Aspen hCG Pregnancy Rapid 100 Test

INTENDED USE

The hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. Human chorionic gonadotropin (hCG) is 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 1,2,3,4conceptions. hCG levels continue to rise very rapidly frequently exceeding 2,3,41 00 mlu/mL by the first missed menstrual period and peaking in the 100,000-200,000 mlU/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. The hCG One Step Pregnancy Test Device (Urine) is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mlU/mL. The test utilizes monoclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, the hCG One Step Pregnancy Test Device (Urine) Shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels. PRINCIPLE The hCG Pregnancy Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in early detection of pregnancy. The test uses two lines (C,T) to  indicate results. The test line (T) is coated with anti hcg antibodies ( monoclonal antibodies).The monoclonal antibody is  purified agglutinating sera  so making the test more reliable and accurate. The control line (C) is coated with antibodies and colloidal gold particles. The assay is conducted by adding urine specimen to the specimen well of the test device and observing the formation of red colored line (s). The specimen  migrates via capillary action along the membrane to react with the antibodies  at C & T lines. Positive specimens containing hCG (Antigen) when passes through the membrane, at test line reacts with the anti hCG antibody (Antigen - Antibody reaction). Positive reaction is made visible by colored conjugate. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line should always appear in the control line region(C). It indicates that proper volume of specimen has been added and membrane wicking has occurred. REAGENTS & MATERIALS PROVIDED Pregnancy,hCG,presncy card,preg,pregcard, pregnabcy kit,