OraSure Technologies Inc.
The Federal Food and Drug Administration has approved the OraQuick In-Home HIV Test, the first at-home, quick test for HIV antibodies.
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Federal health officials have approved the first at-home test for antibodies against HIV, a step that aims to identify and treat the estimated 20 percent of infected people in the United States, who do not 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 quickly detects possible HIV infection. Despite worries about learning serious diagnosis at home an FDA panel unanimously agreed that the benefits outweigh risks. home test "It is very exciting," said Carl Schmid, Deputy Executive Director of the AIDS Institute, a non-profit that focuses on issues surrounding the disease. "It could be a potential game-changer for HIV."
Manufactured by OraSure Technologies Inc. of Bethlehem, PA., user test swabs of oral fluids from the upper and lower gums, which are then tested for the presence of antibodies to human immunodeficiency virus type 1 and type 2, HIV-1, HIV-2. Test results are available within 20 to 40 minutes.
A positive result does not mean that the person who is definitely infected with HIV, but rather to further should the test be performed by medical professionals to confirm the result. A negative result does not mean that a person is absolutely clear of the virus, especially if exposure may have occurred in the previous three months. OraSure expects the at-home HIV test should be available in October starting at more than 30,000 retail stores across the United States and online, according to a company press release. A spokeswoman said
would set fixed prices for the test 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 United States are living with HIV infection. About one of every five do not know they are infected. About 50,000 new HIV infections are diagnosed each year. The test is about 92 percent accurate correctly identify positive results, a measure known as sensitivity, clinical trials showed. This means that one false negative results could be expected from all 12 tests.
It was also around 99,98 per cent accurate correctly identify negative results, a measure known as specificity. This means a false positive would be expected 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 to understand the results of the tests.
Doug Michels, OraSure CEO, discusses the benefits of the first FDA-approved home HIV test. It will begin to sell to retailers in October for less than $ 60 per kit.
