Commentary & Opinion
FDA Should "Swiftly" Approve Over-the-Counter HIV Test Once Application Submitted, Editorial Says
November 21, 2005
FDA "should swiftly certify a home-use test" for HIV once such an application is submitted and the product is deemed "reliable and appropriate for use by untrained people," a New York Times editorial says. No manufacturers have filed an application with FDA for an at-home HIV test, but the agency recently conducted exploratory hearings that suggest a company might soon file for approval, the editorial says (New York Times, 11/19). An FDA advisory committee earlier this month heard testimony on a proposal to allow consumers to use OraSure Technologies' OraQuick Advance Rapid HIV 1/2 Antibody Test at home. The test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the result is negative and two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 11/8). About one-fourth of HIV-positive people in the U.S. do not know they are infected, and about one-third of people who test for HIV using standard methods, which take two weeks to process, never return to the clinic to retrieve their results, the editorial says, adding that an over-the-counter HIV test is the "ideal tool for reaching" those people (New York Times, 11/19).
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.