Frequently Asked Questions: Right of Reference to the CDC Influenza SARS-CoV-2 (Flu SC2) Performance Data for Manufacturers and Test Developers

Updated Oct. 18, 2020

No, CDC does not manufacture the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for use by hospital, community, or commercial laboratories.
CDC provides the Flu SC2 Multiplex Assay for use in designated state, tribal, local, and territorial government-supported public health laboratories. For more information, check with your health department.
CDC encourages commercial manufacturers to use the CDC-published assay design to pursue their own Emergency Use Authorization (EUA). Laboratories also can use the published assay design to create a laboratory-developed test (LDT).

Yes, however, the manufacturer must pursue its own EUA.
CDC is offering developers the right of reference to the Flu SC2 Multiplex Assay. The right of reference allows developers seeking EUA for a multi-analyte respiratory panel that includes SARS-CoV-2, to use the performance data already submitted to FDA as part of the CDC EUA request for the Flu SC2 Multiplex Assayexternal icon (FDA submission number EUA201781). This approach will help developers bring tests to the market more quickly.

Yes, however, the laboratory will need to manufacture the primers and probes or purchase them from a commercial vendor using the published design.
The laboratory will need to perform testing to meet all appropriate Clinical Laboratory Improvement Amendment (CLIA) regulations prior to reporting diagnostic results.
LDTs created using CDC’s design would not be authorized under the CDC Flu SC2 Multiplex Assay EUA.

CDC provides:
- Technical specifications for Flu SC2 Multiplex Assay primers and probes
- Right of reference to the performance data submitted to FDA as part of the CDC Flu SC2 Multiplex Assay EUA request
CDC does not provide:
- Quality control testing
- Positive controls – refer to the CDC Flu SC2 Multiplex Assay Instructions for Useexternal icon for additional information
- Validation panels
  - Exclusivity panels
  - Limit of Detection panels
- A CDC-manufactured kit to use for comparison or validation purposes

No license or agreement is necessary to use the CDC-published Flu SC2 Multiplex Assay primer and probe sequences. CDC has published these sequences to allow manufacturers and test developers to use this information for creation and/or distribution of their own test or components.
The CDC Flu SC2 Multiplex Assay uses proprietary components from other companies. Developers of commercial tests will need to obtain licenses from the manufacturers of these proprietary components or qualify alternative materials to use in their test.

Last Updated Oct. 18, 2020