Infectious disease test kit

AIDSfor antibodiesHTLV-1

Derived from purified and inactivated HIV-1 viral lysate proteins, the Avioq HIV-1 Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to HIV-1 (a leading causal agent of AIDS in the U.S.) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with the OraSure® HIV-1 Oral Specimen Collection Device. The Avioq HIV-1 Microelisa System is intended for use as an aid in diagnosis of infection with HIV-1. It is not intended for use in screening blood donors. Developed as a standard two-step indirect microelisa system assay, the Avioq HIV-1 Microelisa System contains coated 96-well microwell plates, color-coded, liquid calibrator and positive control, and a ready-to-use liquid substrate. The sample diluent contains sample addition monitoring to allow visualization of color change upon sample addition to microwells. Kit Configuration and Principle of Test The product is available in three kit configurations, the 384, 960, and 9600 test kits. Please refer to the 'Literature' tab for additional information, as well as the performance characteristics of this product. The Package Insert is available on the 'Support' menu tab. The Avioq HIV-1 Microelisa System uses HIV-1 antigens, including inactivated, purified HIV-1 viral lysate proteins, which are coated on the wells of microwell plates, for the detection of antibodies against HIV-1. Upon addition of a diluted test specimen containing antibodies to HIV-1 to a microwell, immune complexes are formed through the interaction between the anti- HIV in the specimen and the HIV antigens coated on the microwell.