The U.S. Food and Drug Administration has approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 and type 2.
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 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 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. But 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, according to the FDA.
The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States have HIV, and about one in five are not aware of their infection. About 50,000 HIV infections begin 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,” Karen Midthun, MD, director of the FDAs Center for Biologics Evaluation and Research, said in a news release. “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.”
A version of this test for use by trained technicians in clinical settings was approved in 2004.
Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92% for test sensitivity, meaning one false-negative result would be expected out of every 12 test results in HIV-infected individuals.
Those studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98% for test specificity, meaning 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 available via phone and open 24 hours a day, seven days a week. When the product becomes available to the public, 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. Information about the consumer support center and contact information is included in the test kit.