Lab Notification: COVID-19 Diagnostic Testing Advisory

Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services The Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the CDC 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Diagnostic Panel which is to be used in qualified laboratories for testing patient respiratory specimens that meet CDC criteria for…

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Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)

Attention: Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services Please note that the “Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)” was updated on February 10, 2020. The revisions include: The term “certified”…

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QSO 20-10-CLIA: 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

On February 6, 2020, CMS published QSO 20-10-CLIA. Key Points: 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 Emergency Use Authorization (EUA) from the FDA. Upon receipt of the CDC 2019-nCoV Real-Time…

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CDC – Lab Update: Specimen Submission Information for the 2019 Novel Coronavirus (2019-nCoV)

At this time, diagnostic testing for 2019-nCoV can only be conducted at CDC. Healthcare providers should contact their local/state health department immediately to notify them about PUIs for 2019-nCoV. State health departments that have identified a PUI should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a 2019-nCoV PUI case investigation form…

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