Table 4. Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2 by FDA
|Complexity2||Manufacturer||Product||Platform/Instrument||Influenza Viruses Detected||Other Respiratory Viruses Differentiated||Approved Specimens3||Test Time4|
|High||CDC||Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay*||Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument||Influenza A, Influenza B||SARS-CoV-2||NPS, NPW, NPA, NS, NA, TS, sputum, TA, BAL||4 hours|
|High, Moderate||BioFire Diagnostics, LLC||BioFire Respiratory Panel 2.1 (RP2.1)||FILMARRAY® 2.0 and FILMARRAY® TORCH systems||Influenza A, A(H1), A(H1pdm09), A(H3), Influenza B||SARS-CoV-2,
Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus
|High, Moderate||QIAGEN||QIAstat-Dx Respiratory SARS-CoV-2 Panel||QIAstat Dx Analyzer System 1.0||Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B,||SARS-CoV-2, Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B||NPS in universal transport media||1 hour|
*The CDC-manufactured Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is designed for use at CDC-supported public health laboratories and will not replace any SARS-CoV-2 diagnostic tests currently used in commercial laboratories, hospitals, clinics, and other healthcare settings. More information for qualifying public health laboratories is available.
- Authorized by FDA Emergency Use Authorization (EUA) as of July 10, 2020. List may not include all assays available through FDA EUA.
- Clinical Laboratory Improvement Amendments require categorization of tests as waived, moderate or high complexity. Ref: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.htmlexternal icon
- NPS = nasopharyngeal swab; NPW = nasopharyngeal wash; NPA = nasopharyngeal aspirate; NS = nasal swab; NA = nasal aspirate; TS = throat swab; BAL = bronchoalveolar lavage fluid. These specimen types are specified in product package inserts authorized by FDA, available at: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecularexternal icon
- Test Time is inclusive of actual test time and is exclusive of transport, handling, laboratory run schedules, and generating results. Timing may vary depending on extraction process used. Contact laboratory for expected turn-around time.
Disclaimer: Use of trade names or commercial sources is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention or the Department of Health and Human Services.