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Biomedical Diagnostics 1
Ch.1 related data
INTEGRATING LAB DATA
INTO TCM PRACTICE
Healthcare:
Complex
Driven by technology
Tests help formulate strategy
Recognize Red Flags
Prepare for evidence based practice
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HIPPA AND LAB REPORTS
Covers sharing of lab reports
DNA tests?
Web based tests?
Point of Care (POC) tests
CLIA (Clinical laboratory Improvement Act 1988)
CLIA Waived
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USING LABORATORY DATA
CLINICIAN’S TASKMake reasoned decisionsIn certain situations diagnostic tests are mandated
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Categories of testing
Screening
Diagnostic
Patient management
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SCREENING
Helps in identifying risk factorsIn early detection of “occult” diseasesBenefits, Costs and Risks must be
considered
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CRITERIA FOR SCREENING
POPULATION:
NATURE OF THE DISEASE:
TEST CHARACTERISTICS:
GOOD SENSITIVITY & SPECIFICITY
LOW COST AND RISK
Home Test Kits- Txt Book Table 1-4 page 13
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0.45
0.4
0.35
Page 5
Height of Curve
0.3
0.25
0.2
0.15
0.1
0.05
0
-3
-2
-1
0
1
2
3
Standardized Score (Z-score)
Bell Curve and Standard Deviation (SD)
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REFERENCE RANGE
Method and laboratory specific
Reflects results found in 95% of a
healthy population
Means 5% will have ‘false positive’
results
Therefore ‘borderline’ results must be
viewed critically
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Main Criteria (page 7-9)
Sensitivity
&
Specificity
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SensitivitySensitivity= TP/(TP +FN)
SpecificitySpecificity= TN/(TN + FP)
TN= True Negatives
TP= True Positives
FP= False Positives
Sensitivity & Specificity
(SnNouts and SpPins)
Definition
Sensitivity refers to the proportion of people:
with disease who have a positive test result.
Specificity refers to the proportion of people:
without disease who have a negative test result.
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SpPins and SnNouts
SpPin is a mnemonic applied to the finding that
when a sign, test or symptom has a
high Specificity, a
Positive result rules in (SPin) the diagnosis.
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SpPins and SnNouts
SnNout is a mnemonic applied to the finding
that when a sign, test or symptom has a
high Sensitivity, a
Negative result rules out (SNout)
the diagnosis.
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EVIDENCE BASED MEDICINE (page 19)
FOR SOUND METHODOLOGY
CRITICAL APPRAISAL OF RESEARCH
DATA
PUBLISH ACCURATE & CLINICALLY
USEFUL SUMMARIES OF EVIDENCE
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POINT OF CARE (POC) TESTS
URINALYSIS
‘SCREENING TESTS’(page 2)
SIMPLE BLOOD TESTS
?HOME TEST KITS
DAT: Direct Access Testing
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Collection Tubes
Additives
• Preservatives
• Anticoagulants
Gel separation tubes
Serum tubes
Plasma tubes
Trace element-free tubes
Pediatric tubes (3 mL)
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B. BLOOD COLLECTION
Site: Arteries, Veins,
Capillaries
Component Types used for testing:
• Blood
Whole
Plasma
Serum
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PLASMA
“... the river in which the blood cells travel.”
Contains:
1. Water
2. Nutrients
(sugars, amino acids, fats, electrolytes, minerals, etc.)
3. Waste products (CO2, lactic acid, urea, etc.)
4. Antibodies (immunoglobulins)
5. Clotting proteins (called clotting factors)
6. Hormones
7. Complement Proteins
(inflammation, immune response)
8.Transport Proteins (albumin)
60% Total Blood Volume
Plasma = serum + clotting components
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Lipemia :
Can cause factitious
Hyponatremia,
Hypokalemia,
Hyperchloremia
Turbidity -Due to lipid particles; causes light to
scatter...interferes with photometry
Partitioning Error -Analyte can enter lipid…making it
inaccessible for chemical reaction
Electrolyte Exclusion Effect -Triglycerides > 1500mg/dL (milky serum):
Fat replaces serum water, which alters
distribution & conc. of electrolytes
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Some Lab Methods
Microbiology- Gram staining- first stain with crystal
violet- wash- then second stain with Grams iodinerinse after decolorizing with alcohol-counter stain
with safranin and rinse and dry;
Gram negative stain pink
Gram positive stain purple
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URINE
&
RENAL
TESTS
Discuss:
A.Components
of Urine
B.Collection
of Urine
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A. Urine Components:
Color: Yellow, Amber, Red,Orange
Clarity: Clear, Cloudy
Microscopy: Normal/Abnormal cells,
crystals,
Chemistry Testing:
Electrolytes
Kidney function testing
Glucose
Heavy metals
Drug Screens
Protein
Uric Acid
Calcium
… & more
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B. Collection of Urine:
Random or timed
Sterile plastic container
With/without
preservatives
“Clean Catch”
• Cleanse skin
• Collect midstream sample
Catheter
Suprapubic
2 L collection jug
Children
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Timing of Urine Collection:
1.Random Urine Collection
Examples:
•First morning void:
(best for drug analysis)
•2- or 3-hour post-prandial:
(glucosuria)
•Afternoon:
(urobilinogen)
•Anytime: urinalysis,
urine pregnancy
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2. Timed Urine Collection:
• Specified intervals (2-, 12-, 24-hour)
• Special instructions - diet, drugs, collection
technique, preservatives
• How to collect?
1) empty bladder & discard (“first void” urine)
2) Record time and begin urine collection
3) Store container @ 4C between collections
(preservative may be required)
4) Record time and volume at the end of
collection interval
24-hour
Why?  diurnal variation of analyte
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Urine test (page 31-32)
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Urine Color Chart
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Crystals Seen in Urine
Normal: calcium oxalate, triple phosphate crystals and amorphous phosphates
Very uncommon crystals include:
cystine crystals in urine of neonates with congenital cystinuria or severe liver disease,
tyrosine crystals with congenital tyrosinosis or marked liver impairment, or
leucine crystals in patients with severe liver disease or with maple syrup urine disease
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little envelopes
or tetrahedrons –
Oxalate (common)
stop signs –
Cystine (rare)
rectangles –
triple phosphates
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‘Renal’ Tests
Creatinine Clearance, page 90
GFR, (198)
CMP,
BUN, (63)
Creatinine, (89)
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GFR Significance
Kidney Damage
Stage
Description
GFR
Other findings
1
Kidney damage with
normal or high GFR
90+
Protein or albumin in
urine are high, cells or
casts seen in urine
2
Mild decrease in GFR
60-89
3
Moderate decrease in
GFR
30-59
4
Severe decrease in GFR
15-29
5
Kidney failure
< 15
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Serum assessment of Renal function
BUN- 8-25 mg/dL
Creatinine- 0.6-1.5 mg/dL
>1.5 = 50% nephron loss
>4.8 = 75% loss
~10 = 90% loss (ESRD)
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BUN:Creatinine ratio
Normal: 10:1 ~20:1.
An increased ratio may be due to a condition that causes a
decrease in the flow of blood to the kidneys:
such as congestive heart failure or dehydration, increased
protein, from gastrointestinal bleeding, or increased protein in the
diet.
The ratio may be decreased with liver disease (due to decrease
in the formation of urea) and malnutrition.
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?Uric Acid (213)
Produced by the breakdown of purines
Purines are chemicals that come from nucleic acids (DNA)source:-cells and food
Most uric acid is removed by the kidneys and disposed of in the
urine
Gouty arthritis, also known as gout, is a condition caused by the
deposition and accumulation of needle-like uric acid crystals in the
fluid and tissues of one or more joints.
This causes inflammation, swelling, and severe pain in the joint.
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Uric Acid
Purine metabolism
‘Gout’
Diuretics- thiazides/lasix
Pre eclampsia/eclampsia
Excessive cell destruction –CCT
Prolonged fasting
M- 3.6-8.5 mg/dL ; W- 2.3-6.6 mg/dL
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FOODS RICH IN PURINES
ANCHOVIES
ASPARAGUS
KIDNEYS
LIVER
LENTILS
SARDINES
SPINACH
SWEETBREADS
Note!:
Purines are part of
nucleic acid
metabolism
Destruction of DNA
as it happens in
cancer chemotherapy
can result in elevated
serum uric acid levels
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Do NOT Confuse! List
Creatine- consumption of high glycemic carbohydrates in conjunction with creatine increases
creatine muscle stores and performance. (Cell-TechⓇ-creatine-carbohydrate-alpha lipoic acid
supplement )
Creatinine- Creatinine is a break-down product of creatine phosphate in muscle. Creatinine
clearence measures kidney GFR
Creatine Kinase (CK)
Creatine phosphokinase (CK)- Creatine kinase (CK), also known as phosphocreatine
kinase or creatine phosphokinase (CPK) is an enzyme expressed by various tissue types. It catalyses the conversion
of creatine to phosphocreatine, consuming adenosine triphosphate (ATP) and generating adenosine diphosphate
(ADP).
Clinically, creatine kinase is assayed in blood tests as a marker of myocardial infarction
(heart attack), rhabdomyolysis (severe muscle breakdown), muscular dystrophy and in
acute renal failure.
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Metabolic Panels

1.
2.
3.
4.
5.
BASIC-information about the current
status of kidneys, blood sugar, and electrolyte
and acid/base balance.
Glucose
Calcium
Sodium
Potassium
CO2 (carbon dioxide,
bicarbonate)
6. Chloride
7. BUN (blood urea nitrogen)
8. Creatinine
 COMPREHENSIVE
1. Glucose
2. Calcium
3. Sodium
4. Potassium
5. CO2 (carbon dioxide, bicarbonate)
6. Chloride
7. Albumin
8. Total Protein
9. BUN (blood urea nitrogen)
10. Creatinine
11. ALP (alkaline phosphatase)
12. ALT (alanine amino transferase,
SGPT)
13. AST (aspartate amino transferase,
SGOT)
14. Bilirubin
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ACID BASE BALANCE page 392-393
Renal Failure-462
Urinalysis in disease states-479
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