Pregnancy (HCG) Rapid Detection Kit

INSTRUCTION FOR USE

A lateral flow immunochromatographic assay for the qualitative detection of human chorionic gonadotropin (HCG) in urine or serum specimen at sensitivity of 25mIU/ml.

PRINCIPLE

Pregnancy (HCG) rapid test is a rapid one-step test based on immunochromatographic technology. In the cassette parts a membrane with an absorbent pad over a strip of fiber glass paper is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies to HCG. Other absorbent pads at the end of the strip absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold conjugate complex, forming a pink line (“T”). Any sample will cause a pink colored line to appear in the control zone (“C”). This line is formed by the binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly.

TEST PROCEDURE

Test device and specimen should be brought to room temperature (15-30℃) prior to testing. Do not open pouches until ready to perform the assay.

• Remove the test cassette from the foil pouch and lay it a clean flat surface
• Hold the dropper vertically and transfer 2-3 drops (about 100ml) of urine to the SAMPLE WELL (S) of the test device.
• Start the timer, and read the result in 5 minutes. Do not read after 5 minutes.

Note: Depending on the concentration of HCG in the urine sample, positive results may appear within 1minute. Wait for the full five minutes to confirm the result. Do not read result after 5 minutes as this may give an incorrect test result.

This is a single use test. Please safely dispose the strip, regard it as infectious material and dispose appropriately after use.

INTERPRETATION OF RESULTS

(Please refer to the illustration)

Positive: If two pink/purple colored lines appear on the test strip, one in the control area (C) and one in the test area (T), it means HCG has been detected in the urine and there is a strong possibility of pregnancy.

The lines seen may be faint and one line may be lighter than the other; however this is still a positive result. The lines do not have to match in strength or color.

Negative: If one colored pink/purple line appears in the control area (C) on the test strip and there is no line in the test area (T), it means a negative result and no HCG has been detected in the urine, which indicates you are either not pregnant or you have tested too early. If you are not sure, repeat the test in 48 hours.

Invalid: If no lines appear anywhere on the control zone, the test is invalid. Invalid Test Results can be caused by:

• The absorbent tip not being wetted thoroughly.
• Reading the test result too early or too late. A 5 minutes reaction time is required.

Review the procedure and repeat the test with a new test device.

If the case happens again, please take below follow-up action:

If the obtained result has taken into account the possibility of false results, please do not make any decision of medical relevance without first consulting his or her physician and/or having received appropriate training.