FDA Panel to Consider At-Home HIV Test

TUESDAY, May 15 (HealthDay News) — Should Americans be able to
buy a test at the drugstore and use it to determine whether they’re
infected with the virus that causes AIDS?

A U.S. Food and Drug Administration advisory panel plans to debate this
question Tuesday, and the answer the panel arrives at could pave the way
toward a new era in HIV testing.

FDA advisory panel recommendations are not binding, but they are often
followed by the agency.

“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 test, known as OraQuick, patients 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.

At its meeting this week, the panel is expected to discuss the fact
that the test is not as accurate as HIV blood tests.

OraSure, the company that manufactures OraQuick, 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.”

In addition to talking about its accuracy, the FDA panel may also
examine the support that’s available 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.”

The company that makes the test says it will offer a 24-hour toll-free
number that people can call to get support regarding their test
results.

OraQuick 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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