Intended Use

The Pregnancy One Step Rapid Test Cassette is a rapid, one step test for the qualitative detection of human chorionic gonadotropin (HCG) in urine, as an aid for the early detection of pregnancy. The test is intended for in vitro diagnostic self-testing.

Principle

The Pregnancy One Step Rapid Test Cassette adopts the principles of double antibody sandwich method and immunochromatography to test the human chorionic gonadotropin (hCG) in the urine. The membrane is pre-coated with anti-hCG antibodies in the test region (T) and anti-mouse antibodies in the control region (C). During testing, the urine sample reacts with the colored conjugate (mouse anti-hCG antibody colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upward on the membrane to react with anti-hCG antibodies in the test region and generate a red line. Presence of the red line indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG, as the mixture continues to migrate across the control region, a red line at the region will always appear. The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.

Storage and Stability

1. Store as packaged in the sealed pouched at room temperature (2-30℃). The kit is stable within the expiration date printed on the labeling.

2. Once open the pouch, the test strip should be used within 1 hours. Prolonged exposure to ambient humidity will cause product deterioration.

Specimen

The first morning urine is preferred since it generally contains the highest concentration of hCG. However, urine at any time of day may be used. Urine

specimens may be stored at 2-8 ℃ for up to 72 hours prior to assay.

Interpretation of Results

Positive: Two distinct red lines will appear, one in the test region (T) and one in the control region (C).Positive test results are possible but not definitive for the diagnosis of pregnancy. It is strongly recommended that an additional urine specimen be obtained after 48-72 hours and tested again, or consulting your physician.

Negative: Only a single red line appears in the control region (C). No apparent red or pink line appears in the test region (T). Negative test results mean that you may not be pregnant.However, you should re-test with the first morning specimen obtained 48-72 hours later.

Invalid: Control band fails to appear which means improper testing procedures or deterioration of reagents probably occurred. In any event, repeat the test. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Notes: The shade of red color in the test region (T) will vary depending on the concentration of hCG present. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.