WASHINGTON — The U.S. Food and Drug Administration on Tuesday approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of HIV antibodies. HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
The OraQuick in-Home HIV test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes.
A positive result with this test does not 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.
Clinical studies for self-testing have shown that the OraQuick in-home 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.
The test has the potential to identify large numbers of previously undiagnosed HIV infections, according to the FDA, 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, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test, said it 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 provide users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained.
The professional version of the kit sells in clinics for $17.50 but Douglas Michels, President and Chief Executive Officer of OraSure, said the consumer product will like sell for “a little more,” with price ultimately being set by retailers.
The kit will be available online and in more than 30,000 stores when it launches in October, he said.