The first over-the-counter, self-administered test for human immunodeficiency virus infection has been approved by the U.S. Food and Drug Administration. The OraQuick In-Home HIV test detects antibodies to HIV-1 and HIV-2 using oral fluid obtained by swabbing the upper and lower gums of the mouth. The sample swab is placed in a developer vial and yields results within 20 to 40 minutes, the FDA said in a statement.
In clinical studies of self-testing, the OraQuick In-Home HIV Test had 92% sensitivity (one false negative result would be expected out of every 12 test results in HIV-infected individuals). Test specificity was 99.98% (one false positive would be expected out of every 5,000 test results in uninfected individuals). The agency warns that a negative test result does not mean that an individual is definitely not infected with HIV, particularly when HIV exposure may have occurred within 3 months of testing and before antibody production could be detected. Also, positive test results should prompt confirmatory testing with a health care professional.
"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," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research said in a statement. OraSure Technologies expects to release the test for use starting in early October. They will provide a retail price closer to the date of release, according to Doug Michels, OraSure president and CEO. They also have a professional version of the test available for $17.50 for clinics and physician offices.
The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are infected with HIV and that nearly 1 in 5 don’t know they have it.