PARA Weekly eJournal: October 13, 2021
FDA TO WITHDRAW EUA ON COVID PCR TEST DECEMBER 31, 2021
On July 21, 2021, the CDC announced it will withdraw its Emergency Use Authorization (EUA) request for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel after December 31, 2021. The advanced notice allows laboratories to adopt and prepare to use an alternative FDA approved test. The 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel detects only COVID-19.The CDC suggests laboratories begin using a multiplex assay that can detect both COVID-19 and influenza, which will be save time and laboratory resources as we enter flu season. https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_ RT-PCR_SARS-CoV-2_Testing_1.html
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