BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: POCT BioSign® New One Step Pregnancy Test
Q Pulse Reference No: BS/CB/POCT/SOPS/21
Authoriser: Francesca Mills
Version NO: 1.0
POCT – BIOSIGN® hCG NEW ONE STEP PREGNANCY TEST
1. INTRODUCTION
1.1 Purpose of the Procedure
Healthcare professionals may use the BioSign® hCG - One Step Pregnancy Test for
the qualitative detection of human chorionic gonadotrophin (hCG) in urine for the
early detection of pregnancy
1.2 Staff
Only healthcare personnel who have been suitably trained may perform pregnancy
testing using the BioSign® hCG - One Step Pregnancy Test.
2. PRINCIPLE OF THE PROCEDURE
Urine is added to the sample well of the test cassette using a dropper and allowed to
soak in. If hCG is present in the specimen, it will react with the conjugate dye, which
binds to the antibody on the membrane to generate a coloured line. Presence of two
coloured lines, one at the Test position and the other at the Control position indicates
a positive result, while the absence of the line at the Test position indicates a
negative result.
3. SPECIMEN REQUIREMENTS
Any urine sample is appropriate for pregnancy testing but the first morning urine
specimen is optimal for the detection of early pregnancy. The urine should not be too
dilute.
Samples should be collected in a clean, dry container such as a foil bowl or plain
universal.
All sample containers must be labelled before leaving the patient.
4. HEALTH AND SAFETY
All patient samples are a potential infection risk. Follow appropriate procedures (e.g.
use gloves). Cover cuts and abrasions on own hands and forearms with waterrepellent ‘island’ type plasters. If hands do become contaminated with urine, wash
immediately with soap and water.
After testing, all used materials should be discarded into clinical waste in accordance
with ward/site procedures.
5. EQUIPMENT AND INSTRUMENTATION
Timer capable of measuring 3 minutes accurately.
Page 1 of 4
If printed this document is uncontrolled and only valid on day of printing.
Please refer to the POCT website for the most up to date version.
BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: POCT BioSign® New One Step Pregnancy Test
Q Pulse Reference No: BS/CB/POCT/SOPS/21
Authoriser: Francesca Mills
Version NO: 1.0
6. REAGENTS, STANDARDS, CALIBRANTS AND CONTROLS
The BioSign® hCG - One Step Pregnancy Test kits should be stored at 2-30°C in the
original sealed pouch. It is capable of detecting hCG level of 25 mIU/mL in urine
(calibrated against the WHO 3rd International Standard).
7. METHOD
1. Collect urine sample.
2. Check expiry date on cassette pouch.
3. Tear open pouch and remove cassette and
dropper.
4. Write patient ID on test cassette and place
on a flat surface
5. Draw CONTROL
sample into dropper by first squeezing
8. QUALITY
the dropper bulb to create a vacuum, then
dipping the dropper end into the sample and
releasing the dropper bulb.
NOTE: Avoid introducing air bubbles into the
dropper.
6. Holding dropper vertically, squeeze the
dropper to dispense 3 full drops into the test
sample well.
NOTE: Do not touch sample well or test
cassette with the tip of dropper.
7. Read result at 3-5 minutes
8. DO NOT read results after 5 minutes
Page 2 of 4
If printed this document is uncontrolled and only valid on day of printing.
Please refer to the POCT website for the most up to date version.
BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: POCT BioSign® New One Step Pregnancy Test
Q Pulse Reference No: BS/CB/POCT/SOPS/21
Authoriser: Francesca Mills
Version NO: 1.0
8. LIMITATIONS OF THE EXAMINATION
1. As with any diagnostic procedure, the result should be evaluated with all
clinical findings.
2. False negatives results may occur in very early pregnancy or if the urine
specimen is very dilute. If pregnancy is still suspected, another urine sample
should be collected 48 hours later and tested.
3. The hCG level may remain detectable for several weeks after normal delivery,
delivery be caesarean section, spontaneous miscarriage or therapeutic
abortion.
4. Positive results from very early pregnancy may later prove negative due to
natural termination of pregnancy. Natural termination occurs in 22 % of
clinically unrecognised pregnancies and 31% of pregnancies overall.
5. Elevated levels of hCG can be caused by a few conditions other than
pregnancy.
6. A normal pregnancy cannot be distinguished from an ectopic pregnancy
based on hCG levels alone.
9. RECORDING AND CALCULATION OF RESULTS
Positive: Two pinkish-purple lines, one each at the Test position (T) and at the
Control position (C). The colour intensity of the test line varies with hCG
concentration.
Negative: Only one pinkish-purple line at the Control position (C).
Invalid: No lines visible or a test line only. Repeat with a new cassette.
10. REFERENCE RANGES
hCG levels in normal pregnancy vary and hCG levels often exceed 100 mIU/mL by
the first day of the missed menstrual period. The test is usually capable of detecting
hCG by the first day of the missed menstrual period.
Page 3 of 4
If printed this document is uncontrolled and only valid on day of printing.
Please refer to the POCT website for the most up to date version.
BLOOD SCIENCES
DEPARTMENT OF CLINICAL BIOCHEMISTRY
Title of Document: POCT BioSign® New One Step Pregnancy Test
Q Pulse Reference No: BS/CB/POCT/SOPS/21
Authoriser: Francesca Mills
Version NO: 1.0
11. REPORTING AND VALIDATION OF RESULTS
The test strip lot number, expiry date, person performing the test and the result
should be recorded on a record sheet and in the patient notes.
Any equivocal results should be repeated using a fresh urine sample and/or send a
blood sample to the laboratory for quantitative analysis.
12. REFERENCES
BioSign Instructions for Use (Q Pulse Reference No: BS/CB/POCT/SOPS/21).
Pack insert included in every box of BioSign® hCG – One Step Pregnancy test kit.
See www.mhra.gov.uk for the most up to date copy of the MHRA POCT Pregnancy
Testing Top Tips.
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If printed this document is uncontrolled and only valid on day of printing.
Please refer to the POCT website for the most up to date version.