Intended Use

Human chorionic gonadotropin (HCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both serum and urine as early as 7 to 10 days after conception. Hcg Levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100-200 IU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.

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

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.