Products - Human Chorionic Gonadotropin (HCG) Test Midstream (Colloidal Gold Immunochromatographic Assay) Product Description - Sensitivity: 25 mIU/ml Accuracy: > 99.5% ISO13485 & CE approved INTENDED USE Easy-Sweet hCG Test Midstream is an in vitro diagnostic (IVD) qualitative test for rapid detection of hCG in urine. This test is designed for self-testing use only. PRINCIPLE Easy-Sweet. hCG Midstream is two-side sandwich immunoassay for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The membrane was precoated with anti alpha hCG capture antibodies on the test band region and goat anti mouse on the control band region. During the test, the urine specimen is allowed to react with anti beta hCG monoclonal antibody-colloid gold conjugate, which was predried on the test Midstream. The mixture then moves forward on the membrane by the capillary action. For a positive specimen, the conjugate binds to the hCG forming an antibody-antigen complex. This complex is captured by anti alpha hCG antibody on the test region to produces a visual pink color band when hCG concentration in specimen is equal to or greater than 25 mIU/ml. Regardless of the presence of hCG, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized goat anti mouse antibodies to form a distinct pink colored control band. The presence of the control band indicated: 1) a normal flow is obtained, 2) antibody pre-coated on control line and colloidal gold conjugate are functional. 1 pc/individual pouch , 500pcs/ctn or customized
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