The Genetic Systems HIV-1/HIV-2 Plus O EIA has been FDAapproved as a diagnostic tool to detect HIV-1 (Groups M and O) and HIV-2. The Centers for Disease Control and Prevention (CDC) published the first US case of HIV-1 Group O infection discovered in Los Angeles in 1996. From 1996 to 1997, the FDA notified licensed test manufacturers to incorporate a Group Oderived antigen in HIV test kits to enhance detection of the HIV-Group O variant.
The Genetic Systems HIV-1/HIV-2 Plus O EIA assay can be used with serum or plasma samples in both screening and diagnostic laboratories. Clinical data reflect 100% sensitivity verified by testing HIV-2, HIV-1, and HIV-1 Group O positive samples and 98.89% specificity tested with normal donor samples. This new assay will support the goals of the CDC by closing the serological window in the detection of HIV-1 (Groups M and O)/HIV-2.