A do-it-yourself HIV test that provides results in as few as 20 minutes will face review from a key advisory panel of the Food and Drug Administration this week, which will decide whether to recommend the test for over-the-counter sales.
On Thursday, Nov. 3, the FDA’s Blood Products Advisory Committee will consider whether the OraQuick Advance test should be available in drug stores. The panel’s decision will serve only as a recommendation, but the FDA usually follows the advice of its advisory boards.
If ultimately given the go ahead by the FDA, the OraQuick test will be the first HIV test the FDA has approved to be administered without a healthcare provider on hand, moving the process of learning about an HIV infection from the controlled if cumbersome environs of clinics and doctors’ offices to unmonitored but far more accessible settings. OraQuick is already widely used in clinics and doctors’ offices.
The OraQuick test, manufactured by OraSure Technology in Bethlehem, Pa., is done by taking a swab of fluid from inside of the mouth and then testing it for the presence of HIV antibodies. It has proven accurate 99 percent of the time – on par with the traditional blood tests – though must be confirmed with a follow up blood test. OraSure told the Associated Press that it has not yet decided how much it would charge for the over-the-counter version of the test, but it now sells the kits to healthcare providers for $12 to $17.
The FDA first approved what is known in HIV parlance as “rapid testing” in 2003. OraQuick is one of four rapid tests that have won the agency’s stamp of approval for use in healthcare settings. Since its debut, both public health officials and AIDS activists have praised the technology for helping to get more people tested.
Typically, an HIV test requires a two-step, multi-week process. Individuals must first come and get blood drawn, then wait while that blood is sent to a lab and tested. They are usually asked to return in person to receive the results. Public health officials complain that far too many people never make it to the end of that process.
According to the Centers for Disease Control and Prevention, about a third of those who get tested each year disappear before learning the outcome, leaving a quarter of all test results undelivered. The CDC also estimates more than a quarter of the one million Americans living with HIV do not know they are infected, and thus are less likely to take steps to prevent passing the virus on to others.
The problem appears to be a particularly acute one for African Americans, who account for just under half of all people living with HIV in the U.S. In June, the CDC released the first in a series of behavioral studies that it is using to draw a more detailed portrait of the epidemic and its driving forces. In that study, which focused on homosexually and bisexually active men, 67 percent of positive Blacks were undiagnosed.
As a result, many of those working to stop HIV’s spread welcome new technology that makes HIV testing more accessible, and see OraQuick’s potential move from the staid confines of a clinic to the easy-access shelves of drug stores as a leap forward. “Overall, I would say they are a step forward,” said departing National Association of People With AIDS Executive Director Terje Anderson, talking to the Associated Press. “Anything that helps more people learn their status is a good thing.”
But rapid testing, even in a doctors’ office, is not without its critics. Some argue that the wait time between getting tested and learning the results can be useful, and that those who fail to return aren’t ready to deal with the answer the may get. While studies show that, in the long term, learning about an HIV infection reduces the likelihood that a person will engage in behavior that may spread it, there are no guarantees of a benefit in the short term. Some people simply go into denial; others react by actually increasing their risky behavior.
The emotional and social minefields that surround HIV testing have for years led the CDC and others to insist that tests be accompanied by counseling and the presence of healthcare workers who can help guide someone who has just learned about an infection to resources for help dealing with it. But in recent years the CDC has pushed to expand HIV testing, making it a far more “routine” part of doctors’ visits and other healthcare encounters. Critics say the agency risks going too far, stripping the process of crucial supports.