The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum and plasma. This kit is intended as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. This assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (ie. children as young as 2 years of age). The GS HIV Combo Ag/Ab EIA is intended for manual use and with the Bio-Rad EVOLIS™ Automated Microplate System.