May 15, 2012
The Food and Drug Administration (FDA)'s Blood Products Advisory Committee meets today to consider whether to recommend approval of an over-the-counter HIV test. Many public health experts believe at-home HIV testing could help reduce the number of Americans who are infected but unaware. An estimated 50 percent to 70 percent of the more than 50,000 new U.S. HIV cases annually are transmitted by these individuals.
The panel is considering OraSure Technologies Inc.'s OraQuick Advance Rapid HIV-1/2 Antibody Test, which is already used by clinics worldwide. The test subject's gums are swabbed with a pad that then is placed in a vial of fluid for 20 minutes. Similar to home pregnancy tests, the appearance of two lines on the device indicates HIV. A follow-up blood test is needed to confirm infection.
In a clinical trial of more than 5,000 people at 20 U.S. sites, the test found 106 previously undiagnosed HIV cases. It was 99 percent accurate, with one false-positive and eight false-negatives. Sixty people could not use the test for reasons that included spilling liquid (five), inability to read instructions (four) or inability to comprehend results (10).
Professionals currently counsel people taking HIV tests about prevention and treatment options, and they provide emotional support. However, none of that is guaranteed with home testing. OraSure says it will provide 24-hour live support via a toll-free call center, which would refer people to counseling.
The committee will consider the issue of counseling and whether consumers can follow test instructions and get accurate results. Its recommendation will be submitted to the agency for a decision; FDA usually follows its advisors' guidance, though it is not required to.
05.15.2012; Don Sapatkin
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