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SILVER SPRING — The U.S. Food and Drug Administration (FDA) on Tuesday approved the first over-the-counter, self-administered HIV test kit.
The FDA-approved OraQuick In-Home HIV Test detects the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome, better known as AIDS.
The test kit allows 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. However, the FDA noted that positive results should be followed by additional testing in a medical setting as it is not a definite result and requires medical confirmation.
Likewise, 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. Nonetheless, 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.
Studies showed 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, which means that one false negative result would be expected out of every 12 test results in HIV-infected individuals. It is also expected to have 99.98 percent performance for test specificity, the percentage of results that will be negative when HIV is not present.
"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. "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."
The Centers for Disease Control and Prevention (CDC) 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. Every year, there are about 50,000 new HIV infections, many of which are transmitted by people who are unaware of their HIV status.