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 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 stressed 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 one 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 outweigh the risks. One concern has been that people who learn they are infected may not have immediate access to counseling or support.
The agency said it hopes the new tests will reach people who are currently not getting tested.
Previously, the FDA had 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 United States with HIV, one in five is not aware of the infection. And it says that a disproportionate number of the 50,000 new cases of HIV each year are linked to people who have not been tested.
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