New York Times Examines Rapid HIV Testing, Debate Over OTC Use; Newsweek Profiles OraSure CEO, Oral HIV Test

The New York Times on Saturday examined rapid HIV testing -- which has become the center of the U.S. strategy to prevent the disease and some say has "revolutionized" testing -- and the debate surrounding FDA's consideration of a proposal to allow over-the-counter access to the test. Prior to the approval of the two currently available rapid tests in 2002 and 2004, most federal programs focused on encouraging HIV-negative people to make behavioral changes to prevent HIV infection. With the availability of rapid testing, CDC is directing its prevention efforts at encouraging people to undergo HIV testing to determine their status early, before they spread the virus to others and when treatment is more effective, according to Ronald Valdiserri, acting director of CDC's National Center for HIV, STD and TB Prevention (Leland, New York Times, 11/5). An FDA advisory committee on Thursday heard testimony on a proposal to allow consumers to use OraSure Technologies' OraQuick Advance Rapid HIV 1/2 Antibody Test at home (Kaiser Daily HIV/AIDS Report, 11/4). Proponents of at-home HIV testing say it will reduce stigma and other obstacles to testing, and research shows people are less likely to spread the virus if they learn they are HIV-positive, the Times reports. Opponents of home testing say that along with the results, patients need education and counseling. FDA approved an at-home HIV test in 1996, but users mail a blood sample to a laboratory and access the results through a telephone hotline that has access to counselors (New York Times, 11/5).

Newsweek Profiles OraSure CEO, OraQuick HIV Test
The Nov. 14 issue of Newsweek examined OraSure CEO Douglas Michels and the company's OraQuick test. FDA approved OraQuick for use in physicians' offices and laboratories in 2004 (Brant, Newsweek, 11/14). The test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 11/4). CDC has been purchasing OraQuick in bulk and distributing the test to clinics, and OraSure sells the test to developing countries for $5 each, or one-third of the price in the U.S. According to Newsweek, the percentage of people who obtain their test results has increased because of OraQuick. In New Jersey, for example, 34% of patients did not return for their test results with standard laboratory testing, which can take two weeks to return results. However, 100% of patients who were tested using OraQuick received their results (Newsweek, 11/14).

Back to other news for November 8, 2005