FDA Approves First Test to Distinguish HIV Types

Test distinguishes between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.

The first diagnostic test that can differentiate between types of HIV infection has been approved by the FDA.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens, according to the FDA. The test may be used in adults, children aged ≥2 years, and pregnant women, and it will also help screen organ donors for HIV-1/2 when a blood specimen is collected, while the donor’s heart is still beating.

However, the assay is not intended for screening blood or plasma donors, “except in urgent situations,” the FDA stated. In addition, the assay will allow health care professionals to detect antigen and antibody separately, and it will help differentiate between acute and established HIV infection.

“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 press 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.”

Most patients in the United States who are infected with HIV have HIV-1, while HIV-2 is more often found in West Africa. However, HIV-2 infections have been identified in the United States, as well.