May 15, 2012 -- The FDA should approve the first HIV test for at-home use and over-the-counter sale, the agency's advisory committee said today in a unanimous 17-0 vote.
The test is OraQuick from OraSure. It's a home version of a rapid HIV test already being used by health care professionals in community settings.
The committee's opinion was summed up by panel member Steven W. Pipe, MD, of the University of Michigan.
"I can't get past the quarter of a million people in the U.S. who have HIV and are not tested," Pipe said at the meeting. "If we make any dent in that, the answer is yes, we realize the [OraQuick At-Home] benefit outweighs its risks."
The price tag of the at-home test has not yet been set but will be a good bit more than the $20 cost of the professional version. That's partly because it will come with a detailed instruction booklet, and because OraSure will set up a call center with trained counselors available 24 hours a day, seven days a week.
"The price will be substantially lower than $60," Stephen R. Lee, PhD, OraSure executive vice president and chief science officer, told the committee.
Now anybody concerned about whether they have the AIDS virus -- and who can afford OraQuick -- may be able to take the test at home. But there's a catch.
In clinical trials enrolling regular people at risk of HIV infection, some 7% of people with HIV infection are wrongly told they don't have HIV. With a professional test, that happens only 2% of the time.
According to FDA calculations, this means that in the first year after approval, the test will wrongly tell about 3,800 people with HIV infection that they are not infected.
The FDA calculates that in the first year after OraQuick is approved for home use, an extra 45,000 people will correctly learn they have HIV.
That's a big deal. The CDC estimates that there are 50,000 new HIV infections every year. About 1.2 million Americans are HIV-infected, and about 1 out of 5 don't know they carry the AIDS virus. Such people may be more likely to spread the virus than those who know they are infected.
Panel member Susan Buchbinder, MD, director of HIV research at San Francisco's health department and a long-time AIDS researcher, noted that while some people may get inaccurate results, the test likely will alter people's HIV risk behavior.
"A positive HIV test does reduce risk behavior. A negative test doesn't have much of an influence," Buchbinder said. "We must assume there will be some incorrect results. The question is how do we help people understand a negative result might not truly mean a person is negative for HIV."
There's another catch to the OraQuick in-home test: the "window period." The test detects anti-HIV antibodies, but these antibodies appear many weeks after infection.
A recent study suggests that rapid HIV tests such as OraQuick will be accurate two months after infection. OraSure says that to be safe, people should assume the OraQuick test will miss any new HIV infection contracted in the past three months.
This means that people with any HIV risk behavior -- such as unprotected sex or needle sharing -- will need regular retesting, as is true with any HIV test. And confirmatory testing at a doctor's office or free clinic is strongly advised for those who test positive but also for those who test negative despite high-risk behavior.
Is America Ready for Home HIV Testing?
HIV testing has been controversial ever since it began in 1985. In those days, before HIV drugs were developed for treatment, a positive test result was considered a death sentence.
Stigma was enormous. Children with HIV were kicked out of school. Adults with HIV lost their jobs. It took great courage for a person with HIV to tell anyone about it.
And because a positive test had such a dramatic impact, HIV testing was done only along with counseling, both before and after the result was known.
While these safeguards were necessary, they threw up barriers to testing. The hassle is one reason why so many people at risk of HIV infection never get tested -- or don't get regular HIV tests.
In 1989 and again in 1990, the FDA was approached by companies that wanted to sell HIV tests over the counter. But according to an FDA briefing document, "the state of technology and public-health thinking at that time was not conducive to such a claim."
In other words, America wasn't ready for a home HIV test. But in 1996, the FDA approved two kits that allowed people to gather blood or mouth-swab samples and send them off to a lab for testing. Test results, counseling, and referral to medical care were available by phone.
These tests did not have much of an impact on HIV testing by people at risk of infection. So the FDA was happy to listen to OraSure when the company suggested it could expand access to testing with an at-home test.
The result, after three rounds of ever-more-realistic testing, was still not a slam dunk. Concerned that the test might falsely assure too many people with HIV that they were not infected, the FDA asked today's expert panel to consider all the issues involved.
The panel's unanimous vote today suggests that the U.S. has entered a new era of HIV testing.