Multiplex Real-Time Reverse Transcription PCR for Influenza A Virus, Influenza B Virus, and Severe Acute Respiratory Syndrome Coronavirus 2

Shu, Bo; Kirby, Marie K.; Davis, William G.; Warnes, Christine; Liddell, Jimma; Liu, Ji; Wu, Kai-Hui; Hassell, Norman; Benitez, Alvaro J.; Wilson, Malania M.; Keller, Matthew W.; Rambo-Martin, Benjamin L.; Camara, Yamundow; Winter, Jörn; Kondor, Rebecca J.; Zhou, Bin; Spies, Stacey; Rose, Laura E.; Winchell, Jonas M.; Limbago, Brandi M.; Wentworth, David E.; Barnes, John R.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019, and the outbreak rapidly evolved into the current coronavirus disease pandemic. SARS-CoV-2 is a respiratory virus that causes symptoms similar to those caused by influenza A and B viruses. On July 2, 2020, the US Food and Drug Administration granted emergency use authorization for in vitro diagnostic use of the Influenza SARS-CoV-2 Multiplex Assay. This assay detects influenza A virus at 10(2.0), influenza B virus at 10(2.2), and SARS-CoV-2 at 10(0.3) 50% tissue culture or egg infectious dose, or as few as 5 RNA copies/reaction. The simultaneous detection and differentiation of these 3 major pathogens increases overall testing capacity, conserves resources, identifies co-infections, and enables efficient surveillance of influenza viruses and SARS-CoV-2.