04/13/2020: Lab Advisory: Updated Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

Updated Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

On March 30, 2020, the Food and Drug Administration (FDA) granted an Emergency Use Authorizations (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 three enzyme master mix options and provides clarification about acceptable specimens and the follow-up process for inconclusive test results. Find the IFU and the amendment letter on FDA’s Emergency Use Authorizationsexternal icon web site in the table titled “Test Kit Manufacturers and Commercial Laboratories.”

Online resources:

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: April 14, 2020