07/08/2020: Lab Advisory: CDC Multiplex Assay Receives Authorization from FDA
Updated July 8, 2020
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.
Online resources:
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC’s Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- Frequently Asked Questions about COVID-19 for Laboratories
- CDC COVID-19 website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up
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)