FDA Paves Way for Over the Counter HIV Test

The FDA advisory panel voted unanimously to make home HIV test available over the counter. That means anyone can purchase the inexpensive HIV test and take it in the privacy of their own home.
The story reported in the Washington post, reports the over the counter test is an oral mouth swab much like the Orasure tests available in many health clinics. According to the Washington Post, results could be available in as little as 20 minutes and has a 93% accuracy rate for detecting HIV in infected persons and 99% accurate in determining that someone is not HIV+. The tests may be available in drug stores soon. While this was only approved by the FDA advisory panel and the FDA must still approve it, historically, the FDA’s decisions are based on the recommendations of the panel.
The test is designed to be affordable as well. The current price for an oral test in a clinic is $17.95. It is estimated the price for the over the counter test will be just slightly higher because of more elaborate packaging. While it is true there are many free HIV testing sites, this test may be beneficial for those who are uncomfortable going to a clinic to be tested, want to guarantee their privacy or for people living in rural areas where testing sites are not easily accessible.
The committee did voice some concern about the ramifications of someone finding out they are HIV+ from a home test with no clinic support. However, the potential to encourage people to get tested and the general awareness was deemed more important than their concerns.
Currently, there are an estimated 1.2 million Americans who are infected with HIV according to CDC records. However it must be taken into consideration that statistics can only measure recorded cases of HIV. Since an estimated 44% of Americans have never been tested this number could be much higher and the CDC estimates 1 in 5 people who are HIV+ don’t know they are infected. The home test could help increase the number of people tested each year and the FDA estimated it could help diagnose 45,000 new HIV cases a year and prevent 4,000 new infections since theoretically once someone finds out they are HIV+ they would take steps to prevent infecting anyone else.
This new over the counter test has potential to do great things in the battle against HIV.
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