This in vitro diagnostic ELISA assay is designed for qualitative detection of antibodies to HIV-1 and/or HIV-2 in human serum or plasma. The test uses a direct sandwich ELISA format with a 96-well microplate, a specimen volume of 50 µL, and an incubation time of 90 minutes, read at 450 nm. Certified by TFDA (Taiwan), it provides reliable HIV antibody screening. A Non-Reactive result indicates no detectable HIV-1/2 antibodies; Reactive indicates presence of antibodies and should be interpreted with clinical correlation.