07/08/2020: Lab Advisory: CDC Multiplex Assay Receives Authorization from FDA

Updated July 8, 2020

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Subject: Lab Advisory: CDC Multiplex Assay Receives Authorization from FDA

Level: Laboratory Advisory

On July 2, 2020, FDA granted an Emergency Use Authorization (EUA) for the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, a real-time RT-PCR test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens. For general information on the Influenza SARS-CoV-2 Multiplex Assay, refer to the CDC Frequently Asked Questions about COVID-19 for Laboratories.

On July 7, 2020, CDC updated the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests to include the LOINC test code and Vendor Specimen and Result Description SNOMED-CT codes. Please use these codes to report test results to public health.

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If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)