The FDA approved the first rapid oral HIV test, OraQuick Advance, in the fall of 2004—and AIDS advocates salivated. Finally: mobile, blood-free testing, simply by swabbing gums. But is it reliable? In late 2005, a rash of false OraQuick positives swallowed hope of immediate over-the-counter sales. At least ten HIV test sites subsequently dropped OraQuick—including the New York City Department of Health. But the majority of testing sites continue to swab.
Orasure Technologies, maker of OraQuick, has yet to pinpoint the problem—but maintains that the test is reliable. Preliminary Centers for Disease Control data show that clinical error, not the test itself, may be to blame, though they note that those testing positive should follow up with a blood test. As POZ went to press, the FDA was reconsidering over-the-counter sales. And Orasure’s stock, which slumped after the scandal, recovered when President Bush plugged rapid tests in his January 31 State of the Union Address. On-site OraQuick dispenser Jude de Los Reyes, of New York’s Gay Men’s Health Crisis, says, “Since OraQuick was introduced, we’ve tested more young people and people of color. We can even get tests to places like Gay Pride.” A truly positive result.