WEDNESDAY, SEPTEMBER 28, 2016

FDA approves test that detects HIV antibodies

The U.S. Food and Drug Administration announced on Thursday that is has approved the first rapid detection test for Human Immunodeficiency Virus.

The Alere Determine HIV-1/2 Ag/Ab Combo test is used to detect HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, venous and whole blood specimens. It is the first FDA-approved test that can distinguish between the results for HIV-1 p24 antigen and HIV antibodies in a single test. The test can also be used as an aid in the diagnosis of HIV-1 and HIV-2 infection.

"This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner," Karen Midthun, the director of the FDA's Center for Biologics Evaluation and Research, said. "Earlier diagnosis may also help to reduce additional HIV transmission."

With detection of the HIV-1 antigen, it is possible to have an earlier detection of the HIV-1 than is possible by testing for HIV-1 antibodies alone. The Alere test is able to distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.

The Alere Determine HIV-1/2 Ag/Ab Combo test is made by Orgenics, Ltd.