Bio-Rad Laboratories has received premarket application approval from the US Food and Drug Administration for its fourth-generation HIV assay, the GS HIV Combo Ag/Ab EIA (enzyme immunoassay).
The GS HIV Combo Ag/Ab EIA detects HIV antigens and HIV antibodies, offering early detection of HIV infections, including acute HIV infections.
Clinical studies were performed at five major institutions in the US on a large sample population, including adult and pediatric patients in high- and low-risk populations.
The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum or plasma.
The kit is intended to be used as an aid in the diagnosis of infection of HIV-1 and/or HIV-2 in adults and children as young as two years of age.
The kit can run on Bio-Rad's Evolis system, a self-contained automated microplate processor, and the kits may also be used with manual testing systems.