Around ASF Blog
Volume 1 / Entry 17
July 5, 2012
The Food and Drug Administration (FDA) has approved the first over-the-counter, rapid HIV test to be sold for in-home, consumer use. The OraQuick testing kit, developed by OraSure, is exactly like the kits we use for our free, rapid HIV testing at ASF. Using a simple mouth swab, the test detects the presence of HIV anitbodies and returns results in about 20 minutes.
The test will be sold online and also in retails stores such as CVS, Walgreens and Wal-Mart. While the test is expected to cost more than the roughly $20 ASF pays per kit, it is expected to be below the $60 threshold. The extra cost will pay for toll-free call center personnel who will have received training to provide counseling and medical referrals to test users. Again, along with the test, counseling and referrals are provided by ASF staff at no cost.
The FDA approval for an in-home, rapid HIV test is welcome in testing circles. It will definitely allow greater access to HIV tests. And the ability to test privately, in your own home, deciding who, if anyone will be present with you when you test, may also open some minds to the idea of regular testing. The complete privacy of an in-home test may empower more people to get tested.
Of the roughly 1.2 million people living with HIV in the U.S., the Centers for Disease Control and Prevention (CDC) estimate that about one fifth of them don’t know they are infected with HIV. People infected with HIV have been found to be more likely to avoid the risky behaviors that transmit the virus. If we can reach those who do not know they are infected, we can keep them from unknowingly transmitting the virus to others. Regular testing is the only way to identify and subsequently educate and treat these people.
When used by professionals, the OraQuick test has proven to be 99% accurate. In-home trials are trending at about 92% accuracy for identifying the virus. However, the test has proven to be accurate 99.9% of the time in correctly ruling out those individuals not carrying the virus. The reason for the disparity is currently unknown, but OraSure expected the sensitivity of the test to drop when used by consumers.
So, it’s not perfect. In fact, the CDC has stated that if you feel you have been exposed to the HIV virus and have tested negative using the in-home test, retesting is recommended after 3 months since it takes some time for HIV antibodies to develop into detectable levels.
But, it is another weapon in efforts to prevent the 50,000 new HIV infections each year in the U.S. The kits are expected to be available to consumers in October of this year. Do yourself and your loved ones a favor, “Take the Initiative. Take the Test.”
Thanks for reading!
Director of Communications and Public Relations