07/11/2020: Lab Update: FDA Updates Frequently Asked Questions about Testing for SARS-CoV-2

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Lab Update: FDA Updates Frequently Asked Questions about Testing for SARS-CoV-2

Level: Laboratory Update

The U.S. Food and Drug Administration (FDA) routinely updates its online Frequently Asked Questions (FAQs) about SARS-CoV-2 testing. On July 2, 2020, FDA added an FAQ that defines surveillance, screening, and diagnostic testing for COVID-19. Included in these definitions is a clarification that facilities must have a Clinical Laboratory Improvement Amendments (CLIA) certificate and meet all regulatory requirements if they report patient-specific results. Visit the updated FAQ pageexternal icon.

Additionally, FDA updated the Molecular Diagnostic templates to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples. View the updateexternal icon.

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: July 13, 2020