07/18/2020: Lab Advisory: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

CDC's Laboratory Outreach Communication System (LOCS)

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.

Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: July 19, 2020