What to know
Rapid molecular assays, reverse transcription-polymerase chain reaction (RT-PCR), and other molecular assays can identify the presence of influenza virus nucleic acids or RNA in respiratory specimens with high sensitivity (90-95%) and specificity. FDA-cleared rapid molecular assays produce results in approximately 15-30 minutes. Some rapid molecular assays are CLIA-waived for point-of-care use. Other molecular assays can detect and discriminate between infections with influenza A and B viruses; and can identify specific seasonal influenza A virus subtypes like influenza A(H1N1)pdm09 or A(H3N2). These assays can yield results in approximately 45 minutes to several hours depending upon the assay.
Table
FDA-cleared Nucleic Acid Detection Based Tests for Influenza Viruses1
| Complexity4 | Manufacturer | Product | Platform/ Instrument |
Influenza Virus Types Detected | Influenza A Virus Subtypes Detected | Other Respiratory Viruses Differentiated | Approved Specimens2 | Test Time3 |
|---|---|---|---|---|---|---|---|---|
| CLIA waived | Abbott | ID NOW™ Influenza A & B 2 | ID NOW™ Platform | Influenza A and B | None | None | NPS, NS direct, or NPS and NS in VTM | <15 min |
| CLIA waived | Cepheid | Xpert Xpress Flu | GeneXpert Xpress | Influenza A and B | None | None | NPS, NS in VTM | 30-60 min |
| CLIA waived | Cepheid | Xpert Xpress Flu/RSV | GeneXpert Xpress | Influenza A and B | None | Respiratory Syncytial Virus | NPS, NS in VTM | 30-60 min |
| CLIA waived | Roche Molecular Diagnostics | Cobas® Influenza A/B Assay | Cobas® Liat® Analyzer | Influenza A and B | None | None | NPS in VTM | <30 min |
| CLIA waived | Roche Molecular Diagnostics | Cobas® Influenza A/B & RSV Assay | Cobas® Liat® Analyzer | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | <30 min |
| CLIA waived | Sekisui Diagnostics | Silaris Influenza A & B | Silaris Dock | Influenza A and B | None | None | NS direct | <30 min |
| Moderate to High | BioMerieux | BIOFIRE® RESPIRATORY 2.1 (RP2.1) PANEL. |
FilmArray® FilmArray® Torch |
Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus (HKU1, NL63, 229E, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza Virus (1, 2, 3, 4) Respiratory Syncytial Virus and SARS-CoV-2 | NPS in saline | 1-2 hr |
| Moderate to High | BioMerieux | BIOFIRE® Respiratory 2.1plus (RP2.1plus) Panel | FilmArray 2.0®
FilmArray® Torch |
Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus (HKU1, NL63, 229E, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza Virus (1, 2, 3, 4) Respiratory Syncytial Virus, Sars-CoV-2 and MERS-CoV | NPS in saline | 30-60 min |
| Moderate | BioFire, Inc. BioMerieux |
BIOFIRE® Respiratory 2.1-EZ (RP2.1- EZ) Panel (EUA)* | FilmArray®2.0 FilmArray® Torch |
Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus (HKU1, NL63, 229E, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, MERS-CoV, Parainfluenza Virus (1, 2, 3, 4) Respiratory Syncytial Virus | NPS in VTM | 30-60 min |
| Moderate | Cepheid | Xpert Xpress Flu/RSV | GeneXpert | Influenza A and B | None | Respiratory Syncytial Virus | NPS, NW, NA in VTM | 1 hr |
| Moderate | Cepheid | Xpert Xpress Flu | GeneXpert | Influenza A and B | None | None | NPS in VTM | 30-60 min |
| Moderate | Cepheid | Xpert Xpress Flu/RSV | GeneXpert | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | 30-60 min |
| Moderate | DiaSorin Molecular | Simplexa Flu A/B & RSV Gen II | LIAISON MDX | Influenza A and B | None | Respiratory Syncytial Virus | NPS eluted in UTM | <2 hr |
| Moderate | Focus Diagnostics (DiaSorin) | Simplexa™ COVID-19 & Flu A/B Direct | Integrated Cycler | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | <2 hr |
| Moderate or High Complexity | Roche Diagnostics | cobas® eplex Respiratory Pathogen Panel 2 | ePlex | Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus (229E, HKU1, NL63, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza (1, 2, 3, 4), Respiratory Syncytial Virus (A, B) and SARS-CoV-2 | NPS in VTM | 2 hr |
| Moderate | Diasorin | VERIGENE® Respiratory Pathogens Flex Test | VERIGENE® System | Influenza A and B | H1/H1pdm09, H3 | Adenovirus, Human Metapneumovirus, Parainfluenza (1, 2, 3, 4), Rhinovirus, Respiratory Syncytial Virus (A, B) | NPS in VTM | 2.5 hr |
| Moderate | Quidel | Solana Influenza A+B Assay | Solana | Influenza A and B | None | None | NS, NPS in VTM | 30-60 min |
| Moderate | Qiagen GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel | QIAStat-Dx Analyzer | Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus HKU1, NL63, 229E, and OC43 Human Metapneumovirus A+B, Human Rhinovirus/Enterovirus, Parainfluenza Virus 1, 2, 3, 4, Respiratory Syncytial Virus | NPS in UTM only | 1 hr |
| High | Applied BioCode Inc. | BioCode Respiratory Pathogen Panel | BioCode® MDx-3000 System | Influenza A and B | H1, H3, H1pdm09 | Respiratory Syncytial Virus A/B, Parainfluenza viruses 1-4, Human Metapneumovirus A/B, Rhinovirus/Enterovirus, Adenovirus, Coronaviruses (229E, OC43, HKU1, NL63) | VTM or UTM | 5 hr |
| High | BioFire Diagnostics, Inc. (BioMérieux) | FilmArray Pneumonia Panel | FilmArray, FilmArray 2.0, or FilmArray Torch | Influenza A and B | None | Respiratory Syncytial Virus, Parainfluenza Virus, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Coronavirus | Induced/ expectorated sputum, TRA, BAL or mini-BAL | 1 hr |
| High | BioFire Diagnostics, Inc. (BioMérieux) | FilmArray Pneumonia Panel plus | FilmArray, FilmArray 2.0, or FilmArray Torch | Influenza A and B | None | Respiratory Syncytial Virus, Parainfluenza Virus, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Coronavirus | Induced/ expectorated sputum, TRA, BAL or mini-BAL | 1 hr |
| High | CDC Influenza Division | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit)5 | ABI 7500 Fast Dx | Influenza A and B | None | None | NPS, NS, TS, NA, NW, NPS/TS, BAL, BW, TRA, sputum, lung tissue, viral culture | 4 hr |
| High | CDC Influenza Division | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A Subtyping Kit)5 | ABI 7500 Fast Dx | Influenza A | None | None | NPS, NS, TS, NA, NW, NPS/TS, BAL, BW, TRA, sputum, lung tissue, viral culture | 4 hr |
| High | CDC Influenza Division | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza B Lineage Genotyping Kit)5 | ABI 7500 Fast Dx | Influenza B | Victoria-like lineage Yamagata-like lineage | None | NPS, NS, TS, NA, NW, NPS/TS, viral culture | 4 hr |
| High | CDC Influenza Division | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/H5 Subtyping Kit)5 | ABI 7500 Fast Dx | Influenza A | H5N1 (Asian lineage) | None | respiratory specimens and viral culture | 4 hr |
| Moderate | Focus Diagnostics (DiaSorin) | Simplexa® Flu A/B & RSV Direct Gen II | LIAISON® MDX | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | 90 minutes |
| High | Hologic | Panther Fusion® Flu A/B/RSV Assay | Panther | Influenza A and B | None | Respiratory Syncytial Virus | UTM or VTM | 2-4 hr |
| High | Diasorin | NxTAG® Respiratory Pathogen Panel. Also available: NxTAG® Respiratory Pathogen Panel v2 which contains SARS-CoV-2 |
MagPix | Influenza A and B | H1/H1pdm09, H3 | Adenovirus, Coronavirus (HKU1, NL63, 229E, OC43), Human Bocavirus, Human Metapneumovirus, Parainfluenza Virus (1, 2, 3, 4), Respiratory Syncytial Virus (A,B), Rhinovirus/Enterovirus | NPS in VTM | >3hrs |
| CLIA Waived | Abbott | ALINITY m RESP-4-PLEX ASSAY | ID NOW™ | Influenza A and B | None | Respiratory Syncytial Virus and SARS-CoV-2 | Nasopharyngeal swabs only | <115 minutes |
| High | Quidel Corporation | Lyra Influenza A + B Assay | ABI 7500 Fast Dx, QuantStudioTM Dx, Cepheid® SmartCycler® II | Influenza A and B | None | None | NS, NPS in VTM | 2-4 hr |
- Available FDA cleared tests as of August 2020. List may not include all available test kits approved by the FDA.
- These specimen types are specified in product package inserts cleared by the U.S. Food and Drug Administration (FDA).
- 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.
- Clinical Laboratory Improvement Amendments require categorization of tests as waived, moderate or high complexity.
- Available only to qualified DoD laboratories and U.S. public health laboratories.
- Available only to qualified DoD laboratories.
FDA = U.S. Food and Drug Administration
A = aspirate
B = bronchial
BAL = broncheoalveolar lavage
N = nasal
NP = nasopharyngeal
S = swab
T = throat
TR = tracheal
UTM = universal transport media
VTM = viral transport media
W = wash
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.