April 13 LOCS (CDC) Email

Subject: Lab Advisory: Updated Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory

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 Authorizations web site in the table titled “Test Kit Manufacturers and Commercial Laboratories.”

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