FDA News

FDA approves HIV infection type assay

The FDA has approved a diagnostic test able to specify HIV infection type from human serum or plasma specimens, according to a press release.

Manufactured by Bio-Rad Laboratories, the BioPlex 2200 HIV Ag-Ab assay is the first FDA-approved diagnostic able to differentiate between HIV-1 antibodies, HIV-2 antibodies and HIV-1 p24 antigen. The test is able to report these results separately, and is intended for use with the BioPlex 2200 System.

Karen Midthun

Karen Midthun

The BioPlex 2200 HIV Ag-Ab assay is intended for use in adults, children aged 2 years and older, and pregnant women. It can be used to screen organ donors for HIV-1 and HIV-2 when collected from a donor whose heart is beating, but is not approved for use in screening blood or plasma donors other than in urgent situations.

The FDA has approved a diagnostic test able to specify HIV infection type from human serum or plasma specimens, according to a press release.

Manufactured by Bio-Rad Laboratories, the BioPlex 2200 HIV Ag-Ab assay is the first FDA-approved diagnostic able to differentiate between HIV-1 antibodies, HIV-2 antibodies and HIV-1 p24 antigen. The test is able to report these results separately, and is intended for use with the BioPlex 2200 System.

“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 the 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.”

Karen Midthun

Karen Midthun

The BioPlex 2200 HIV Ag-Ab assay is intended for use in adults, children aged 2 years and older, and pregnant women. It can be used to screen organ donors for HIV-1 and HIV-2 when collected from a donor whose heart is beating, but is not approved for use in screening blood or plasma donors other than in urgent situations.