FDA approves rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies

The U.S. Food and Drug Administration has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test also independently distinguishes results for HIV-1 p24 antigen and HIV antibodies.

The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional healthcare settings. It does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.

Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but negative for HIV-1 and HIV-2 antibodies.

“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” says Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.” Learn more about this test from its manufacturer.