By Sean Henahan, Access Excellence

Chicago, IL ( Jan. 14, 1997) A bloodless HIV-antibody test using cells from the patient's gums provides a highly accurate alternative to blood testing, according to a study published in the Journal of the American Medical Association (JAMA).

More than 3,500 patients seen at general medical and public health clinics, blood banks, and clinics for HIV and other sexually transmitted diseases participated in the study. The sample consisted of 2,382 patients at low risk for HIV, 698 at high risk, 242 with AIDS, and 248 with diseases associated with increased frequency of false positive results in HIV testing. The study measured the accuracy of the the new test, "the OraSure System", by comparing results with true HIV-1 antibody status. The results showed that the OraSure system provided the correct result or would trigger appropriate follow-up testing in more than 99.9% of the cases.

"Though we have known for 10 years that antibodies against HIV-1 can be detected in the oral fluid of HIV-positive subjects, this is the first reliable method for gathering and testing oral samples," said John Fitchen, M.D., a lead investigator and coauthor of the JAMA article. "Our study demonstrates definitively that test results using oral samples obtained with OraSure are highly accurate, and that the system can be used in place of blood testing."

The Orasure technology uses a specimen called oral mucosal transudate (OMT), not saliva. OMT is obtained using a specially treated pad that is placed between the patient's gum and lower cheek for two minutes. The pad is then placed in a preservative and sent to a clinical laboratory where it is tested for the presence of HIV antibodies, the same way blood samples are tested. A single sample is sufficient for the initial screening test and for confirmatory testing, if indicated.

Until now, the most accurate way to evaluate HIV status was to obtain a blood sample. The new noninvasive method is considered safer for both patients and health care workers. The OraSure HIV-1 Western Blot Kit was cleared by the Food and Drug Administration (FDA) last June, and is available from health professionals.

"While the OraSure System is currently approved by the FDA for administration by a trained healthcare professional under the supervision of a physician, this technology may prove to be well suited for use as a home test in the future," said Dr. Fitchen. "Because it does not rely on a fingerstick or other means to obtain a blood sample, OraSure should increase access to HIV testing and therefore to counseling and early therapeutic interventions."

The research appeared in JAMA, 1/14/97.