Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2 by FDA

What to know

  • Multiplex testing for influenza viruses and SARS-CoV-2 can facilitate early diagnosis and antiviral treatment of influenza and COVID-19.

Background

Influenza viruses and SARS-CoV-2, the virus that causes COVID-19, as well as other respiratory viruses usually co-circulate during the fall and winter months in most of the United States. Influenza viruses and SARS-CoV-2 can cause acute respiratory illnesses with similar signs and symptoms such as fever, chills, cough, malaise, sore throat, and headache.

Molecular testing, such as nucleic acid amplification tests (NAATs), is recommended for symptomatic patients suspected of having influenza and/or COVID-19 to help facilitate early initiation of treatment, if indicated. Although, limited data are available on evaluation of real-world use of tests for influenza and COVID-19 and the impact of multiplex testing on patient outcomes, early data suggests that use of point-of-care molecular multiplex influenza virus, SARS-CoV-2, and RSV testing resulted in fewer insurance claims, faster time to diagnosis, and faster time to treatment than laboratory-based molecular testing.

Information on available influenza assays, including multiplex assays for detection of influenza viruses and SARS-CoV-2 is available from FDA. . FDA also provides information on available at-home SARS CoV-2 tests, including at-home multiplex assays for detection of influenza viruses and SARS-CoV-2.