(1)The hCG One Step Pregnancy Test Strip (Urine) is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/mL.The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine.At the level of claimed sensitivity, the hCG One Step Pregnancy Test Strip (Urine) shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
(1)The hCG One Step Pregnancy Test Strip (Urine) detects hCG at a concentration of 25 mIU/mL or greater. The test has been standardized to the W.H.O.Third International Standard.The addition of LH (300 mIU/mL), FSH (1,000 mIU`/mL),and TSH (1,000 mIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no cross-reactivity.
3.Interpretation of Results
(1)Positive:Two distinct red lines appear.One line should be in the control region (C) and another line should be in the test region (T).
(2)Negative:One red line appears in the control region (C).No apparent red or pink line appears in the test region (T).
(3)Invalid:Control line fails 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 strip. If the problem persists,discontinue using the test strip immediately and contact your local distributor.
(4)Note:The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen.However,neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.