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