INTENDED USE One-Step Anti-HIV 1/2Rapid Test is a rapid, one-step, visual test for the qualitative detection of antibodies to Human Immunodeficiency Virus Type I and 2 (HIV-1+2) in whole blood,serum or plasma. It is intended to be used as an aid in the diagnosis of infection with HIV 1 and HIV 2.
PRINCIPLES OF THE TEST The test is a one-step, qualitative, double antigen sandwich lateral flow immunochromatographic assay.There are two regions, test region and control region, an the membrane of the test strip. When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HIV antibodies (anti-HIV) will bind with the gold conjugated antigens forming complexes. The HIV antigen colloidal gold conjugate complexes with the Anti-HIV in the test specimen and travels on the membrane due to capillary action along with the rabbit IgG colloidal gold conjugate. This complex moves further on the membrane to the test region (T) where it is immobilized by HIV antigen coated on the membrane. The recombinant antigen immobilized on the membrane will capture the antibody-antigen-colloidal gold complex and form a colored test band on the membrane.
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