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The U.S. Food and Drug Administration on Tuesday approved the first do-it-yourself HIV test that would give people their results in the privacy of their own home.
The test, called OraQuick(R) In-Home HIV Test, involves swabbing the gums, placing the swab into a vial, and then seeing the results within 20 minutes, the agency said in a statement.
The test kit's approval could herald a new era in HIV prevention, experts say. According to the CDC, more than 1.2 million Americans carry the virus that causes AIDS, but about one in five are unaware that they are infected and can pass HIV on to others.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."
The move comes two months after a 17-member FDA advisory panel voted unanimously that the benefits of the test were greater than any possible risks.
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 FDA advisory panel agreed that the benefits of expanding HIV testing still outweighed a small drop in test accuracy.
Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University, said that "by making self tests available over the counter, a stigmatized HIV diagnosis will be normalized to some extent."
She added that, "individuals are not averse to the test, but to the process of testing. With an oral test that is convenient, noninvasive and highly accurate in the hands of a trained user and fairly accurate in the hands of an untrained user, individuals will be motivated to seek testing." Pai 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 that 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 stage. "Self test will be a first step -- you will always need confirmation of a preliminary HIV diagnosis," 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," Jane Rotheram-Borus, director of the Center for HIV Identification Prevention & Treatment Services at the University of California, Los Angeles, said in May. "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."
In a news release issued Tuesday, Orasure said it expects that the OraQuick test will become available in October at more than 30,000 retail outlets nationwide, as well as online. Orasure has also said that it will offer a 24-hour, toll-free number that people can call to get support regarding their test results.
For more on HIV and AIDS, try the U.S. National Library of Medicine.