FDA panel backs HIV over-the-counter test kit

A panel at the FDA has recommended the approval of an over-the-counter HIV test.

HIV prevention may be improved in the United States due to a new HIV testing kit that a panel at the Food and Drug Administration has recommended for distribution.

A panel at the FDA has recommended the approval of the over-the-counter HIV test, called the OraQuick In-Home HIV Test, and believe it is a safe and effective method that the general public should be able to purchase.

Even though there is a possibility of false results, the FDA's advisory panel believes that the kit's potential to help control the spread of the disease -- which often goes untested and carried by those who are not aware -- it is worth the effort to commercialize and distribute.

The FDA will decide this year if it is to be approved for commercial manufacture, the BBC reports. As 50,000 new cases are reported each year and a number must go untested and potentially causes additional infection, any way to provide detection of the disease -- especially in the privacy of a home -- may prove of benefit.

To take the test, an individual must swab the outer gum area of their mouth so the oral fluid can be checked for the presence of the HIV virus.

The OraQuick In-Home HIV Test is reported to take 20 minutes and is 93 percent accurate for positive results. According to the manufacturer, it is 99.8 percent effective for negative results. If results prove positive, then it is recommended this becomes confirmed with a blood test for higher accuracy.

The panel that has recommended approval of the kit, the Blood Products Advisory Committee, voted unanimously for the test. However, they also suggested that the manufacturer should include "highly visible" warnings on the packaging concerning false results, and that it should also contain a toll-free number for counselling if the test proves positive.

Carl Schmid, deputy director of the AIDS Institute, said:

"We are always looking for game changers, and we believe this is one of them.
Not only will it help reduce the number of infections but it will bring more people into care and treatment."

The maker, OraSure, says the home testing kit could be retailed at less than $60 if the FDA approve the panel's recommendation.

(via BBC)

Image credit: AZAdam


This post was originally published on Smartplanet.com