CDC Combined COVID-19/Influenza Test Gets FDA Emergency Use Authorization

The US Food and Drug Administration on Thursday granted Emergency Use Authorization to a molecular diagnostic test from the US Centers for Disease Control and Prevention that can detect and differentiate the viruses that cause COVID-19 and flu.

The Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time RT-PCR test intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleic acid in upper or lower respiratory specimens collected by a physician from individuals suspected of having a respiratory viral infection, according to its instructions for use. The test can be performed only in high-complexity CLIA laboratories.

The test specifically contains three primer/probe sets (InfA, InfB, and SC2) targeting the RNA of the influenza A and B viruses and SARS-CoV-2.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/cdc-combined-covid-19influenza-test-gets-fda-emergency-use