The Centres for Disease Control and Prevention (CDC) has announced that it will, after December 31, 2021, withdraw the request to the US 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 was first introduced in February 2020 for detection of SARS-CoV-2 only.
The CDC said it was providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorised alternatives.
The agency said that in preparation for this change, it recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay to select and begin their transition to another FDA-authorised COVID-19 test.
The CDC said it was encouraging laboratories to consider adoption of 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,” CDC said. “Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.”