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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 US 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 US 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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
