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Report of false-positive oral fluid rapid HIV test results


Food and Drug Administration - June 20, 2008

The CDC is publishing important information in the Mortality and Morbidity Weekly Report (MMWR) about false-positive oral fluid rapid tests for HIV, reported in New York City between 2005 and 2008. The information highlights the importance of confirmatory testing, as required by product labeling, to confirm both oral fluid and whole-blood reactive rapid HIV tests.

Before testing, all patients should be informed that reactive rapid HIV test results are preliminary and require confirmation. In general, testing with blood or serum specimens is more accurate than testing with oral fluid and is preferred when feasible, especially in settings where blood specimens already are obtained routinely.

The complete article is available on the CDC web site at: 7e618a1_e A list of the FDA-approved rapid HIV antibody screening tests is available at:


Copyright © 2008 -FDA News, Publisher. All rights reserved to Food and Drug (FDA) Administration FDA.

Information in this article was accurate in June 20, 2008. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.