About AIDS
Will FDA approve rapid test for home use?
By Sandy Bartlett, Fri., Nov. 4, 2005
OraSure Technologies has submitted a proposal to the FDA to make their oral-specimen, rapid HIV test available for home use through over-the-counter sales. The proposal starts review this week.
Last year, OraSure introduced their OraQuick Advance HIV-antibody test that uses oral fluids, not blood, and provides results in 20 minutes. So far, it is only approved for test sites and medical providers.
Using the OraQuick Advance test is easy: Oral fluids are collected with a swab, which is then placed in a tube for 20 minutes with a test-reaction strip; the strip will show if the sample is positive for HIV antibodies. It is just as accurate as lab-based tests. Obviously counseling resources will be important, especially for those who come up HIV-positive, so significant scrutiny will be given to OraSures counseling component in the proposal.
Many HIV/AIDS experts see major usefulness in easy, at-home testing. They believe it would help get poz people into care earlier and would lead people to change to behaviors with less risk, whether for themselves or their partners. In particular, at-home testing would address the more than 250,000 Americans who have HIV and dont know it; and the more than 8,000 people each year who test positive for HIV but dont come back for their results.
No one knows if FDA will approve OraSures proposal or even if consumers would buy enough test kits to make the product profitable. Nonetheless it is clear that more options are becoming available as we continue our battle against HIV/AIDS.
Remember ASAs Dining With the Expert on Nov. 10. Dwayne Haught, manager of the Texas HIV Medications Program (ADAP), will explain the coming changes in how people will get their meds through Medicare, Medicaid, and ADAP. Dinner begins at 6pm. ASA is located at 7215 Cameron, just north of St. Johns. Please call the receptionist at 458-2437 or e-mail [email protected] to reserve your place.
