Table 4. Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2 by FDA

Table 4. Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2 by FDA Emergency Use Authorization 1
Complexity2 Manufacturer Product/information Virus Detection Method Platform/Instrument Influenza Viruses Detected Influenza A Virus Subtypes Differentiated Other Respiratory Viruses Differentiated Approved Specimens3 Test Time4
High, Moderate BioFire Diagnostics, LLC
(Commercially Available)
BioFire Respiratory Panel 2.1 (RP2.1) Nucleic Acid Detection FILMARRAY® 2.0 and FILMARRAY® TORCH systems Influenza A, Influenza B A(H1),
A(H1)pdm09,
A(H3)
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

NPS 1 hour
High, Moderate, Waived BioFire Diagnostics, LLC (Commercially Available) BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) Nucleic Acid Detection FILMARRAY® 2.0 EZ Configuration System Influenza A and B A(H1),
A(H1)pdm09,
A(H3)
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
NPS

Approximately 45 minutes

High, Moderate GenMark Diagnostics, Inc ePlex Respiratory Pathogen Panel 2 Nucleic Acid Detection ePlex System Influenza A and B A(H1),
A(H1)pdm09,
A(H3)
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 A, Respiratory Syncytial Virus B
NPS in viral transport media

<2 hours

High, Moderate QIAGEN
(Commercially Available)
QIAstat-Dx Respiratory SARS-CoV-2 Panel Nucleic Acid Detection QIAstat Dx Analyzer System 1.0 Influenza A, Influenza B A(H1),
A(H1)pdm09,
A(H3)
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
High, Moderate Roche Molecular Systems, Inc.
(Commercially Available)
cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Cobas 6800/8800 Systems Influenza A, Influenza B Not Differentiated SARS-CoV-2 Healthcare provider-collected NPS and NS, and self-collected NS (collected in a healthcare setting with instruction by a healthcare provider) 3-8 hours
High, Moderate, Waived Roche Molecular Systems, Inc.
(Commercially Available)
cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test Nucleic Acid Detection Cobas Liat Systems Influenza A, Influenza B Not Differentiated SARS-CoV-2 Healthcare provider-collected NPS and NS, and self-collected NS (collected in a healthcare setting with instruction by a healthcare provider) 20 minutes
High, Moderate Cepheid
(Commercially Available)
Xpert Xpress
SARS-CoV-2/
Flu/RSV
Nucleic Acid Detection GeneXpert Dx and GeneXpert Infinity systems Influenza A and B Not Differentiated SARS-CoV-2, RSV NPS, NS, NW/NA <40 minutes
Waived Cepheid
(Commercially Available)
Xpert Xpress
SARS-CoV-2/
Flu/RSV
Nucleic Acid Detection GeneXpert Xpress System (Tablet and Hub Configurations) Influenza A and B Not Differentiated SARS-CoV-2, RSV NPS <40 minutes
High, Moderate, Waived Quidel Sofia 2 Flu + SARS Antigen FIA Antigen Detection Sofia FIA Analyzer Influenza A, Influenza B Not Differentiated SARS-CoV-2 NPS, NS within first 5 days of onset of symptoms 15 minutes
High CDC
(Public Health Use Only, Not Commercially Available)
Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay* Nucleic Acid Detection Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument Influenza A, Influenza B Not Differentiated SARS-CoV-2 NPS, NPW, NPA, NS, NA, TS, sputum, TA, BAL 4 hours

*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.

  1. Authorized by FDA Emergency Use Authorization (EUA) as of October 19, 2020. List may not include all assays available through FDA EUA.
  2. 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
  3. NPS = nasopharyngeal swab; NPW = nasopharyngeal wash; NPA = nasopharyngeal aspirate; NS = nasal swab; NA = nasal aspirate; NW = nasal wash; 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
  4. 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.