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Overview
Newsweek  , The New York Times , The Philadelphia Inquirer , MedPage Today and other news outlets are reporting on recent efforts by OraSure Technologies Inc. (Bethlehem, PA) to obtain over-the-counter (OTC) status for the OraQuick ADVANCE Rapid HIV Antibody Test, a rapid test that screens oral fluids for antibodies against the human immunodeficiency virus (HIV).
OraQuick ADVANCE tests oral mucosal transudate for antibodies against HIV-1 or HIV-2. This is a preliminary test, and a positive result requires further tests to verify the presence of HIV antibodies.
OraQuick ADVANCE received FDA approval in March 2004 for use in clinical laboratories. Late in 2004, it was granted a Clinical Laboratory Improvement Amendments (CLIA) waiver, indicating that the test was sufficiently simple and accurate to be used in a wide variety of settings, including dental offices. In November 2005, OraSure presented the benefits of OTC at-home testing with the OraQuick ADVANCE to an advisory committee of the U.S. Food and Drug Administration (FDA). The FDA is currently gathering input from companies, counselors and public health officials on the safety and feasibility of rapid HIV testing in non-clinical settings.
Currently, all rapid HIV tests need to be accompanied by pre- and post-test counseling. For instance, pre-test counseling includes a determination of the time interval of possible exposure, since taking the test too soon after an exposure may result in a false-negative result. Post-test counseling for those that are positive covers the need for additional confirmative tests and partner notification. Such counseling would not be available to an individual who purchased OraQuick ADVANCE for use over-the-counter.
Dentists can provide a valuable service by making rapid HIV testing using oral fluids more widely available to the reportedly 250,000 people in the U.S. who do not know they are HIV infected. Only one such test—the OraQuick ADVANCE Rapid HIV Antibody Test—is approved by the FDA for analysis of oral fluids. Dentists who chose to administer the test must make sure they observe all federal, state and local regulations, including any restrictions relating to scope of practice. As noted in a recent JADA editorial , it is important for dentists to assist patients in obtaining pre- and post-test counseling as appropriate, and to refer patients to a physician for additional testing to confirm the HIV status.
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A–Z Topics: Human Immunodeficiency Virus (HIV)
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Science in the News is a service by the American Dental Association (ADA) to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.
Document Posted November 2005
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