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.

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.

Test Procedure

1. Remove the HCG Pregnancy test cassette from foil pouch. Use cassette t within 1 hour after removal from pouch

2. Draw the urine specimen using the dropper provided, and dispense 3 drops (approx. 0.1 mL) onto the sample well of the cassette (see diagram).

3. Wait for red lines to appear. The test should be read in approximately 3-5 minutes. Do not interpret results after 5 minutes.

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.

Limitation

1. As it is with any diagnostic procedure, a confirmed pregnancy diagnosis should only be made by a physician after evaluating all clinical and laboratory findings. 2.If a urine sample is too dilute (ie, low specific gravity) it may not contain a representative level of hCG. If pregnancy is still suspected, another urine specimen should be collected 48 hours later and tested.

3. Low concentration of hCG in a very early pregnancy can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.

4. Elevated levels of hCG can be caused by a few conditions other than pregnancy. Therefore, the presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.

5. A normal pregnancy can not be distinguished from an ectopic pregnancy based on Hcg Levels alone. Also, spontaneous miscarriage may cause confusion in interpreting test results.

6. Sterility treatments, based on hCG, may cause false results. Please consult your physician for further diagnose.