The Blood Products Advisory Committee (BPAC) of the Food and Drug Administration voted 17- 0 May 15 in favor of a HIV home test.
If approved by the FDA at large, the test, which gives preliminary positive and negative results for strains of both HIV 1 and 2, could go on the market as early as this year.
“It fits into the national strategy for everyone to really know their HIV status. Not all people will go into a clinic or ask their primary care doctor to draw a test for them. This makes it more available,” said Dr. Patrick Chalk of the Baltimore City Health Department.
According to the CDC there are 50,000 new cases of HIV every year. Of the nearly 1.2 million Americans currently living with HIV, 25 percent are unaware of their status.
Studies from the CDC also show that while African Americans only account for 14 percent of the population, the group constituted 44 percent of new HIV cases in 2009, the most recent year for which data was available.
If approved for over-the counter use, the FDA expects that nearly 2.8 million Americans would take the opportunity to test themselves within the first year, according to ABC News.
The test is made by OraSure Technologies of Bethlehem, Pa., and can give a result back in 20 minutes with an accuracy rate of 93 percent. If a person receives a preliminary positive, further tests are sent off to a lab for confirmation.
“We definitely feel that this is going to reduce the stigma associated with HIV,” said Trina Scott, of Advocates for Youth, and organization focused on preventing and solving issues involving youth.
“We understand that young people are going to have more access and better options for HIV testing. They will learn their status and hopefully, once they take the test, they will reflect on their behaviors,” Scott said.
Health officials across the country have been weighing in on the possible new measure to combat the spread of HIV, the virus that causes AIDS. Though the ability to test in the privacy of one’s home has numerous pros, healthcare advocates say there is a downside to having that option available.
“If a young person finds out they are positive, how will they be able to process those emotions? There is no counselor there, and there may not be a support person, a parent, or a best friend there at the time,” Scott warned.
HIV can also take anywhere from three to six months to develop in the body before it will give a positive result in a test.
“With all HIV tests, the tests don’t look directly for the virus—they really look for the body’s response to the virus,” said Chalk. “They’re always lagging a couple of months behind on what you’re status really is. If you were infected a month ago, and you did a test—blood or oral—it would probably come up negative but you’re still really infected.” Though the test can give false negatives and false positives, all 17 members of the BPAC believed the benefits outweighed the risk of not having the product available for consumers at all.