FDA Approves OTC HIV Test OraQuick

OraQuick, A Take Home HIV Test, Approved By FDA

The Food and Drug Administration has approved OraQuick, the first over-the-counter HIV test. The test is targeted toward people who would not otherwise get tested for the virus.

The OraQuick test uses saliva to detect the presence of HIV. The user swabs the upper and lower gums and inserts the device into developer solution. Within 20 to 40 minutes, the results will appear. One horizontal line means the result is negative and two horizontal lines means that HIV antibodies were detected and the user may be HIV positive.

While HIV testing in a laboratory setting is reliable and less likely to result in false positives, home test kits don’t carry the same certainty. The FDA said,

“Self-test results obtained with the OraQuick In-Home HIV test are less reliable, both because the screening test result is unconfirmed and because the sensitivity of the test was found to be reduced compared to that obtained when it is used by trained health care workers.”

In a trial conducted by OraSure, the developers of OraQuick, the test only correctly detected HIV 92 percent of the time, meaning one in 12 tests would present a false negative. However, the test was 99 percent accurate in ruling out HIV in users who did not carry the virus, meaning only one in 5,000 tests would present a false positive.

OraSure plans to start selling the consumer test at more than 30,000 retailers in October. The company hasn’t announced a price yet, but did say it would cost less than $60. The test for health professionals costs $17.50.

OraQuick received a unanimous vote by an FDA advisory panel in May, as the members believed that the benefits of a less accurate home test outweighed any incorrect results.

The Centers for Disease Control and Prevention (CDC) estimate that a fifth of the 1.2 million HIV carriers in the United States, roughly 240,000 people, are unaware of their status. Testing helps slow new infections, which has remained steady at about 50,000 new cases for the last two decades.

OraSure’s president and CEO said in a statement,

“We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide. Today’s FDA approval of OraQuick brings us much closer to accomplishing that goal.”