FDA approve OTC HIV test in unanimous vote...
The FDA are one step closer to approving a new over-the-counter HIV test, which could be used to identify more HIV positive people and reduce the number of transmissions of the virus.
The OraQuick HIV test, developed by Pennsylvania-based OraSure, is basically a straightforward oral swab test, similar to the one taken by bone marrow donors, which returns the diagnosis with 20 minutes.
When performed by a professional trails have shown the test to be 99 percent accurate, however when it comes to take-home trails, the percentage drops to 93.
While 6 percent may sound like a small amount, it could be the difference between 3,800 correct diagnoses per year.
Nevertheless the benefits of making an OTC test available to the U.S market could potentially identify an extra 45,000 HIV positive people per annually, and prevent approx 4,000 transmissions.Image Credit: Jeffery Turner, 2008.
For this reason the OraQuick test received approval from 17 members of the FDA back in May. While the FDA noted that it’s not as reliable as professional-administered tests, it hopes that the test will lead to a new trend of take-home HIV tests.
And it’s clear that anything that inspires more people to test themselves, a potentially reduce the numbers of transmissions is a good thing. The numbers would agree too, in a recent survey of gay and bisexual men 89 percent said they would buy an OTC HIV test and test themselves more regularly.
The OraQuick HIV test is now waiting final approval later this year.
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- Molly Oswaks: Take-Home HIV Test Approved by FDA in Unanimous Vote Could Prevent Thousands of Transmissions, Annually. , 05/15/2012.