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Keyword: covidpxrtest

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  • 07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing ("to facilitate differentiation of SARS-CoV-2 and influenza virus")

    07/24/2021 12:18:30 PM PDT · by NoLibZone · 21 replies
    CDC ^ | July 21,2021 | CDC
    Audience: Individuals Performing COVID-19 Testing 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...