Download Pathology Directorate F Examination Process F2 Examination

F Examination Process
F2 Examination procedures
Printed on : 29/06/2017
Pathology Directorate
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Blood Sciences
Section : Point of Care
Pregnancy Testing Clinitek STATUS Urine Analyser.
Site/Area of application
Point of Care
Index code
BSF2POC037 v1
Superseded documents
BIMECUA4 v 4
Implementation date of this version
4th August 2010
Approver of content of SOP
Uche Okeahialam
Reason for change
Review and update to current SOP template
Keywords for search on EQMS
Poct, Urine, Pregnancy, Status, Clinitek, Sample.
Author: Rob Coleman
This document is controlled using the Pathology EQMS software.
Controlled printed copies can be identified by the authorisation signature present in the space below. Upon request further authorised
copies can be obtained through the department’s quality system.
Uncontrolled copies may be printed for an individuals use but should not be used after 1 week from the date of printing.
Signature
1.
CLINICAL RELEVANCE/PURPOSE OF PROCEDURE
Pregnancy testing
2.
PRINCIPLE OF PROCEDURE
NOTE The Clinitek urine analysers may be used immediately after being turned on and the self-test is
complete. No warm up time is required. Human chorionic gonadotrophin (hCG) in urine is detected using
the Clinitest hCG Pregnancy test. This is a rapid chromatographic immunoassay. Absence of a pink line in
the test region indicates a negative result. A pink line in the control region serves as verification that
sufficient sample has been added to the cassette.
The test is only intended for use with the Clinitek Status Urine Analyser.
3.
PERSONNEL / TRAINING REQUIREMENTS
a)
Training Requirements
A short training course for ward users given by Bayer, Biochemistry Staff or an
authorised trainer nurse.
b)
Maintenance Quality Control and Troubleshooting
Carried out by Biochemistry staff.
4.
SPECIMEN REQUIREMENTS
Clinitest hCG:- Sample type :- Plain
urine
Minimum volume :- 200 µL
Stored at :- 2˚-8˚C up to 72 hours. Sample must be returned to room temperature
before analysis.
Means of identification :- Name or Hospital number.
INDEX CODE: BSF2POC037 version 1
TITLE: Pregnancy testing using Clinitek STATUS urine analysers.
Page 1 of 4
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 29/06/2017
5.
EQUIPMENT
Paper towels.
Clinitest hCG cassette.
6.
HEALTH AND SAFETY/RISK ASSESSMENT
See the COSHH assessment BICOSHH153
7.
REAGENTS
Clinitest® hCG cassettes Ref. 1760 (06484105).
Store at room temperature (2° C- 30° C) or refrigerate. If refrigerated allow the wrapped cassette to reach
room temperature before use.
8.
CALIBRATION
The analyzer performs an automatic calibration each time a test is run. The assay is calibrated to the
World Health Organisation 3rd International Reference Preparation.
9.
QUALITY CONTROL
Kenlor dropper QC Normal and abnormal Quality Control Solutions
UK, Biostat House, Pepper Road, Hazel Grove.
Store at 2-8C
Kit inserts are kept centrally in OMS.
Cat no 210306 Inverness Medical
Internal Quality control is analysed weekly by POCT staff.
All internal QC results and strip lot number used, must be recorded on “Urine IQC results” file
situated in the POCT folder on “G” drive.
Any results not complying with set limits results in troubleshooting procedure being applied.
10.
COMPUTER / TELEPATH CODES
N/A
11.
PROCEDURE OR METHODOLOGY
If the analyzer is switched off, press the ON/OFF button located on the front of the analyzer. The analyzer
runs an automatic system diagnostic test.
1. Ensure the sample table is set up for a cassette test. If not remove and reverse the table insert.
2. Touch “Enter new operator ID”. Use the keyboard to enter your ID. Touch “Enter”.
3. Touch “Enter New Patient”. Use the keyboard to enter patient name or QC. Touch “Enter”.
4. The next screen requires you to enter patient ID. Use the keyboard to enter patient ID or QC type.
Touch “Enter”.
5. Touch ”Clinitest hCG Cassette”.
6. Remove the test cassette and pipette from the foil package and place the cassette on the test table.
7. Draw the urine sample to the line marked on the pipette.
8. Touch the “START” button. NB. Once you touch the “START” button you have 8 seconds to pipette the
urine into the well.
9. Empty the entire contents of the pipette into the sample well of the test cassette. At the end of 8
seconds the cassette will automatically be pulled into the instrument. A timer will count down the time
remaining before the results are printed.
10. Remove the used cassette and place it in a “clinical waste” bin.
11. The table insert may be disinfected with Presept or similar solution then rinsed with water and dried.
DO NOT IMMERSE the WHITE CALIBRATOR BAR.
Recording results :- Results should be recorded in the patient’s notes.
Disposal of waste :- Discard used strips into an infected waste bin.
If you are experiencing problems with the analyser, contact Biochemistry. Bleep 2310, 2311, 1801, 1804,
or 2320. Tel.ext. 22338.
INDEX CODE: BSF2POC037 version 1
TITLE: Pregnancy testing using Clinitek STATUS urine analysers.
Page
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If the machine is not repairable by the laboratory, it must be returned to the manufacturer : Siemens
Medical Solutions Diagnostics, Sir William Siemens Square, Frimley, Camberley, Surrey, GU168QD. Tel
0845 600 1955, have the meter serial number to hand as if the machine is on service contract, then repair
is free. If not on contract an order number must be supplied.
This test is not intended to detect conditions other than pregnancy. A number of
conditions other than pregnancy, including trophoblastic disease, and certain
nontrophoblastic neoplasms, can cause elevated levels of hCG.
The test does not diagnose ectopic pregnancy or molar pregnancy. A suspected
ectopic pregnancy should be further evaluated using the laboratory hCG assay.
Because of the lag between conception and the appearance of hCG in urine, to
exclude pregnancy Negative test results in patients suspected to be pregnant should
be re-tested with a sample obtained 48 to 72 hours later or by performing a
quantitative plasma hCG.
Patients on antibody therapies may obtain invalid results due to interfering
antibodies in the medications.
The presence of heterophile antibodies or non-specific protein binding may cause
false-positive results. If a test result is inconsistent with the clinical evidence, results
should be confirmed by an alternative hCG detection method
Disinfection procedures for equipment :- Damp tissue moistened with soapy water.
High risk samples – Normal sample precautions
12.
UNCERTAINTY OF MEASUREMENT
All qualitative pregnancy tests will produce a small number of false positives (<1%).
Reasons for a Borderline/Positive result in women who are NOT pregnant:Low levels of hCG in women of childbearing age are sometimes observed due to a
recent pregnancy that has spontaneously aborted (about 22% of pregnancies abort
spontaneously, without being detected).
hCG levels may remain detectable for up to several weeks following delivery,
miscarriage or hCG injections (IVF)
Passively acquired hCG from a blood transfusion
An ectopic pregnancy
Trophoblastic diseases e.g. an ovarian tumor or hydatidiform mole
The use of some fertility drugs
The presence of interfering substances, such as endogenous proteins, drugs, micro organisms,
erythrocytes and/ or leucocytes.
The presence of heterophile antibodies or non-specific protein binding
13.
REFERENCE RANGE / ACTION LIMITS
POSITIVE if hCG > 25 mIU/mL
BORDERLINE Result is indeterminate – repeat in 48-72 hours.
NEGATIVE if hCG < 25 mIU/mL
INVALID if a procedural error is detected or reagent deterioration has occurred.
Dealing with abnormal or unexpected results
INDEX CODE: BSF2POC037 version 1
TITLE: Pregnancy testing using Clinitek STATUS urine analysers.
Page
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As with any diagnostic test, clinical diagnosis should not be based solely on a single test result.
If there is any doubt about the validity of a result, or where the patient clinical condition does not
correspond to the result, then sample should be retained and sent to the laboratory for further analysis. If
necessary, discuss with the laboratory staff.
Clinical Interpretation
For pregnant women, hCG levels of 100 mIU/mL can be reached on the day of the first missed
menstrual period. hCG levels peak about 8-10 weeks after the last menstrual period and then
decline to lower values for the remainder of the pregnancy. Values approaching the cut off of the
test (25 mIU/L) may be achieved very early following conception but due to the wide variation in
hCG secretion in each pregnancy the rapidity with which a positive result appears, and the density of the
band, are neither an indication of the total hCG present, nor the gestational age. hCG levels rapidly
decrease and usually return to normal within days after delivery.
14.
REFERENCES
Training in this procedure is recorded using the generic training record BSF2POC020
The quality records for this procedure are kept in the POCT IQC file on G drive.
15.
APPENDICES
N/A
INDEX CODE: BSF2POC037 version 1
TITLE: Pregnancy testing using Clinitek STATUS urine analysers.
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