CDC Updates SARS-CoV-2 Antigen Testing Guidance, CMS Revises Enforcement Discretion for SARS-CoV-2 Point-of-Care Tests, and FDA Authorizes Pooling for the CDC 2019-nCoV

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are links to the most recent messages about CDC SARS-CoV-2 antigen testing guidance updates, CMS enforcement discretion revisions for SARS-CoV-2 point-of-care tests, and FDA authorization of pooling for the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.

CDC Updates SARS-CoV-2 Antigen Testing Guidance

On December 5, 2020, CDC updated the Interim Guidance for Antigen Testing for SARS-CoV-2 Web page.

CMS Revises Enforcement Discretion for SARS-CoV-2 Point-of-Care Tests

On Monday, December 7, 2020, the Centers for Medicare & Medicaid Services (CMS) updated the frequently asked questions (FAQs) to include revised Clinical Laboratory Improvement Amendments (CLIA) enforcement discretion guidance during the COVID-19 public health emergency, for the use of SARS-CoV-2 molecular and antigen tests authorized by the U.S. Food and Drug Administration (FDA).

FDA Authorizes Pooling for the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel

On Tuesday, December 1, 2020, the U.S. Food and Drug Administration (FDA) authorized pooling for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.