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 Use in CDC Qualified Laboratories | NLM

Disaster Information Management Research Center | NLM

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 Use in CDC Qualified Laboratories

02/06/2020 12:00 AM EST

Source: Centers for Medicare and Medicaid Services (CMS). Published: 2/6/2020. This three-page memorandum provides guidance to surveyors in regard to the authorization for emergency use of the Centers for Disease Control and Prevention (CDC)’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel assay. 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. (PDF)