Home HIV Test Kits Face Fierce Fight

The OraQuick HIV test, which detects the virus in either saliva or blood in just minutes with better than 99 percent accuracy, was the first rapid HIV test to receive U.S. government approval for use by medical professionals and is the only product of its kind available in health-care facilities throughout the United States. Mike Gausling, chief executive officer of test-maker OraSure Technologies Inc., said the company wants the test to gain over-the-counter approval. These efforts, however, are running into resistance from the laboratory industry and organizations that provide HIV/AIDS counseling.

Counselors and labs -- both powerful groups whose prominent roles in the AIDS fight could be unsettled by the effort -- have a history of fighting home HIV testing. Their opposition, according to some experts, is partly based on institutional biases. "You have to consider the potential conflict of interest when you interpret their concerns," said Dr. Bernard Branson, an AIDS specialist at CDC.

While OraQuick's supporters say easier access to the test would enable more people to find out their status and then take the appropriate precautions, labs argue that nonprofessionals are unqualified to perform the tests. "Either a false-positive or false-negative could have devastating results for the patient, his or her family and, potentially, society," argued a 2002 letter to Health and Human Services Secretary Tommy Thompson from the American Association for Clinical Chemistry, a 10,000-member laboratory lobbying group.

Counselors also give compelling arguments against home HIV testing grounded in two decades of experience. "I've been there. I've delivered the news," said Dr. Tim Friel, an infectious disease specialist at Lehigh Valley Hospital in Pennsylvania. "I just don't think you can provide that message adequately on a package insert." Friel said it is risky to assume that people taking a home HIV test will take the necessary prevention precautions. "I don't think you can make those leaps of faith," he said.

The final decision will be the government's. Last year, a CDC policy statement said that counseling "should not be a barrier to testing." CDC has hired an independent contractor to assess the public's interest in rapid home testing and to get a better understanding of how the public would use the test.

Back to other news for May 3, 2004