A federal agency this week paved the way for a new method of HIV testing.
The U.S. Food and Drug Administration on Tuesday gave its approval for the first over-the-counter, self-administered home test kit for HIV.
The OraQuick In-Home HIV Test is manufactured by OraSure Technologies Inc., located in Bethlehem.
The product enables individuals to take an oral-fluid swab from inside the mouth and obtain a reading within 20-40 minutes.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of 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.”
In clinical studies, the home-test kit had about a 92-percent accuracy rate for those who are positive, translating to about one false negative for every 12 tests taken by HIV-positive people. Its performance rate stands at 99.98 percent, however, for those who are HIV-negative, meaning a false positive would be reported about one in every 5,000 tests taken by HIV-negative people.
The kit has been largely hailed by HIV/AIDS advocates as an innovative way to standardize HIV testing and reach populations uncomfortable with being tested in standard health-care settings.
However, advocates have cautioned that the product provides a preliminary means of identifying those who are HIV-positive and that, if a positive result is yielded, the individual should immediately contact a health-care provider for confirmatory and follow-up testing.
Once the product hits the shelves, OraSure will have a 24/7 hotline that consumers can contact with questions about the test and their results.
The kit is expected to cost about $60.
An FDA panel estimated the product could diagnose about 45,000 new HIV cases each year and could prevent about 4,000 new transmissions annually.