FDA Approves First Assay That Differentiates HIV Types

Miriam E. Tucker


July 23, 2015

The US Food and Drug Administration (FDA) has approved the first-ever diagnostic test that differentiates between types of HIV infection.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay (Bio-Rad Laboratories, Inc, Hercules, California) distinguishes between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. It is intended for use with the BioPlex 2200 System, which was cleared by the FDA in 2004.

HIV-1 is the most commonly found type around the world. HIV-2 is found primarily in West Africa but has also been identified in the United States. The two viruses are similar, but distinct. Differentiating between the types is important for patient care because they progress at different rates, said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a news release.

The new assay allows results of antigen and antibody detection to be reported separately. Because HIV antigens and antibodies appear and are detectable at different stages of the infection, reporting of the distinct results helps differentiate between acute and established HIV infection, according to the FDA.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay can be used in adults, children aged 2 years or older, and pregnant women. It may also be used to screen organ donors for HIV-1/2 when the blood specimen is collected while the donor's heart is still beating. However, the assay is not approved for use in screening blood or plasma donors, except in urgent situations where traditional, licensed blood-donor screening methods can't be used.


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