FDA OKs First Rapid Test for HIV-1/2 Antibodies, HIV-1 Antigen

August 08, 2013

The US Food and Drug Administration (FDA) today approved the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen. The new test will enable HIV testing to expand to regions without traditional healthcare facilities and speed up treatment, according to the agency.

The Alere Determine HIV-1/2 Ag/Ab Combo test, manufactured by Orgenics of Yavne, Israel, can detect HIV antibodies and the HIV-1 p24 antigen in human serum, plasma, and venous or fingerstick whole-blood specimens. The HIV-1 antigen is an earlier tip-off to HIV-1 infection than HIV-1 antibodies by themselves. The new test can tell the difference between acute vs established HIV-1 infections when the blood specimen tests positive for the p24 antigen, but negative for HIV-1 and HIV-2 antibodies.

Most HIV infections worldwide stem from HIV-1. HIV-2 infections occur mostly in West Africa.

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

The Alere Determine HIV-1/2 Ag/Ab Combo test is not intended to screen blood donors.

More information on the FDA approval of the new HIV test is available on the agency's Web site.


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