WASHINGTON (From CNN) -- The first ever over-the-counter rapid HIV test was approved Tuesday by the Food and Drug Administration.
Users of the OraQuick In-Home HIV Test swab their upper and lower gums with the included test pad device and place it into a vial of solution. Much like a pregnancy test, one line shows up if the test is negative, two lines means a positive test. Test results take about 20 minutes.
A positive reading does not mean a definite human immunodeficiency virus, but that additional testing should be scheduled with a health professional. However, the FDA also cautions that 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."
The FDA approved another in-home test in 1996, however those samples needed to sent away to a lab for results. According to the Centers for Disease Control and Prevention about 1.2 million people in the United States are currently living with HIV, but about one in five don't know they're infected.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, 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."
In clinical trials the OraQuick performed at 99.98% for test specificity–the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals. A version of this test has been used by trained technicians in clinical settings since 2004.
OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test 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.
Douglas Michels, President and Chief Executive Officer of OraSure says the approval represents a major breakthrough in HIV testing. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting."
Orasure expects the kit to be available in stores and online in early October. The professional version of the kit sells in clinics for $17.50 but Michels believes the home kit will cost a little more. He says the price will be set by retailers. More than 30,000 stores will carry the test when it launches, he adds.
Post by: Saundra Young - CNN Medical Senior Producer