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

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.

This Lab Update was originally published by the CDC Laboratory Outreach Communication System (LOCS) here. Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.