Food and Drug Administration - June 20, 2008
Richard Klein & Kimberly Struble

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: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e618a1.htm?s_cid=mm5 7e618a1_e

A list of the FDA-approved rapid HIV antibody screening tests is available at: http://www.cdc.gov/hiv/topics/testing/rapid/rt-comparison.htm

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

080620
FD080602

SOURCE: Food and Drug Administration (FDA).

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