Intended Use

The Pregnancy One Step Rapid Test Strip 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

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

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

Test Procedure

1.Remove the test strip from foil pouch. Use strip as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30℃ and in high humidity environment.

2.Immerse the test strip in the urine sample with printed sample end pointing toward the urine for at least 10 seconds. Be sure the sample level is below the marked sample line (MAX) on test strip.

3.Take the strip out and lay the strip flatly on a non-absorptive clean surface. 4.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.