GAITHERSBURG, Md. -- An FDA advisory committee has voted 17-0 to recommend approval for the OraQuick In-Home HIV Test. If approved, it will be the first over-the-counter home HIV test.

About 2.8 million people would use the OraQuick In-Home HIV Test, made by OraSure Technologies, each year, an FDA reviewer estimated. The review projected that the home-use test would lead to 45,000 new positive test results and could avert more than 4,000 HIV transmissions in a year.

That would be the best-case scenario, said Blaine Hollinger, MD, chairman of the FDA's Blood Products Advisory Committee and professor of medicine, molecular virology, and epidemiology at Baylor College of Medicine in Houston.

But in order for the in-home test to have an effect on HIV infection rates, people who learn they are HIV-positive from the OraQuick test would have to change their behavior to prevent spread of the virus, Hollinger said.

The test isn't perfect, and in OraSure's clinical trials, there were eight individuals out of 5,558 who received a false negative result. So, if approved, OraQuick could lead to 3,800 false negative tests in people who wouldn't otherwise be tested, the FDA reviewer said.

In addition, the test could be expected to deliver one false positive test for every 3,750 true negative results, or approximately 1,100 false positive test results per year, according to briefing documents released ahead of Tuesday's meeting.

Panelists did not think the potential raised by inaccurate results were a reason not to approve the test. They especially hoped OraQuick will be used by high-risk people who wouldn't otherwise get tested.

OraSure said that a total 41% of those who used OraQuick in its clinical trial had never been tested for HIV previously. Of those who learned they were HIV-positive from the OraQuick test, 96% said they were highly likely to follow up with a doctor or clinic for treatment options, the company said.

For the OraQuick test, individuals swab their upper and lower gums, then insert the swab into a vial of test fluid. If the user has HIV, two colored lines develop on the test strip after 20 minutes. The information booklet in the package includes directions to call an OraQuick HIV support center -- reachable 24 hours a day, 7 days a week -- for counseling on the test results and referral to medical services.

A clinical trial of OraSure's test identified 106 previously undiagnosed people infected with HIV out of 5,558 individuals who used the product, according to OraSure's background documents.

The sensitivity of the test is 92.98% (95% CI 86.6% to 96.9%). The specificity of the test is 99.98% (95% CI 99.9% to 100%).

The sensitivity was much higher when the same testing kit was administered by a trained professional.

Some panelists expressed concern that individuals who currently get tested professionally may instead opt for the less sensitive but more private at-home test, but the panel ultimately voted 17-0 in a separate vote that the test is safe and effective.

HIV testing has evolved greatly over time. In the 1980s, testing always involved a clinical laboratory, pre-test counseling, posttest counseling, and medical referral. In the mid-1990s, the FDA approved two over-the-counter home-use blood collection kits for HIV testing. With those kits, the user mails in a blood sample and receives a result over the phone or by mail. Counseling and medical referral were also available by phone.

Starting in 2001, the FDA began approving a number of "rapid" HIV tests which are used by trained professionals and quickly deliver results in an outreach setting -- including the OraQuick test, offered in different packaging.

The OraQuick In-home HIV test would be the first to deliver results at home, in much the way a home pregnancy test does.

During Tuesday's meeting, the panel heard testimony from dozens of HIV patients and public health advocates urging the panel to recommend approval for OraQuick.

If marketed, the test would likely be sold in a similar manner to some cough medicines, according to a company spokesman. At checkout, the cashier would ask to see the purchaser's ID to confirm he or she is at least 17.