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The Food and Drug Administration
(FDA) approved a new home HIV test on July 3 that makes it possible for people
to test themselves in the privacy of their homes. The availability of an HIV
test that’s as easy to use as a home pregnancy test could be another step in
the direction of reducing stigma associated with the disease and increasing the
number of people who know their HIV status.
Dr. Anthony S. Fauci, longtime AIDS
researcher and director of the National Institute of Allergy and Infectious
Diseases (NIAID), called the new test a “positive step forward” and one that
could help bring the 30-year-old epidemic under control.
Studies have shown that getting
HIV-positive people onto antiretroviral drug therapy lowers the chance that
they will transmit the virus to someone else by as much as 96%. Testing and
treatment have therefore become crucial to prevention and are part of the
National HIV/AIDS strategy, though questions remain as to how to guarantee
access to care and treatment for those who test positive.
The OraQuick test, by OraSure
Technologies, uses a mouth swab and gives results in 20 to 40 minutes. A
previous test sold over the counter required the user to prick a finger and
mail a drop of dried blood to a lab, thus making it days before results were
known.
The new test has some drawbacks.
While it is extremely accurate when administered by medical professionals, it
is less so when used by consumers. Researchers found the home test to be
accurate 99.98% of the time for people who do not have the virus. By
comparison, they found it to be accurate 92% percent of the time in detecting
people who do. So, while only about one person in 5,000 would get a false positive
test, about one person in 12 could get a false negative.
One concern is the “window period”
between the time someone gets the virus and begins to develop the HIV
antibodies that the test detects. That can take up to three months.
Any positive test needs confirmation
in a doctor’s office, the FDA said, and people engaged in high-risk sex should
test themselves regularly.
The agency does not intend for the
home test to replace medical testing, but instead to provide another way for
people to find out their HIV status, said Dr. Karen Midthun, director of the
FDA’s Center for Biologics Evaluation and Research.
Of concern to those who work as
testers in AIDS service organizations is the issue of pre- and post-test
counseling, especially for those who test positive. “My main concern is that
anyone who got a positive result might harm themselves,” says Derek Worley, a
tester and member of the Prevention Department at Test Positive Aware Network.
“Finding out you’re positive can be a traumatic event, even if a trained
counselor is there with you. I can’t imagine it would be any easier if you’re
alone,” he added.
OraSure intends to set up a
toll-free, 24-hour phone line to provide answers to questions and guidance to
those who test positive about how to connect with care and service providers.
The home test should be available in 30,000
pharmacies, grocery stores, and online retailers by October, said Douglas
Michels, OraSure’s chief executive. The price has not yet been set, but he said
it would be higher than the $17.50 now charged to medical professionals because
the company will do more complicated packaging for the home kit, open the
24-hour hotline, and advertise to high-risk groups, including gay men, blacks
and Hispanics, and sexually active adults. Still, he said, it will be kept
inexpensive enough to appeal to people who might want to buy several a year. In
addition, because the FDA approved the home test only for people 17 and older,
retail stores may ask customers to show ID.
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!
