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Our Pregnancy Cassette Test is FDA approved and CLIA-Waived. It is most commonly used in the clinical and point of care testing environment. It is a viable alternative to lab testing primarily due to the time savings, as you will have results in only a matter of minutes instead of the typical 24-48 hr laboratory wait time. Our test measures the presence of HCG (Human Chorionic Gonadotrophin) in the urine for an accurate and early detection of pregnancy. The HCG Hormone is produced by the developing placenta shortly after fertilization and is able to be detected by a home pregnancy test 7-10 days after conception. Our tests detect HCG at levels of 20 mIU/ml.
High levels of HCG are also associated with trophblastic diseases and certain nontrophoblastic neoplasms. Therefore, before the diagnosis of a pregnancy is made the possibility of other diseases must be eliminated. There are two sub units of HCG, alpha and beta. Alpha subunits of these various glycoprotein hormones are structurally very similar, but beta subunits differ in amino acid sequences. These differences are what cause their biological and immunological specificity.
The HCG test kit is based on the principle of immunochromatography. Each test device contains monoclonal anti-beta-HCG antibody/colloidal gold conjugate pre-dried on a pad. Monoclonal anti-alpha-HCG antibody (at the test region) and goat anti mouse IgG (at the control region) are coated on the membrane. When the absorbent pad is soaked with urine, the urine will migrate via capillary action toward the result window. If HCG is present in the urine, it reacts with anti-beta-HCG antibody/colloidal gold conjugate to form a complex which will move and be captured by anti-alpha-HCG antibodies to form a colored line in the test region. If the control region does not have a visually apparent line then the test is deemed invalid.