WASHINGTON ? The Food and Drug Administration approved the first over-the-counter HIV test Tuesday, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes.
"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 a 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 test, manufactured by OraSure, already had been approved for medical clinics. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies beginning in October.
Tests for the human immunodeficiency virus, which causes AIDS, have become increasingly simpler and quicker to use since their introduction in the 1980s. In 2002, the FDA approved the first on-the-spot tests for clinics. In 2005, the FDA began exploring the possibility of approving a home test.
The FDA emphasized that any results from a self-administered test, which works by detecting antibodies in a swab from the gums, should not be considered final. In trials, the test failed to detect HIV in 1 in every 12 patients known to be infected, and returned false positives in 1 in 5,000 cases. Anyone receiving a positive result should follow up with a medical provider, the agency said.
In May, an FDA advisory panel unanimously recommended that the test be approved, saying the benefits outweighed the risks. One concern has been that people who learn that they are infected may not have immediate access to counseling or support.
The agency said it hoped the new tests would reach people who were not getting tested, which, in turn, could lead to early treatment and reduce the transmission rate of the virus.
Previously, the FDA approved an HIV home test, but the samples had to be sent to a laboratory for analysis.
The federal Centers for Disease Control and Prevention estimates that of the 1.2 million people in the U.S. with HIV, 1 in 5 is not aware of the infection. And it says that a disproportionate number of the 50,000 new cases of HIV each year is linked to people who have not been tested.
OraSure has not said how much the test will cost, only that it will be more than the $18 cost for the professional kit.
Kevin Frost, chief executive of the Acquired Immune Deficiency Syndrome research group amfAR, said although he thought home testing was a good idea, a high price tag could put it beyond the reach of those who needed it most.
"If the people who go out and pay for this test end up being sorority girls who had a one-night stand and worry if they're infected, that's not going to be a net positive," he said.
Doug Michels, president of OraSure, acknowledged that pricing was a "fine balance," but said his company's product was not designed to replace other options.
Chip Lewis, a spokesman for Whitman-Walker Health, which provides AIDS care in Washington, said at-home testing could reach some people who didn't want to go to a clinic. But removing medical professionals from the process could cause problems, he said.
"It's not like a home pregnancy test," he said. "You need really a lot of information about how to read the test, how to use the test properly."
Michels said OraSure's research showed that the vast majority of people receiving a positive result said they would seek medical advice. The FDA also required OraSure to run a call center to support users of the test. Michels said trained counselors would answer the calls.
ian.duncan@latimes.com
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