Over-the-Counter HIV Test Approved By FDA
July 4, 2012

Over-the-Counter HIV Test Approved By FDA

Connie K. Ho for redOrbit.com — Your Universe Online

According to the U.S. Food and Drug Administration (FDA), there are approximately 40,000 newly-diagnosed HIV infections annually. Interestingly enough, a large number of the infections were passed by those who are unaware that they had been affected. With these staggering statistics, many researchers have worked to remedy the situation and one step was made in that direction when the FDA recently approved the OraQuick In-Home HIV test, the first over-the-counter HIV test kit that can be used at home.

The HIV virus is known to cause the immune deficiency syndrome (AIDS). With the OraQuick In-Home HIV Test, people can collect an oral fluid sample from the upper and lower gums of the mouth, place the swab sample into a developer vial, and have tests results after 20 to 40 minutes. The HIV test kit that can be self-administrated to determine if the antibodies of the human immunodeficiency virus type (HIV-1) and type 2 (HIV-2) are present. Those who receive positive results of the test do not necessarily demonstrate that they have been infected with HIV, but it does show that more testing needs to be done to confirm the exam results. As well, a negative test result does not signify that there is not a presence of HIV antibodies, especially if the exam was taken within three months of exposure. Overall, representatives from the FDA believe that the test can help diagnose previously unidentified HIV infections.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” remarked Dr. Karen Midthun, director of the FDA´s Center for Biologics Evaluation and Research, in a prepared statement. “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.”

Past clinical studies on self-testing demonstrate that OraQuick In-Home HIV test performs 92 percent accurately in determining if a person has HIV, which means that one out 12 tests could be a false negative. The test correctly gave a negative result for individuals unaffected with HIV in 99.88 percent of cases which means that there would be one false positive test out of 5,000 tests.

The test is manufactured by OraSure Technologies, which will have a consumer support center opened 24 hours a day. The center will be available to educate consumers about HIV/AIDS, correct ways of administering the exam, and recommendations on what to do following the test results.

According to Reuters, the test will be sold beginning in October with a price to be announced closer to the launch date. OraSure estimates that the retail price will be a little over $17.50, which is the price currently for professional use that includes costs for packaging, labeling, and other finances. It will be available to over 30,000 retailers and online.

"We set out with a clear purpose - to dramatically impact the number of people getting tested for HIV nationwide," Douglas Michels, OraSure's chief executive, remarked in a reporters´ conference call. "Today's FDA approval of OraQuick brings us much closer to accomplishing that goal."

Last May, an FDA advisory committee of outside experts unanimously voted for the test. The group recommended the test as it could prevent new HIV infections as well as recommend people to medical care and social services.

“If this enhances the number of people you can get into care, the advantages outweigh any objections,” Dr. Anthony S. Fauci, the longtime AIDS researcher of the National Institute of Allergy and Infectious Diseases, told the New York Times.