The U.S. Food and Drug Administration (FDA) today approved the first "rapid" HIV test that detects both HIV-1 p24 antigen and HIV-1 and HIV-2 antibodies. The "Alere Determine HIV-1/2 Ag/Ab Combo" test has been approved as an aid for the detection of HIV-1 and HIV-2, but is not intended to screen out blood donors.
The test was designed as a quick way to detect HIV-positive people in "outreach settings," such as kiosks or mobile clinics. It can also be a way for those not able to be traditionally tested to be screened for HIV.
The new test is also the only FDA-approved test to distinguish between HIV-1 p24 antigen and HIV antibodies through the same test. The detection of antigen means the test can determine a possible HIV infection just days after exposure. The HIV antibodies that other quick tests find take longer to build up in the body.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.”
HIV-1 is the most widespread version of HIV throughout the world. HIV-2 is primarily found in West Africa. The U.S. Centers for Disease Control and Prevention estimates that around 20% of people positive for HIV in the U.S. have not been diagnosed.
(Image courtesy Alere)