Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories

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Submitted by BBLX on Wed, 02/05/2020 - 23:40
Title
Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories
Memo #
20-10-CLIA
Posting Date
2020-02-06
Fiscal Year
2020
Summary
The Centers for Medicare & Medicaid Services (CMS) is providing guidance to surveyors in regards to the authorization for emergency use of the Centers for Disease Control (CDC)’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay and the deployment into CDC qualified, and, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests). • Assays that have been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) remain subject CLIA regulations. • The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and the corresponding protocols have been developed by the CDC for use by CDC qualified laboratories and the assay has been issued an EUA from the FDA. • Upon receipt of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel assay and corresponding Manufacturer’s Instructions (MI), CDC qualified laboratories will verify assay performance specifications in their laboratory per the manufacturer’s instructions. • CMS is also providing guidance for surveyors to notify their CMS Location if they discover a laboratory using an assay without an EUA that is testing for the same agent for which the emergency has been declared, or a modified EUA assay. The CMS Location will notify CMS Baltimore.