FDA Panel Backs At-Home HIV Test

TUESDAY, May 15 (HealthDay News) —
A U.S. Food and Drug Administration advisory panel recommended Tuesday
approval of the first HIV test that would give people the results in the
privacy of their own home.

The 17 panel members were unanimous in voting that the benefits of the
test were greater than any possible risks. The test kit, known as
Oraquick, detects the presence of HIV — the virus that causes AIDS —
within 20 minutes, the Associated Press reported.

If the FDA heeds the recommendation of its advisory panel, the decision
could pave the way toward a new era in HIV testing. The agency typically
follows the recommendations of its advisory groups.

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 panelists said Tuesday that the benefits of expanding HIV testing
outweigh a small drop in test accuracy, according to the AP.

“There is huge global momentum in support of over-the-counter testing
for HIV. People desire private, discreet options that protect their
confidentiality,” said Dr. Nitika Pant Pai, an assistant professor of
medicine at Montreal’s McGill University who co-authored an analysis of
the effectiveness of an at-home HIV test earlier this year.

The test, which looks for signs of HIV in oral fluid, is already used
at hospitals and doctors’ offices where medical professionals administer
it. The FDA first approved its use in 2004.

To take the OraQuick test, people swab their outer gums and put the
swab into a vial. After about 20 minutes, the test device will reveal two
reddish-purple lines in a small window if there are signs that the body’s
immune system has geared up to battle HIV.

The test uses oral fluid, which is not the same as saliva. Its results
are considered preliminary, and should be confirmed by a blood test.

OraSure had nearly 5,700 people take the at-home version of the test.
The tests found that 114 thought they were HIV-positive; 106 of them
actually were. That means that positive results were accurate 93 percent
of the time. Negative results were accurate 99.98 percent of the time, the
company said.

Pant Pai said the oral test‘s overall accuracy is similar to that of a
blood test, although it’s slightly less accurate. The oral test, in
particular, may miss HIV infection in its early stages, she said.

Also, “the sensitivity of the test appears lower when administered in
the home setting rather than a medical setting, so some of the people who
are HIV-positive will get a test result that they are negative,” said Jane
Rotheram-Borus, director of the Center for HIV Identification Prevention
Treatment Services at the University of California, Los Angeles.
“However, if they would otherwise not have gotten the test at all, they
may also have believed they were negative.”

Experts have expressed concern for people who learn at home, possibly
alone, that they are probably infected with the virus that causes
AIDS.

“The arguments against the at-home test focus on the absence of a
counselor who could provide support and link the newly identified
HIV-positive individual to medical care,” said Rotheram-Borus, who
supports over-the-counter sales of the OraQuick test.

She pointed out that “over-the-counter pregnancy tests are widely used,
and pregnant women do find their way into prenatal care.”

Orasure has said it will offer a 24-hour toll-free number that people
can call to get support regarding their test results.

The comnpany has not determined the over-the-counter price of the test
yet.

More information

For more on HIV and AIDS, try the U.S. National Library of
Medicine.

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