Is an authoritative, single-use, rapid diagnostic assay widely utilized globally for detecting HIV-1 and HIV-2 antibodies. Renowned for its 99.76% clinical sensitivity and 99.85% specificity, it serves as a critical point-of-care medical device that delivers clear visual results within approximately 10 to 20 minutes. Because it is a third-generation test detecting early-stage IgM antibodies, it reduces the window period compared to older testing models.