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The first over-the-counter rapid HIV
test has received Food and Drug Administration approval. The OraQuick test
detects the presence of HIV in saliva collected by an oral swab, with results
ready in 20 to 40 minutes. FDA officials said it is targeted toward people who
might not otherwise seek HIV screening, allowing them to test in the privacy of
their homes.
“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,” said Dr. Karen Midthun, director of FDA’s
Center for Biologics Evaluation and Research.
However, the agency stressed that
the OraQuick home test is only 92 percent accurate in detecting HIV among those
who have the virus, meaning one person for every 12 HIV-positive people using
it could be missed. OraQuick is 99 percent accurate in ruling out HIV in people
who are uninfected, meaning it would incorrectly identify one patient as
HIV-positive for every 5,000 HIV-negative people tested.
OraQuick, made by Bethlehem,
Pa.-based OraSure, has been used in clinical settings since 2002. When used by
doctors, nurses and other trained practitioners, the test is 99 percent
accurate in identifying the virus in carriers and non-carriers. It is not known
why OraQuick appears less accurate in consumer trials, though company
researchers said they anticipated its specificity would decline when used by
consumers versus professionals.
OraSure says it will likely start
selling OraQuick in October through retailers like CVS, Walgreens, and Walmart,
and online pharmacies. The home test will be priced at less than $60, compared
to the $17.50 cost for health care professionals. CEO Doug Michels said the
difference helps pay for a bi-lingual, toll-free call center that will provide
users with counseling and medical referrals.
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!
