07/18/2020: Lab Advisory: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
Audience: Clinical Laboratory Professionals
Subject: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
Level: Laboratory Advisory
The US Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) amendment, authorizing an update to the Instructions for Use (IFU) of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This update includes the addition of the Promega Maxwell RSC 48 as an authorized extraction option for use with the test and an update of the in silico inclusivity analysis.
Review the updated IFU hereexternal icon.
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