08/16/2020: Lab Alert: Report False Negatives and False Positives from COVID-19 Testing + Review New Frequently Asked Questions

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Laboratory Alert: Report False Negatives and False Positives from COVID-19 Testing + Review New Frequently Asked Questions

Level: Laboratory Alert

For laboratories using any Emergency Use Authorization (EUA)external icon 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 onlineexternal icon 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:

If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: August 16, 2020