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HIV TESTING WITHOUT NEEDLES.

Several novel approaches to HIV testing have been marketed this year; the most recent is the OraSure system, which allows labs and professional offices to assay oral secretions for HIV-1 antibodies. This manufacturer-sponsored study compared the accuracy of the oral assay with that of standard blood tests.

In the OraSure protocol, a pad soaked in hypertonic saline is held in the back of the mouth for 2 minutes to absorb IgG-rich oral mucosal transudate, then packed in an antibacterial preservative and sent to a lab for routine ELISA detection of IgG antibodies to HIV and Western blot confirmation. Specimens from about 3500 subjects were processed at study laboratories, including patients at all stages of HIV infection, healthy controls, and HIV-negative patients with a variety of other viral and immunologic diseases.

Overall, the system correctly identified the presence of HIV antibodies in 99.9 percent of infected participants, and correctly indicated their absence in an equally high percentage of controls. There were no false positive results and only one false negative, in a person with late stage AIDS. Less than a dozen results were uninterpretable.

Comment: This test kit performs well; the manufacturer suggests it may be useful for needle-phobic patients and in situations where phlebotomy is not available. Undoubtedly, a home version is being developed as well.

— A Zuger

Published in Journal Watch General Medicine February 7, 1997

Citation(s):

Gallo D et al. Evaluation of a system using oral mucosal transudate for HIV-1 antibody screening and confirmatory testing. JAMA 1997 Jan 15 277 254-258.

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