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FDA Approves First At-Home HIV Test
Experts say it could reduce the number of Americans who are unaware of their HIV status
By Randy Dotinga
HealthDay Reporter
TUESDAY, July 3 (HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved the first do-it-yourself HIV test that would give people their results in the privacy of their own home.
The test, called OraQuick(R) In-Home HIV Test, involves swabbing the gums, placing the swab into a vial, and then seeing the results within 20 minutes, the agency said in a statement.
The test kit's approval could herald a new era in HIV prevention, experts say. According to the CDC, more than 1.2 million Americans carry the virus that causes AIDS, but about one in five are unaware that they are infected and can pass HIV on to others.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."
The move comes two months after a 17-member FDA advisory panel voted unanimously that the benefits of the test were greater than any possible risks.
OraSure Technologies Inc., which makes the over-the-counter test, already sells a version of it to doctors and other health professionals. Studies have shown the test was less accurate when used by consumers, but the FDA advisory panel agreed that the benefits of expanding HIV testing still outweighed a small drop in test accuracy.
Speaking just after the test got the nod from the advisory panel in March, Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University, said that "there is huge global momentum in support of over-the-counter testing for HIV. People desire private, discrete options that protect their confidentiality." Pai co-authored an analysis of the effectiveness of an at-home HIV test earlier this year.
