November 5, 2020

FDA alerts providers on how to prevent false positive results with COVID-19 antigen tests

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on November 3 issued a letter alerting clinical laboratory staff and healthcare providers that false positive results can occur with antigen tests, including when users do not follow instructions for use of antigen tests for the rapid detection of COVID-19.

Among the FDA recommendations:

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  • following the test manufacturer’s instructions for use
  • allowing each specimen the proper time in the test device and for reading results
  • minimizing risks of cross-contamination
  • considering confirming positive results with a reverse transcription polymerase chain reaction test within 48 hours.


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