The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse-transcription polymerase chain reaction (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. The assay provides a sensitive, nucleic-acid-based diagnostic tool for evaluation of specimens from patients in the acute phase of infection.
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for this test on July 2, 2020.
The CDC Flu SC2 Multiplex Assay FDA-authorized Instructions for Use contains information about the test and its intended use, the test procedure, and the test performance characteristics. The FDA Letter of Authorization for the CDC Flu SC2 Multiplex Assay can be found on the EUA website. The letter defines the authorized use and the conditions of authorization that apply to CDC and other testing laboratories that use this test. Manufacturers and test developers interested in the right of reference to the CDC Flu SC2 Multiplex Assay performance data are encouraged to read these FAQs.
On November 20, 2020, FDA granted an amendment to the EUA for the CDC Flu SC2 Multiplex Assay to expand the list of extraction instruments that may be used to prepare samples for testing. Included in this amendment:
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