenatal Panel - II 78530 72
Antibody to PM-Scl 37103 72
Anti-Phospholipid Syndrome Panel 3 78525 73
Anti-Streptolysin O Antibody (ASO) 265 73
Antithrombin III Activity 216 73
Antithrombin III, Antigen 5158 73
Antinuclear Antibody Screen (ANA), ELISA 79004 74
Anti-Neutrophil Cytoplasmic Antibody By IFA 79006 74
Apolipoprotein A1 78092 74
Apolipoprotein B 78093 74
Arthritis Panel 1 78515 75
Aspartate Amino Transferase (AST)/(SGOT) 822 75
Barbiturates, Urine 78081 75
Basic Fever Panel 78584 75
BCR/ABL FISH Assay 14641
76
Beta-2-Microglobulin, Serum 852 76
Benzodiazepine, Urine 78082 76
Bilirubin, Direct 285
77
Gurgaon laboratory
Code Page
Bilirubin, Fractionated 7286 77
Bilirubin, Total 287 77
BOH (Bad Obstetrics History) Panel 78910 78
Bone Marrow Biopsy with Reticulin Stain 79199 78
Bone Marrow Examination 78685 78
B-Type Natriuretic Peptide (BNP) 37386 78
CA 15-3, serum 5819 79
CA 19-9, serum 4698 79
CA 125, Serum 29256 79
Calcium Random Urine 79838 79
Calcium, Serum 303 80
Calcium, 24-Hour Urine 1635 80
Culture, Fungus, Blood ,Rapid 79886 80
Campath®-1H Sensitivity (CD52) 10980 80
Carbon Dioxide, Serum 310 81
Cardio CRP (hsCRP) 10124 81
Cardiolipin IgA Ab 4661 81
Cardiolipin IgG Ab 4662 81
Cardiolipin IgM Ab 4663 81
Cardiolipin Antibody Panel (IgA, IgG, IgM) 36189 82
CBFB beta/MYH11 inv(16) RT PCR, CELLS 14992 82
CBFB/MYH11, Inversion 16 FISH Assay 14642 82
Carcinoembryonic Antigen (CEA) 978 83
Ceruloplasmin 326 83
Celiac Disease Panel 15980 83
Chikungunya Fever, Igm 19915 83
Chikungunya Fever, IgG 79093 83
Chloride 330 84
Chloride, 24-Hour Urine 368 84
Cholesterol, Total 334 84
Chromosome Analysis / Peripheral 14627 85
Blood Leukocyte Culture for Genetic Analysis (Karyotyping)
Chromosome Analysis, Hematologic, 14636 85
Malignancy
Chromosome Analysis, Mosaicism 14632 85
Cocaine Metabolites By GC/MS (Urine) 5530 86
Cocaine Urine 78083 86
Complement 3 (C3) 78050 86
Complement 4 (C4) 78051 86
Complete Blood Count (CBC) with 78511 87
Peripheral blood smear and ESR
Complete Blood Count (CBC) with 78512 87 Peripheral blood smear
Complete Blood Count (CBC) 6399 87
Cortisol – Total 367 87
Cortisol, A.M. 4212 88
Cortisol, P.M. 4213 88
Coombs Test - Indirect 795 88
C-Peptide 531 88
C-Reactive Protein (CRP) 4420 88
241
Gurgaon laboratory
Code Page
Gurgaon laboratory
Creatine Kinase (CK), Total Creatinine, Random Urine Creatinine with Glomerular Filtration Rate, Estimated (eGFR)
Creatinine, 24-Hour Urine Culture, Genital Culture, Genital (Charcoal Media) Culture Fungus other than Blood Culture, Aerobic Bacteria with Susceptibility Culture, Aerobic Blood Culture, Stool (Salmonella/Shigella/
Campylobacter)
Culture, Throat Culture, Urine, Routine Culture, Body Fluid Culture, Sputum Cyclic Citrullinated Peptide (CCP) Antibody IgG
Cysticercus Antibody IgG (Serum) Cytomegalovirus Antibodies (IgG, IgM) Cytomegalovirus Antibodies (IgG) Cytomegalovirus Antibodies (IgM) D-Dimer, Semi-Quantitative Dengue Fever Antibody (IgG) Dengue Fever Antibody (IgM) Dengue NS1 Antigen Dengue NS1 Antigen and Dengue Antibodies Panel (IgG & IgM)
Dengue NS1 Antigen And Dengue IgM Panel Dengue Fever Antibody (IgG, IgM) Dengue, Antibodies Rapid Detection DHEA Sulfate Diabetic Management Cardiac Panel Diabetes Management Panel Basic (Glucose F & HbA1c)
Diabetic Profile Dihydropyrimidine Dehydrogenase (DPD)
Gene Mutation Analysis
Direct Antiglobulin Test (DAT) Direct LDL DNA (ds) Antibodies Drug Panel 11 Drug Panel 9 Electrolyte Panel Entamoeba histolytica Antibody, IgG, EIA Entamoeba histolytica Antigen, EIA Erythrocyte Sedimentation Rate (ESR) Enhanced Estradiol (eE2) Eosinophil Count, Absolute Estriol, Unconjugated (uE3) 374 8459 375 89
89
89
381 4558 45559 4553 4550 389 10045 89
90
90
90
90
91
91
394 395 4473 4556 11173 91
92
92
92
92
79494 79533 79910 79912
79007 37579 37580 79555 78612 93
93
93
93
94
94
94
94
95
78611 34301 79019 402 78535 78559
95
95
95
95
96
96
78665 15538 96
96
361 8293 255 78623 78617 34392 30262 34964 79930 15577 425 434 97
97
97
97
98
98
98
98
99
99
99
99
Factor V Activity 79347 Factor V (Leiden) Mutation Analysis 17900 Factor V HR2 Allele DNA Mutation Analysis 17902 Factor VII 79113 Factor VIII Activity, Clotting 347 Factor X, Activity 79112 Factor XIII Activity 14461 Ferritin 457 Fibrinogen 461 Fibrinogen Degradation Product (FDP) 458 First Trimester Screening With NT Value 79223 First Trimester Screening Without NT Value 79221 FISH TEL/AML 1 assay 14644 FISH PML/RARA Assay 14643 FISH ETO/AML1 Assay 14640 FISH, EGFR 19041 FISH, HER-2/neu, Paraffin Block 14620 Flow Surface Light Chains, Flow Cytometry 11015 Flow ONTAK® Sensitivity (CD25) 11237 Flow NK Cells (CD3/CD45/CD16+
14798
CD 56/CD19)
Flow Lymphocte Subset CD3% 19913
(Flow Cytometry)
Flow Lymphocte Subset CD4% 14804
(Flow Cytometry)
Flow Lymphocte Subset CD8% 19914
(Flow Cytometry)
Fluid Analysis, Ascitic Fluid 78549 Fluid Analysis, Pericardial Fluid 78551 Fluid Analysis, Pleural Fluid 78552 Fluid Analysis, Synovial Fluid 78553 Free ß-hCG 79620 Folate, Serum 466 Follicular Lymphoma, bcl-2/JH t(14;18),
17690
Real-Time PCR, Plasma-Based
Fructosamine
8340 FSH (Follicle Stimulating Hormone) 470 Fungus, Direct Examination, Skin, Hair or Nails 14824 Gamma Glutamyl Transferase (GGT) 482 Genotype MTbDR Panel 79554 Gliadin Antibody (IgA) 11228 Gliadin Antibody (IgG) 11212 Glucose 483 Glucose, Random (Plasma) 8917 Glucose Tolerance Test, 3 serum
23475
specimens (75g)
Glucose, Fasting & Post Prandial 6881 Glucose, Fasting (Plasma) 484 Glucose 6 Phosphate Dehydrogenase 78024
(G-6-PD) Activity Blood (Quantitative)
Glucose Tolerance Test, Gestational, 6745
4 Specimens (100mg)
242
Code Page
99
100
100
100
100
101
101
101
101
101
102
102
102
102
103
103
103
104
104
104
104
105
105
105
105
105
106
106
106
107
107
107
107
108
108
108
108
109
109
109
110
110
110
110
Gurgaon laboratory
Code Page
Glucose, Gestational Screen (50g) 8477 110
Glucose, Postprandial 78005 111
Gram Stain 497 111
Growth Hormone 521 111
Haptoglobin 502 111
Haemoglobin and Hematocrit Panel 7998 111
Hb Electrophoresis by Capillarys 78942 112
hCG, Qualitative, Urine 396 112
hCG, Total, Quantitative 8396 112
HDL Cholesterol 608 112
Hemoglobin A1c 496 113
Hemoglobin 510 113
Hepatic Function Panel 10256 113
Hepatic Function Panel 2 78570 113
Hepatitis A Antibody, Total 508 113
Hepatitis A IgM Antibody 512 113
Hepatitis B Core Antibody Total 37676 114
Hepatitis B Virus Surface Antigen, CLIA 37567 114
Hepatitis Be Antibody 556 114
Hepatitis Be Antigen and Antibodies serum 78558 114
Hepatitis B Core IgM Antibody 4848 115
Hepatitis B Surface Antibody, Qualitative 499 115
Hepatitis B Surface Antibody, Quantitative 8475 115
Hepatitis B Viral DNA, Quantitative, PCR 8369 115
Hepatitis Be Antigen 555 115
Hepatitis C Antibody 8472 116
Hepatitis C Virus RNA, Quantitative, 35645 116
Real-Time PCR
Hepatitis E Antibody (IgG) 36583 116
Hepatitis E Antibody (IgM) 36582 116
Hepatitis B Viral DNA, Qualitative, RT-PCR 78018 116
Hepatitis C Virus RNA, Qualitative PCR 34024 117
Herpes Simplex Virus 1 IgG, Type Specific 79488 117
Antibody
Herpes Simplex Virus 2 IgG, Type Specific 79489 117
Antibody
Herpes Simplex Virus 1 & 2, IgG 6447 117
Herpes Simplex Virus 1 & 2, IgG and IgM 10014 118
Herpes Simplex Virus 1 & 2, IgM 17369 118
Herpes Simplex Virus 1, IgG and IgM 78547 118
Herpes Simplex Virus 1, IgM 79490 119
Herpes Simplex Virus 2, IgG and IgM 78548 119
Herpes Simplex Virus 2, IgM 79491 119
HIV Prognosticator Panel HIV Quantitative, 78540 120
CD3, CD4, and CD8 Absolute and Percentage counts
HIV-1 and 2 Antibody 19923 120
HIV-1 Antibody Confirmation by Western Blot 79003 120
HIV-1 RNA, Quantitative, PCR, 14484 120
Expanded Range
HIV-1 RNA, Qualitative, RT-PCR 37815 121
Gurgaon laboratory
Code Page
HLA B27 DNA Typing PCR Homocysteine, Cardiovascular Homocysteine, Nutritional and Congenital HPV DNA, High Risk (cervista) HPV Genotypes 16 & 18 (Cervista) IGF BINDING PROTEIN-1 IHC-AE1/AE3 With Interpretation IHC-AE1/AE3 Without Interpretation IHC-AFP With Interpretation IHC-AFP Without Interpretation IHC-ANNEXIN A1 with Interpretation IHC-ANNEXIN A1 without Interpretation IHC-BCL2 With Interpretation IHC-BCL2 Without Interpretation IHC-BCL6 With Interpretation IHC-BCL6 Without Interpretation IHC-BER-EP4 with Interpretation IHC-BER-EP4 without Interpretation IHC-BRCA1 with Interpretation IHC-BRCA1 without Interpretation IHC-BRCA2 with Interpretation IHC-BRCA2 without Interpretation IHC-34 Beta E12 With Interpretation IHC-34 Beta E12 Without Interpretation IHC-CA19.9 With Interpretation IHC-CA19.9 Without Interpretation IHC-CA125 with Interpretation IHC-CA125 without Interpretation IHC-Calretinin With Interpretation IHC-Calretinin Without Interpretation IHC-CD2 with Interpretation IHC-CD2 without Interpretation IHC-CD3 with Interpretation IHC-CD3 without Interpretation IHC-CD4 with Interpretation IHC-CD4 without Interpretation IHC-CD 5 With Interpretation IHC-CD 5 Without Interpretation IHC-CD7 with Interpretation IHC-CD7 without Interpretation IHC-CD8 with Interpretation IHC-CD8 without Interpretation IHC-CD10 with interpretation IHC-CD10 without interpretation IHC-CD15 With Interpretation IHC-CD15 without Interpretation IHC-CD20 with Interpretation IHC-CD20 without Interpretation IHC-CD21 with Interpretation IHC-CD21 without Interpretation IHC-CD23 with Interpretation 15584 31789 36362 79557 79558 36590 78700 78701 78821 78812 78773 78774 78759 78760 78761 78762 78789 78790 78841 78842 78798 78799 78736 78737 78830 78831 78874 78875 78708 78709 78845 78846 78702 78703 78839 78840 78748 78749 78765 78766 78813 78814 78742 78743 78847 78848 78726 78729 78767 78768 78817 121
121
121
122
122
123
123
123
123
124
124
124
124
125
125
125
125
126
126
126
126
127
127
127
127
127
128
128
128
128
129
129
129
129
130
130
130
130
131
131
131
131
131
132
132
132
132
133
133
133
133
243
Gurgaon laboratory
Code Page
Gurgaon laboratory
IHC-CD23 without Interpretation IHC-CD 30 With Interpretation IHC-CD 30 Without Interpretation IHC-CD31 with Interpretation IHC-CD31 without Interpretation IHC-CD34 with Interpretation IHC-CD34 without Interpretation IHC-CD43 with Interpretation IHC-CD43 without Interpretation IHC-CD 45 With Interpretation IHC-CD 45 Without Interpretation IHC-CD56 with Interpretation IHC-CD56 without Interpretation IHC-CD61 with Interpretation IHC-CD61 without Interpretation IHC-CD68 with Interpretation IHC-CD 68 without Interpretation IHC-CD79a with Interpretation IHC-CD79a without Interpretation IHC-CD99 with Interpretation IHC-CD99 without Interpretation IHC-CDX 2 with Interpretation IHC-CDX 2 without Interpretation IHC-CD 138 With Interpretation IHC-CD138 without interpretation IHC-Chromogranin A with Interpretation IHC-Chromogranin A without Interpretation IHC-CK5/6 with Interpretation IHC-CK5/6 without Interpretation IHC-CK7 with Interpretation IHC-CK7 without Interpretation IHC-CK8 with Interpretation IHC-CK8 without Interpretation IHC-CK18 (LMW) with Interpretation IHC-CK18 (LMW) without Interpretation IHC-CK20 with Interpretation IHC-CK20 without Interpretation IHC-CKIT (CD117) with Interpretation IHC-CKIT (CD117) without Interpretation IHC-Collagen IV with Interpretation IHC-Collagen IV without Interpretation IHC-Cyclin D1 with Interpretation IHC-Cyclin D1 Without Interpretation IHC-Cytoplasmic IgA with Interpretation IHC-Cytoplasmic IgA without Interpretation IHC-Cytoplasmic IgG with Interpretation IHC-Cytoplasmic IgG without Interpretation IHC-Cytoplasmic IgM with Interpretation IHC-Cytoplasmic IgM without Interpretation IHC-DBA44 with Interpretation IHC-DBA44 without Interpretation 78818 78758 78780 78793 78794 78769 78770 78785 78786 78746 78747 78783 78784 78857 78858 78797 78832 78836 78833 78781 78782 78727 78728 78750 78751 78730 78731 78802 78803 78706 78707 78808 78809 78868 78869 78704 78705 78815 78816 78881 78882 78837 78838 78853 78854 78824 78825 78879 78880 78883 78884 IHC-Desmin with Interpretation 78740 IHC-Desmin without Interpretation 78741 IHC-EBV with Interpretation 78834 IHC-EBV without Interpretation 78835 IHC-E Cadherin with Interpretation 78826 IHC-E Cadherin without Interpretation 78827 IHC-EGFR with Interpretation 78719 IHC-EGFR without Interpretation 78720 IHC-EMA with Interpretation 78763 IHC-EMA without Interpretation 78764 IHC-ER/PgR/DNA, Paraffin Block 39479 IHC-ER/PgR with Interpretation 10736
IHC-ER/PgR without Interpretation
79495 IHC-ER/PgR/HER-2/neu with Interpretation 78927 IHC-ER/PgR/HER-2/neu without Interpretation79496 IHC-GFAP with Interpretation 78876 IHC-GFAP without Interpretation 78877 IHC-HEP PAR-1 with Interpretation 78778 IHC-HEP PAR-1 without Interpretation 78811 IHC-Her2 neu 79021 IHC-HER-2/neu with Interpretation
79021 IHC-HER-2/neu without Interpretation
79497 IHC-HLA DR with Interpretation 78885 IHC-HLA DR without Interpretation 78878 IHC-HMB 45 with Interpretation
78754 IHC-HMB 45 without Interpretation 78755 IHC-IgD with Interpretation 78843 IHC-IgD without Interpretation 78844 IHC-INHIBIN with Interpretation 78864 IHC-INHIBIN without Interpretation 78865 IHC-KAPPA Light Chains with Interpretation 78806 IHC-KAPPA Light Chains without Interpretation 78807 IHC-Ki 67 with Interpretation 78721 IHC-Ki 67 without Interpretation 78722 IHC-LAMBDA Light Chain with Interpretation 78775 IHC-LAMBDA Light Chain without 78776 Interpretation
IHC-MELAN A with Interpretation 78744 IHC-MELAN A without Interpretation 78745 IHC-MLH-1 with Interpretation 78859 IHC-MLH-1 without Interpretation 78860 IHC-MPO with Interpretation 78855 IHC-MPO without Interpretation 78856 IHC-MSH-2 with Interpretation 78872 IHC-MSH-2 without Interpretation 78873 IHC-MUM1 with Interpretation 78787 IHC-MUM1 without Interpretation 78788 IHC-MYO D1 with Interpretation 78752 IHC-MYO D1 without Interpretation 78753 IHC-MYOGENIN with Interpretation 78771 IHC-MYOGENIN without Interpretation 78772 244
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Code Page
145
146
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156
156
156
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157
157
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158
158
Gurgaon laboratory
Code Page
Gurgaon laboratory
Code Page
IHC-NSE with Interpretation IHC-NSE without Interpretation IHC-P504S (AMACR) with Interpretation IHC-P504S (AMACR) without Interpretation IHC-P53 with Interpretation IHC-P53 without Interpretation IHC-PAX 5 (BSAP) with Interpretation IHC-PAX 5 (BSAP) without Interpretation IHC-P-CEA with Interpretation IHC-P-CEA without Interpretation IHC-PLAP with Interpretation IHC-PLAP without Interpretation IHC-PSA with Interpretation IHC-PSA without Interpretation IHC-PTEN with Interpretation IHC-PTEN without Interpretation IHC-S100 with Interpretatation IHC-S100 without Interpretatation IHC-SMA with Interpretation IHC-SMA without Interpretation IHC-SYNAPTOPHYSIN with Interpretation IHC-SYNAPTOPHYSIN without Interpretation IHC-TDT with Interpretation IHC-TDT without Interpretation IHC-THYROGLOBIN with Interpretation IHC-THYROGLOBIN without Interpretation IHC-Thrombomodulin with Interpretation
IHC-Thrombomodulin without Interpretation
IHC-TTF-I with Interpretation IHC-TTF-I without Interpretation IHC-VIMENTIN with Interpretation IHC-VIMENTIN without Interpretation IHC-WT1 with Interpretation IHC-WT1 without Interpretation Immunoglobulin A (IgA), Serum Immunoglobulin E (IgE), Total, Serum - Serology
Immunoglobulin G (IgG), Serum Immunoglobulin M (IgM), Serum Infertility Panel 1, Male Influenza A H1N1 Real Time RT PCR Inhibin A Insulin Insulin Response to Glucose, 120 min Integrated Panel 1 Integrated Panel 2 Intrinsic Factor Blocking Antibody Iron, Total Iron, Total and Total Iron Binding Capacity Lactate Dehydrogenase (LD) LH (Leuteinizing Hormone) 78819 78820 78738 78739 78710 78711 78756 78757 78712 78713 78777 78810 78732 78733 78851 78852 78717 78718 78870 78871 78723 78716 78791 78792 78795 78861 78796 78862 78724 78725 78714 78715 78822 78823 539 542 158
159
159
159
159
159
160
160
160
160
161
161
161
161
162
162
162
162
163
163
163
163
163
164
164
164
164
165
165
165
165
165
166
166
166
166
543 545 78528 79702 34472 561 78043 79801 79802 568 571 7573 593 615 167
167
167
167
167
168
168
168
168
168
168
169
169
169
LH, FSH, and PRL 78529 170
Lipase 606 170
Lipid Panel with calculated LDL 7600 170
Lipid-Associated Sialic Acid (LSA,LASA) 8343 170
Lipoprotein (a) 34604 170
Liver Kidney Microsomal (LKM-1) 15038 171
Antibody (IgG)
Magnesium 622 171
Malaria and Blood Parasites 831 171
Malarial antigen detection 79022 171
Marijuana Metabolites, GC/MS, Urine 4846 172
Marijuana Metabolite (50) 78084 172
(Cannabinoids / THC)
Methaqualone, Urine 78086 172
Maternal Serum Screen 1 (AFP), 78321 172
Second Trimester
Maternal Serum Screen 3 by using 7292 173
Prisca Software
Maternal Serum Screen 3 by using 78322 173
Maciel Software
Maternal Serum Screen 4 (Quad Screen by 78324 174
using Maciel Software)
Methadone, Urine 78085 174
Metanephrines, Fractionated, Plasma 15920 174
Microalbuminuria, 24Hrs urine 78576 175
Microalbumin, Random Urine with Creatinine 6517 175
Microfilaria Detection 10060 175
Micrometastasis Detection in Lymph Nodes 12740 175
Mumps Antibody Panel (IgG, IgM) 36564 176
Mycobacterium Tuberculosis 1st line drug 79552 176
(RIF/INH) Sensitivity assay by Hains (Rapid)
Mycobacterium Tuberculosis 2nd line drug 79553 176
(Ofloxacin, Levoflxacin, Moxifloxacin, ciprofloxacin, Amikacin, Kanamycin & Capreomycin) sensitivity by Hains (Rapid)
Mycobacterium tuberculosis Complex, PCR, 30277 176
Non-Respiratory
Mycobacterium tuberculosis Complex, PCR, 30298 177
Respiratory
Mycobacterium tuberculosis Drug Sensitivity 78545 177
(5 Drugs)
Mycobacterium tuberculosis Drug Sensitivity 79524 177
(8 Drugs)
Mycobacterium, Blood Culture
10526 177
Mycobacterium, Culture 4554 178
Mycobacterium Tuberculosis RT-PCR 79277 178
Neisseria gonorrhoeae (GC), Culture 480 179
Neisseria gonorrhoeae Smear 79025 179
Neuron Specific Enolase (NSE) 34476 179
Non-Gynaecologic Cytology 10676 179
Nuclear Matrix Proteins (NMP-22®) 34099 180
245
Gurgaon laboratory
Code Page
Occult Blood Stool 79033 Opiates, Clinical Screen with Confirmation 30470 Opiates, Urine 78087 Ovarian Dysfunction Assessment Panel 78539 OVA-1
79841 Pap 1 Slide (Pap conventional) 3526 Pap Test By Liquid Based Cytology (LBC) 35455 Pap Test By LBC Without Interpretation 35456 Pap Test By Liquid Based Cytology & High Risk 78990 HPV DNA
Partial Thromboplastin Time, Activated (aPTT) 763 Periodic Acid Schiff (PAS) Stain 70012 Peripheral Blood Smear 833 Phenytoin 79072 Phosphate 718 Phosphate, 24-Hour Urine 719 Phospholipid Antibodies Panel 79050 Phospholipid Antibody IgA 79049 Phospholipid Antibody IgG 79047 Phospholipid Antibody IgM 79048 Phosphorus, Random Urine 14579 Plasminogen Activator Inhibitor (PAI-1) 36555 Platelet Count EDTA 723 Polycystic Ovarian Syndrome Panel 78544 Potassium, Serum 733 Potassium, Random Urine 14521 Prealbumin 4847 Pregnancy Associated Plasma Protein - A 79971 (PAPP-A)
proBNP, N-terminal 11188 Progesterone, LC/MS/MS 17183 Progesterone Serum 745 Prolactin 746 Propoxyphene, Urine 78089 Phencyclidine (PCP), Urine 78088 Protein C Activity 1777 Protein C Activity and Antigen 8757 Protein C Antigen 4948 Protein Electrophoresis, Serum (SPEP) 747 Protein S Activity 1779 Protein S Antigen 5165 Protein, Total 754 Protein, Total, CSF 755 Protein, Total, 24-Hour Urine with Creatinine 757 Protein, Total, Random Urine with Creatinine 1715 Prothrombin (Factor II) 20210G. A Mutation 17909 Analysis
Prothrombin Time with INR 8847 PSA Total 5363 PSA, Free and Total 31348 PTH, Intact and Calcium 8837 246
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188
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189
189
190
190
190
190
191
191
191
191
192
192
192
192
193
193
Gurgaon laboratory
Code Page
PTH-Related Protein (PTH-rP) Pyrexia of Unknown Origin (PUO) Panel Quantiferon GoldTB Renal Function Panel 1 Renal Function Panel 2 Reticulin Stain With Interpretation Reticulin Stain Without Interpretation Reticulocyte Count, Automated Rheumatoid Factor Rotavirus Antigen RPR for Syphilis Rubella Antibodies (IgG, IgM) Rubella Antibodies, IgG Rubella Antibodies (IgM) Saccharomyces (ASCA) IgA Saccharomyces (ASCA) IgG Screening Fever Panel Scl-70 Serotonin, Serum Serum Immunofixation Electophoresis Sex Hormone Binding Globulin (SHBG) Sickle Cell Anemia Mutation Analysis Sjogren’s Antibody (SS-A) / (Anti-Ro) Sjogren’s Antibody (SS-B) / (Anti-La) Slide Review (upto 2 slides/blocks)
Slide Review (more than 2 slides/blocks)
Slide for Issue (1 slide only)
SM/RNP antibodies Sodium Sodium, Random Urine Stool Ova and Parasites Stool Routine/Microscopic Streptococcus, Group A, Culture T3 Free (FT3) T3 Total T4, Free (FT4) T4 Total (Thyroxine) TA90 (Melanoma-Associated Antigen) Testosterone, Free, Bioavailable and Total, LC/MS/MS
Testosterone, Total Thrombophila Panel Thyroglobulin Antibodies (Atg) Thyroglobulin Panel Thyroglobulin (Tg) Thyroid Hormone Panel 2 Thyroid Hormone Panel 3 Tissue Biopsy, Small Tissue Biopsy, Medium Tissue Biopsy, Large
Tissue Biopsy (Complex/Resection)
34478 78657 19453 78591 78592 78122 78889 793 4418 79051 799 79534 79916 79915 79061 79062 78583 79085 29851 79101 30740 26382 38568 38569 79120 79121 79520 79075 836 14522 681 4497 4485 34429 859 866 17733 15524 14966 193
194
194
194
195
195
195
195
195
196
196
196
196
196
197
197
197
197
198
198
198
198
198
199
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199
199
199
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200
201
201
201
201
201
202
202
202
873 78590 267 30278 15561 4776 35454 79016 79017 79038 79040 202
202
203
203
203
204
204
205
205
205
205
Gurgaon laboratory
Code Page
Tissue Transglutaminase (tTG) Antibody (IgG) 11070 206
Tissue Transglutaminase (tTG) Antibodies 11073 206
(IgG, IgA)
Tissue Transglutaminase (tTG) Antibody (IgA) 8821 206
ToRCH 10 IgG/IgM (Toxoplasma IgG & IgM, 79531 206
Rubella IgG & IgM, CMV IgG & IgM and HSV IgG & IgM)
ToRCH 5 IgG (Toxoplasma IgG, Rubella IgG, 79530 206
CMV IgG, HSV1 IgG and HSV2 IgG)
ToRCH 5 IgM (Toxoplasma IgM, Rubella IgM, 79529 206
CMV IgM, HSV1 IgM and HSV2 IgM)
Total Protein and Albumin Panel 7577 207
Toxoplasma Antibody (IgG, IgM) 79532 207
Toxoplasma Gondii Antibody (IgG) 79911 207
Toxoplasma Gondii Antibody (IgM) 79913 207
Transferrin 891 208
Triglycerides 896 208
Typhoid IgG/IgM, Rapid Test 79882 208
Trypsin 30329 208
TSH, Ultrasensitive 899 208
TSI (Thyroid Stimulating Immunoglobulin) 30551 209
UGT1A1 Gene Polymorphism (TA Repeat) 17813 209
Urea Nitrogen (BUN) 294 209
Urea Nitrogen, 24-Hour Urine 973 209
Urea Nitrogen, Random Urine 78007 210
Uric Acid 905 210
Uric Acid , 24-Hour Urine 907 210
Uric Acid, Random Urine 14580 210
Urinalysis, Complete 5463 211
Valproic Acid, Total 79071 211
Vitamin B12 927 211
Vitamin B12 and Folate Panel, Serum 7065 212
Vitamin D, 1,25-dihydoxy 79280 212
Vitamin D, 25-Hydroxy, CLIA 78917 212
Widal Test (Tube Method) 17323 213
Widal Slide test (Rapid) 79323 213
247
248
Index by Test Name
249
250
Index for U.S. lab
U.S. laboratory
Code Page
U.S. laboratory
Code Page
Acetylcholine Receptor Binding Antibody
Acetylcholine Receptor Blocking Antibody
ACTH, Plasma
ACTIN (Smooth Muscle) Antibody (IgG)
Activated Protein C-Resistance
Aldosterone, Serum LC/MS/MS
Anti-Mullerian Hormone AssessR™
Antithrombin III Antigen
Aspergillus IgG, IgA, IgM, EIA (9941)
Aspergillus fumigatus (M3) IgE
BRAF Mutation Analysis
Brucella Antibodies (IgG, IgM)
C1 Inhibitor, Functional
C1 Inhibitor, Protein
CA 27.29
Calcitonin
Catecholamines, Fractionated, 24-Hour Urine without Creatinine
Chromogranin A, Electrochemiluminescence
Collagen Type I C-Telopeptide (CTx)
Cortisol, Free, LC/MS/MS, 24-Hour Urine
Cryptococcus Antigen Screen with Reflex to Titer
Cytomegalovirus (CMV) DNA, Qualitative, Real Time - PCR
Dihydrotestosterone, LC/MS/MS
Epidermal Growth Factor Receptor (EGFR) Mutation Analysis
EML4-ALK Gene Fusion, PCR
Endomysial Antibody Screen (IgA) with Reflex to Titer
Epstein-Barr Virus Viral Capsid Antigen (VCA) Antibody (IgG)
Erythropoietin
Estradiol, Ultrasensitive, LC/MS/MS
Estrogen, Total, Serum
Factor IX Activity, Clotting
Factor V (Leiden) Mutation Analysis
Fibrinogen Degradation Products (FDP), Semi Quantitative
FISH, ALK, 2p23 Rearrangement
FISH, EGFR
Gastrin
Glomerular Basement Membrane Antibody (IgG) (GBM Antibody)
Helicobacter pylori Antibody (IgM)
Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations
Hepatitis C Viral RNA, Genotype, LiPA‰
Hereditary Hemochromatosis, DNA, Mutation Analysis
Herpes Simplex Virus, Type 1 and 2 DNA, Real-Time PCR
Hydroxyprogesterone, 17 Alpha, Serum
206
34459 211 15043 22
17181
16842 5158 10239 60251 16767 10566 297 298 29493 30742 318 217
217
217
217
218
218
218
219
219
219
219
219
219
220
220
220
220
5428 228
16503 228
16379 17406 11280 11197 221
221
222
222
IgG Subclass 4
Inflammatory Bowel Disease Differentiation Panel
IGF Binding Protein-3 (IGFBP-3)
Insulin like Growth Factor I (IGF-I)
Ion Mobility Lipoprotein Fraction
KRAS Mutation Analysis
Lactic Acid, Plasma
Lead, Blood
Leptin
Levetiracetam (1514)
Lithium, Serum
Maternal Serum Screen 5 (Penta Screen)
Metanephrines, Fractionated, LC/MS/MS, 24-Hour Urine
Metanephrines, Fractionated, Free, LCMSMS, Plasma
Mitochondrial Antibody with Reflex to Titer
Oligoclonal Bands, CSF
Protein C Antigen
Protein S Antigen
Prothrombin (Factor II) 20210G
A Mutation Analysis
Testosterone, Free and Total, LC/MS/MS
Testosterone, Free, Bioavailable and Total, LC/MS/MS
Thiopurine S-Methyltransferase (TPMT) Genotype
Vanillymandelic Acid (VMA), 24-Hour Urine
Varicella-Zoster Virus Antibody (IgG)
Vitamin B6 (Pyridoxine)
Vitamin D, 1,25-Dihydroxy, LC/MS/MS
Vitamin D, 25-Hydroxy, LC/MS/MS
10601 222
90567 223
16460 223
16344 223
15064 223
8474
223
34458 16293 16129 16510 585 599 90367 15142 613 15934 14962 229
229
229
230
230
230
230
231
231
231
231
19548 232
259 674 4948 5165 17909 232
232
232
232
233
36170 233
14966 233
37742 233
39517 4439 926 16558 17306 233
234
234
235
235
427224
30289 224
439 224
352 224
17900 225
458
225
16114 19041 478 257
225
225
226
226
51771 226
10529 226
37811 227
35079 227
34257 227
17180 228
251
252
253
For more information on our tests and services contact:
Quest Diagnostics India Pvt. Ltd.
A-17, Info City, Sector-34, Gurgaon 122001, Haryana, India
Tel:
+91-124-4608600, 4608888
Fax:
+91-124-4608899
Toll Free: 1800-180-8378
E-mail: [email protected]
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property of their respective owners. © 2013 Quest Diagnostics Incorporated. All rights reserved.
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