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

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.

This Lab Advisory was originally published by the CDC Laboratory Outreach Communication System (LOCS) here. Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.