This product is based on the ELISA sandwich principle, utilizing highly specific antigen–antibody combinations to simultaneously detect HIV-1/2 antibodies and the HIV-1 p24 antigen. In the 96-well microplate, antibodies and antigens are immobilized as the solid phase, while purified peroxidase-conjugated components serve as the detection phase. This design minimizes cross-reactivity and reduces false positives, ensuring high sensitivity and reliability. GB HIV Ag-Ab COMB assay is a manual 4th generation solid phase Enzyme-Linked Immunosorbent assay using a mixture of antigens and antibodies for the qualitative in vitro diagnostic screening in human serum or plasma (EDTA, Heparin, and Citrate) of antibodies to HIV-1 (group M and O), HIV-2 and HIV-1 p24 antigen. The device is for professional use only. GB HIV Ag-Ab COMB assay is intended to be used as a screening test for donated blood to prevent transmission of HIV-1/HIV-2 to recipients of blood and blood components. GB HIV Ag-Ab COMB assay is not intended to screen and diagnose acute or primary HIV infection. GB HIV Ag-Ab COMB assay result does not distinguish between the detection of HIV-1 antibody, HIV-2 antibody, or HIV-1 p24 antigen and is not for diagnostic use.