Diagnostic Test That Can Distinguish Between HIV Infection Types Approved

The US Food and Drug Administration today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first ever FDA-approved diagnostic capable of differentiating among HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigens in human or plasma serums or specimens.

The US Food and Drug Administration (FDA) today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first ever FDA-approved diagnostic capable of differentiating among HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigens in human or plasma serums or specimens.

While HIV-1 and HIV-2 appear similar, they have distinct features — namely HIV-1 is the primary culprit for most of the HIV infections on a global level, whereas HIV-2 is found mainly in West Africa.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay could be used in adults, children two years and older, and pregnant women to help diagnose HIV-1, HIV-2, and acute HIV-1 infections. During the early stages of infection, HIV-1 antigen could be located prior to the full development of certain HIV-1 antibodies.

Furthermore, the assay could potentially be beneficial in screening organ donors for HIV-1 or 2. Researchers stress the assay is not yet approved to aid in the screening of blood or plasma donors, except in urgent situations.

The BioPlex 2200 HIV Ag-Ab assay is intended to be used with the BioPlex 2200 System, which had already been granted FDA clearance in 2004.

Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, remarked in a news release, “The ability to diagnose HIV infection early and differentiate between types of infection is important in the care of individuals as both diseases exhibit the same symptoms but progress at different rates.”