FRIDAY, July 24, 2015 (HealthDay News) — A new diagnostic to differentiate between strains of the AIDS-causing virus has been approved by the U.S. Food and Drug Administration.
The Bio-Rad BioPlex 2200 HIV Ag-Ab assay can distinguish between HIV-1 and HIV-2, the FDA said in a news release. The diagnostic is approved for people aged two years and older, including pregnant women.
The test can be used to screen organ donors for either strain of the HIV virus, 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.
The new diagnostic is produced by Bio-Rad Laboratories, based in Hercules, Calif.
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