Bio-Rad Laboratories has submitted a pre-market approval application to the US Food and Drug Administration for its fourth-generation GS HIV Combo Ag/Ab EIA (enzyme immunoassay) HIV assay.
The GS HIV Combo Ag/Ab EIA detects HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection), offering early detection of HIV infections as well as acute HIV infections.
Clinical studies were performed at five major institutions in the US on a large sample population including adult and paediatric patients with HIV infections, individuals in high- and low-risk groups, and pregnant women.
The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay used for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma.
The assay is intended to be used as an aid in the diagnosis of infection with HIV-1 and HIV-2.
