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FDA Approves New Rapid HIV Test

The test, called OraQuick and made by OraSure Technologies Inc., has 99.6 percent accuracy and is simple to use, according to the FDA. The agency recommends that results of the test be confirmed with another test.

OraSure expects to start shipping the first tests to Abbott Laboratories Inc. for distribution by year’s end, OraSure Chief Executive Mike Gausling told Reuters.

“Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results,” Health and Human Services Secretary Tommy Thompson said.

“With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus.”

An estimated one-quarter of the approximately 900,000 HIV-positive people in the United States do not know they are infected with the virus, according to the Centers for Disease Control and Prevention. Finding out their HIV status enables those infected with the disease to seek treatment and take steps to prevent spreading the virus.

The test can also be used to test pregnant women for HIV, enabling doctors to take precautionary steps to block newborns from being infected by HIV-positive mothers.

It will also quickly identify health care and emergency workers who are accidentally exposed to HIV-infected blood while at work.

At first, the OraQuick test will only be available for use in hospitals and major clinics that have labs approved for the test. However, that may soon change, according to Thompson.

?If the FDA finds that the company’s data proves that the OraQuick test is both easy and safe to use, it can get a [waiver.] Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers. But the process can’t begin until OraSure applies for the waiver, so I ask them to please apply now!” Thompson urged in a press statement.

OraSure plans to apply for the waiver, Gausling told Reuters.

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