(HealthDay News) — A new diagnostic to differentiate between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens has been approved by the U.S. Food and Drug Administration.
The Bio-Rad BioPlex 2200 HIV Ag-Ab assay is approved for people aged two years and older, including pregnant women. The test can be used to screen organ donors for the two major types of HIV (HIV-1 and HIV-2), but it’s not been approved to routinely screen donated blood or plasma for the virus, the agency said.
While cases of HIV-2 have been diagnosed in the United States, HIV-2 has been found primarily in West Africa, the FDA said. Most cases in the United States have been linked to HIV-1. The viruses are similar yet distinct.
“Today’s approval provides health care professionals another option for the diagnosis of HIV infections,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
The new diagnostic is produced by Bio-Rad Laboratories, based in Hercules, CA.