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FDA approves 1st over-the-counter home use HIV test kit

The U.S. Food and Drug Administration approved the first over-the-counter, self-administered HIV test kit.

The OraQuick In-Home HIV Test is designed to allow people to collect an oral fluid sample by swabbing the upper and lower gums, then place that sample into a developer vial, and obtain test results within 40 minutes. A positive result with this test does not necessarily mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.

Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection. About one in five are not aware they are infected. There are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, an FDA spokesperson. “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.”

Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 percent for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals.

Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98 percent for test specificity, the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.

OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a consumer support center that is available via phone and will be open 24 hours a day, seven days a week. The center will be operational and available to educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained once the manufacturer makes the product available for sale to the public.

The OraQuick In-Home HIV Test website is taking orders at: oraquickhivtestkit.com/. For more information, go to fda.gov.

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