08/16/2020: Lab Alert: Report False Negatives and False Positives from COVID-19 Testing + Review New Frequently Asked Questions
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) 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:
- Information for Laboratories about COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- CDC’s Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up.
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)