The nation's first over-the-counter, rapid in-home HIV test could be available soon. A Food and Drug Administration panel of independent experts has unanimously voted that OraSure Technologies' rapid test is reasonably safe and effective for determining whether someone is someone is HIV positive, reports BusinessWeek.
The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing.
Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
The rapid home test could have dramatic potential in the Black community and particularly among Black men who have sex with men (MSM). African Americans make up some 56 percent of all so-called late testers--people who are diagnosed with AIDS within one year of their HIV diagnosis. Not only do late testers have less chance to benefit from lifesaving ARVs, but they are "considered extremely infectious, because they typically have massive amounts of the virus" in their bodies, reports the Wall Street Journal. The sooner the person is treated after diagnosis, the less likely he or she is to infect others.
Young Black MSM aged 13 and 29 have suffered the most, with new infection rates soaring by over 48 percent. See our recent print/digital series "Reversing the Alarming HIV Increase Among Black Gay Men Part 1" and "Part 2"
Those testifying in favor of the in-home OraQuick test included a number of experts on HIV/AIDS in Black communities, reports AIDSMeds.
Public testimony at the hearing was overwhelmingly favorable. Roughly 20 agency representatives—including Phill Wilson of the Black AIDS Institute, Cornelius Baker of the Whitman-Walker Clinic in Washington, DC, Dawn Averitt-Bridge of The Well Project, Larry Bryant of Housing Works, C. Virginia Fields of the National Black Leadership Commission on AIDS and Ernest Hopkins of the San Francisco AIDS Foundation—testified that the Oraquick In-Home HIV Test would be a welcome addition to the HIV testing and awareness tool box, particularly for women and people of color living with, and at risk for, HIV who are not being effectively connected to existing testing programs.
The FDA will make its final decision on whether to approve the product later this year.