Pregnancy test is a rapid chromatographic immunoassay for quallitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test utilizes monocional antibodies to selectively detect elevated levels of human chorionic gonadotropin in urine. The pregnancy test card demonstrates an overall accuracy greater than or equal to 99.7%.

A urine specimen must be collected in a clean and dry container. A first morning urine specimen is preferred. Remove the testing device from the foil pouch by tearing at the notch. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 uL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). Wait for the colored line(s) to appear. The result should be read at 3-5 minutes. Note that a low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.

Do not use after expiration date. Do not use test if pouch is damaged. Handle all specimen as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow standard procedures for proper disposal of specimens. Humidity and temperature can adversely affect results.

POSITIVE: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the test line region (T). Note that the intensity of the color in the test line region (T) may vary depending on the concentration of hCG present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. NEGATIVE: One colored line appears in the control line region (C). No apparent colored line appears in the test line region (T). INVALID: Control line falls to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test.

Store as packaged in the sealed pouch either at room temperature or refrigerated(2-30°C). The test Strip is stable through the expiration date printed on the kit. The test must remain in the sealed pouch until use. Do not freeze.

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