06/29/2020: Lab Update: FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2
Updated January 26, 2023
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)