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:
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