The U.S. Centers for Disease Control and Prevention (CDC) after December 31, 2021, 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. The CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. As it turns out, the CDC now acknowledges challenges with the PCR test for testing both for COVID-19 and influenza. The CDC seeks to make a combined test that could be used as an assay for influenza and SARS-CoV-2.

After December 31, 2021, the CDC will withdraw the emergency use authorization of the PCR test for COVID-19 testing. The CDC finally admitted the test does not differentiate between the flu and COVID virus.

The FDA shares more on its 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, the 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 the adoption of a multiplexed method that can facilitate the detection and differentiation of SARS-CoV-2 and influenza viruses. Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season. Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.