TEMPLATE FOR STANDARD OPERATING PROCEDURES



POCT – BIOSIGN? hCG NEW ONE STEP PREGNANCY TEST1. INTRODUCTION1.1 Purpose of the ProcedureHealthcare 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 pregnancy1.2 StaffOnly healthcare personnel who have been suitably trained may perform pregnancy testing using the BioSign? hCG - One Step Pregnancy Test.2. PRINCIPLE OF THE PROCEDUREUrine 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 REQUIREMENTSAny 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 SAFETYAll patient samples are a potential infection risk. Follow appropriate procedures (e.g. use gloves). Cover cuts and abrasions on own hands and forearms with water-repellent ‘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 INSTRUMENTATIONTimer capable of measuring 3 minutes accurately.6. REAGENTS, STANDARDS, CALIBRANTS AND CONTROLSThe 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. METHODCollect urine sample.Check expiry date on cassette pouch.Tear open pouch and remove cassette and dropper.Write patient ID on test cassette and place on a flat surface Draw sample into dropper by first squeezing 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.8. QUALITY CONTROLHolding 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.Read result at 3-5 minutesDO NOT read results after 5 minutes8. LIMITATIONS OF THE EXAMINATIONAs with any diagnostic procedure, the result should be evaluated with all clinical findings.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.The hCG level may remain detectable for several weeks after normal delivery, delivery be caesarean section, spontaneous miscarriage or therapeutic abortion.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.Elevated levels of hCG can be caused by a few conditions other than pregnancy. A normal pregnancy cannot be distinguished from an ectopic pregnancy based on hCG levels alone.9. RECORDING AND CALCULATION OF RESULTSPositive: 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 RANGEShCG 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.11. REPORTING AND VALIDATION OF RESULTSThe 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. REFERENCESBioSign 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 .uk for the most up to date copy of the MHRA POCT Pregnancy Testing Top Tips. ................
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