Access HIV Combo V2 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

Intended use: Semi-quantitative immunoassay for the detection of HIV p24/p26 antigens and antibodies to HIV1/O/2 inhuman serum and plasma using the Access Immunoassay Systems.

Functional description

The Access HIV combo V2 assay is an immunoenzymatic assay based on the sandwich principle. The Access HIV combo V2 assay is a paramagnetic-particle, semi-quantitative chemiluminescent immunoassay (CLIA) for the detection of HIV-1 p24 and HIV-2 p26 antigens and antibodies to HIV-1 and HIV-2 in human serum or plasma using the Access Immunoassay Systems. This assay is intended to be used as an aid in the diagnosis of HIV infection and as a screening tool for blood and plasma donors.