Description

The Diagnostic Automation, Inc. Human Chorionic Gonadotropin (HCG) ELISA kit is intended to use for quantitative determination of HCG. HCG is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, HCG can be detected in serum as early as 7 days following conception, doubling every 1.3 to 2 days. At the time of the first missed menstrual period, serum HCG concentration is about 100 mIU/ml, and peak levels of 100,000~200,000 mIU/ml are seen at the end of the first trimester.

The appearance of HCG soon after conception and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy. Elevated serum HCG levels comparable to those observed in early pregnancy may also be associated with trophoblastic or nontrophoblastic neoplasms such as hydatidiform mole, choriocarinoma; therefore, the possibility of such diseases should be ruled out before a positive HCG result is considered diagnostic for pregnancy. The HCG Visual Test Kits is a rapid test to detect the presence of HCG in urine or serum specimens in a qualitative format.

The HCG Visual Test Kit is based on a solid phase enzyme-linked immunosorbent assay. The assay system utilizes one anti-HCG antibody for solid phase (microtiter wells) immobilization and another mouse monoclonal anti-HCG antibody in the antibody-enzyme (horseradish peroxidase) conjugate solution. The test specimen (serum or urine) is added to the HCG antibody coated microtiterwells and incubated with the HCG antibody labeled with horseradish peroxidase (conjugate). If HCG is present in the specimen, the HCG molecules will be sandwiched between the solid phase and enzyme-linked antibodies. After incubation at room temperature, the wells are washed with water to remove unbound labeled antibodies. A solution of TMB is added and incubated for five minutes, resulting in the development of a blue color. The color development is stopped with the addition of 2N HCl, and the color is changed to yellow and measured spectrophotometrically at 450 nm.