Laboratory Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
Audience: Individuals Performing COVID-19
Level: Laboratory Alert
After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug
Administration (FDA) for Emergency Use
Authorization (EUA) of the CDC 2019-Novel
Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in
February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA- authorized alternatives.
Visit the FDA website for a list of authorized
COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.
In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019- nCoV RT-PCR assay select and begin their transition to another FDA-authorized
COVID-19 test. CDC encourages laboratories to consider adoption of a multiplexed method