Health News
2005-10-15
FDA considers
over-the-counter rapid HIV tests
An advisory panel
for the Food and Drug Administration is scheduled to
meet on November 3 to consider making the OraQuick rapid HIV
An advisory panel
for the Food and Drug Administration is scheduled to
meet on November 3 to consider making the OraQuick rapid HIV
antibody test available for over-the-counter purchase
and home use, The New York Times reports. The test,
called the OraQuick Advance Rapid HIV 1/2 Antibody
Test, can produce results in about 20 minutes from
oral samples. The tests are currently available only
to doctors, HIV clinics, and AIDS service organizations that
conduct street-level testing programs, but the FDA
panel is expected to recommend that they be available
directly to consumers.
The test is
simple to use, says developer OraSure Technologies. Users
swab their gums and place the swab in a holder. After 20
minutes, one line will appear on the holder if the
test is negative for HIV infection, and two lines if
the test result is positive. Its ease of use makes it
ideal for home use by adults who may be too nervous to seek
testing from their doctors or an HIV clinic or are
afraid of the stigma associated with possibly
receiving positive test results at a public testing
facility, proponents say. At-home testing also could help
identify the estimated one third of Americans who are
HIV-positive but unaware they’re infected.
But many AIDS
advocates and health officials say at-home testing could be
dangerous because there is no counseling component involved,
and those who test positive may panic and possibly
attempt suicide with no one there to talk with them
about their results and their options for treatment
and support.
OraSure president
Douglas Michels says the company would include any
FDA-recommended advice about counseling on the
product’s label—including referrals to a
24-hour counseling center, a hotline number, Internet
support, and printed material—if it were approved for
over-the-counter sales. (Advocate.com)
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