July 9 LOCS (CDC) Email
Subject: CDC Multiplex Assay Receives Authorization from FDA
Audience: Clinical Laboratory Professionals
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.