Although HIV affects more than 1 million Americans, with 40,000 new cases added each year, the disease's reputation is slowly evolving to that of a chronic disease rather than the death sentence it was in the 1980s. Sensing both a better psychological climate and an opportunity to promote the benefits of earlier detection, FDA is actively exploring the advisability of at-home testing for HIV—a subject it has wrestled with since 1986. Earlier this month, the agency's blood products advisory panel met with representatives from OraSure Technologies Inc. (Bethlehem, PA) to consider the company's OraQuick Advance Rapid HIV test as a potentially suitable candidate for at-home use.

OraSure's Michels: The need for an alternative.

OraSure's CEO and president, Douglas A. Michels, said, “For whatever reason, too many people aren't getting tested. They might be afraid to go to the clinic or enter into that discussion with their physician, but people have told us that if there was a test available that they could use in private, they would use it.”

OraQuick: Offering at-home detection?

The OraQuick test kit was approved by FDA in November 2002 and is available at doctors' offices, hospitals, and clinics worldwide. The test uses saliva to detect the presence of HIV antibodies within 20 minutes. OraSure says the test is 99% accurate, but notes that it will not detect the virus if the person only recently acquired HIV because it takes several weeks for antibodies to appear. The company also recommends that a positive result with OraQuick be confirmed through a second test administered by a doctor, hospital, or public health clinic.