11/27/2020: Lab Advisory: FDA Issues EUA Amendment for CDC Influenza SARS-CoV-2 Multiplex Assay

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

On November 20, 2020, the U.S. Food and Drug Administration (FDA) granted an amendment to update the instructions for use (IFU) of the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay with general clarifications as well as the following:

  1. Additional Extraction Options Authorized
    a. Roche MagNA Pure Compact
    b. QIAGEN QIAcube HT
    c. ThermoFisher KingFisher Flex Purification System
    d. bioMérieux NucliSENS easyMAG
  2. Expanded Catalog Offerings for Reagent Kits
    a. Reagent kits available as the original full kit (Catalog # Flu-SC2-EUA) or
    b. Split into two separate kits: one that contains the primers and probes entitled Influenza SARS-CoV-2 Multiplex Assay Primer and Probe Kit (Catalog # Flu-SC2PP-EUA) and one that contains the positive controls entitled Influenza SARS-CoV-2 Multiplex Assay Positive Controls Kit (Catalog # Flu-SC2PC-EUA)
  3. Revised Alternative Filter Calibration
    a. IFU now advises use of the JOE filter instead of the VIC filter when using the alternative filter calibrations option for the ABI 7500 Fast Dx Real-time PCR instrument.

Additionally, on Tuesday, November 24, the Association of Public Health Laboratories (APHL) released the document Implementation of the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. Refer to this document for several clarifications and helpful tips identified during the implementation of the CDC Flu SC2 assay.

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For 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)