06/29/2020: Lab Update: FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2

Audience: Clinical Laboratory Professionals

Level: Laboratory Update

FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have each recently posted information on their frequently asked questions pages about pooling procedures, particularly as they apply to COVID-19 surveillance testing.

View the FDA guidance here:  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#clinical

View the CMS guidance here: https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf

Online resources:

• Frequently Asked Questions about Coronavirus for Laboratories
• Clinical Laboratory COVID-19 Response Weekly Calls
• CDC’s Laboratory Outreach Communication System (LOCS)
• COVID-19 Information for Laboratories
• CDC COVID-19 website
• Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up

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/locs