Intended Use:

Test for detection of HCG in urine or serum samples to aid early detection of pregnancy.

Introduction:

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 urine and serum 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 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of HCG in both 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. The HCG 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.

Method Principal:

The HCG Pregnancy Test Card is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine/serum to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by applying sample in the sample well and observing the formation of coloured lines. The specimen migrates via capillary action along the membrane to react with the coloured conjugate. Positive specimens react with the specific antibody-hCG coloured conjugate to form a coloured line at the test line region of the membrane. Absence of this coloured line suggests a negative result. To serve as a procedural control, a coloured line will always appear at the control line region if the test has been performed properly.