OraSure Technologies Inc.
The federal Food and Drug Administration has approved the OraQuick In-Home HIV Test, the first at-home, rapid test for HIV antibodies.
Federal health officials have approved the first at-home test to detect HIV antibodies, a move aimed at identifying and treating the estimated 20 percent of infected people in the U.S. who don’t know they have the virus that causes AIDS.
Food and Drug Administration officials on Tuesday approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered test that rapidly detects possible HIV infection. Despite concerns about learning of the serious diagnosis at home, an FDA panel unanimously agreed that the benefits of the home test outweigh the risks.
"It's extremely exciting," said Carl Schmid, deputy executive director of the AIDS Institute, a nonprofit that focuses on issues surrounding the disease. "It could be a potential game-changer for HIV."
Manufactured by OraSure Technologies Inc. of Bethlehem, Pa., the test uses swabs of oral fluids from the upper and lower gums, which are then tested for presence of antibodies to the human immunodeficiency virus type 1, HIV-1, and type 2, HIV-2.
Test results are available within 20 to 40 minutes.
A positive result does not mean that the person is definitely infected with HIV, but rather that additional testing should be done by medical professionals to confirm the result. Similarly, a negative test result does not mean that a person is definitely clear of the virus, particularly if exposure may have taken place within the previous three months.
OraSure expects the at-home HIV test to be available starting in October at more than 30,000 retail outlets across the U.S. and online, according to a company press release. A spokeswoman said firm prices for the test will be determined closer to distribution.
The test has the potential to identify large numbers of previously undiagnosed HIV infections. An estimated 1.2 million people in the U.S. are living with HIV infection. About one of every five don’t know they’re infected. About 50,000 new HIV infections are diagnosed every year.
The test is about 92 percent accurate in correctly identifying positive results, a measure known as sensitivity, clinical trials showed. That means that one false negative test result could be expected out of every 12 tests.
It was also about 99.98 percent accurate at correctly identifying negative results, a measure known as specificity. That means one false positive would be expected out of every 5,000 test results in uninfected individuals.
OraQuick plans to offer consumers access to toll-free 24-hour support center to help consumers understand the results of the tests.
Doug Michels, OraSure CEO, discusses the benefits of the first FDA-approved home HIV test. It will begin selling at retailers in October for less than $60 per kit.
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The FDA has approved the first over-the-counter HIV test kit. NBC's Brian Mooar reports.