What to know
- This table contains information about multiplex assays that have been cleared or authorized by FDA for simultaneous detection of influenza viruses and SARS-CoV-2.
Table
Table: Multiplex Assays Cleared or Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2 by FDA1
| Complexity2 | Manufacturer | Product | 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 | Quest Diagnostics | Quest Diagnostics RC COVID-19 +Flu RT-PCR | Nucleic acid detection | Roche cobas SARS-CoV-2 & Influenza A/B | Influenza A and B | Not Differentiated | SARS-CoV-2 | When ordered by a healthcare provider: NS specimen is self-collected at home using the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu | Patient ships the self-collected specimen to Quest Diagnostics overnight via FedEx. Test results are provided electronically to the healthcare provider and the patient. |
| 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.
Keep Reading:
CDC’s Influenza SARS-CoV-2 Multiplex Assay
- FDA cleared or authorized by FDA Emergency Use Authorization (EUA). A list of FDA cleared or FDA authorized influenza diagnostic tests is available.
- Clinical Laboratory Improvement Amendments require categorization of tests as waived, moderate or high complexity.
- 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.
- 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.