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Over-the-counter HIV testing in NEJM

This article was originally published in The Gray Sheet

Executive Summary

Ingrid Katz, MD, and Alexi Wright, MD, Brigham and Women's Hospital, Boston, support the prospect of OraSure gaining over-the-counter approval for its OraQuick Advance rapid oral HIV test. In a perspective piece in the Feb. 2 issue of the New England Journal of Medicine, the authors acknowledge concerns, including test affordability and the recent reports of increased numbers of false positive results at certain clinics, but they say a low number of false positives is less dangerous than people incorrectly assuming they do not have HIV. After attending an FDA advisory panel meeting in November that discussed whether HIV tests should be available for over-the-counter use, both authors feel confident that the product will be approved once these issues are ironed out, they said in an interview (1"The Gray Sheet" Jan. 2, 2006, p. 23)....
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