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FDA Gives Nod to First Diagnostic Test That Differentiates Types of HIV Infection

Assay allows results of antigen and antibody detection to be reported separately

The FDA has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay (Bio-Rad Laboratories), the first agency-approved diagnostic that differentiates human immunodeficiency virus (HIV)-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.

Two major types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been identified in the U.S. HIV-1 and HIV-2 are similar but distinct viruses.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay was designed to aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute HIV-1 infection. The test may be used in adults, in children 2 years of age and older, and in 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 tests are unavailable or their use is impractical.

“Today’s approval provides health care professionals another option for the diagnosis of HIV infections,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The ability to diagnose HIV infection early and to differentiate between types of infection is important in the care of individuals as both diseases exhibit the same symptoms but progress at different rates.”

HIV antigens and antibodies are detectable at different stages of the infection. Early in the infection, HIV-1 antigen can be detected before the development of detectable levels of HIV-1 antibodies. Acute HIV-1 infection is identified when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.

The Bio-Rad BioPlex 2200 HIV Ag-Ab assay allows results of antigen and antibody detection to be reported separately. In addition to distinguishing between established HIV-1 and HIV-2 infection, reporting of distinct results helps differentiate between acute and established HIV infection, respectively.

The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System, which was cleared by the FDA in 2004.

Source: FDA; July 23, 2015.

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