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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 here.
Online resources:
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC’s Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC COVID-19 website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19.
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)