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FDA approves test for detection of HIV-1 antigen, HIV-1/2 antibodies
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The FDA today approved the first rapid HIV test for detection of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens, according to a press release.
The Alere Determine HIV-1/2 Ag/Ab Combo Test (Orgenics, Ltd.) is approved to aid in the diagnosis of HIV-1 and HIV-2 and is the first FDA-approved test capable of distinguishing results for HIV-1 p24 antigen and HIV antibodies in a single test.
The test can differentiate between acute HIV-1 infection and established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but negative for HIV-1 and HIV-2 antibodies. The test cannot distinguish, however, between HIV-1 and HIV-2 antibodies and is not intended for use in screening of blood donors.
Karen Midthun
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “Earlier diagnosis may also help to reduce additional HIV transmission.”