Attention: Clinical Laboratories

Please share this announcement with:

  • Medical Director, Laboratory Services
  • Administrative Director and Manager(s), Laboratory Services

Posted 08.16.2020 by: Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)

For laboratories using any Emergency Use Authorization (EUA) assay, it is a best practice (and required under some letters of authorization) to report any suspected instances of false positive or false negative results to both the U.S. Food and Drug Administration (FDA) and the manufacturer. Reports to FDA can be submitted online or via email. The reliability of diagnostic data is critical to the response. If you identify a possible issue, please report it.

For more information about false negative and false positive results when testing patients for COVID-19, click here to view the new frequently asked questions (FAQs).

Additionally, CDC recently published new FAQs about surveillance, screening, and diagnostic testing for COVID-19. Click here to view the new FAQs.

Online resources:

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