CDC pulls EUA on early COVID-19 tests

The CDC asked clinical labs to consider the use of dual tests that can detect both the coronavirus and influenza virus in a July 21 notice. 

The agency recommended labs stock up on these types of testing kits as it looks to withdraw its emergency use authorization request to the FDA after Dec. 31 for one of the earliest real-time diagnostic tests for COVID-19. The CDC 2019-Novel Coronavirus Real-time [Polymerase Chain Reaction] Diagnostic Panel was introduced in February 2020 and detects only SARS-CoV-2, the virus that causes a COVID-19 infection. 

"CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives," the notice said, urging labs to adopt "a multiplexed method that can facilitate 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." 

To view the FDA's list of authorized COVID-19 diagnostic tests, click here.


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