Table 3. Nucleic Acid Detection Based Tests
| 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 | BioFire, Inc. BioMerieux |
FilmArray® Respiratory Panel EZ | FilmArray 2.0 EZ | Influenza A and B | H1, H1pdm09, H3 | Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza Virus, Respiratory Syncytial Virus | NPS in VTM | 1-2 hr |
| 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 | Mesa Biotech. Inc | Accula Flu A/Flu B | Accula Dock | Influenza A and B | None | None | NS direct | <30 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 | BioFire, Inc. BioMerieux |
FilmArray Respiratory 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 | NPS in VTM | 1-2 hr |
| Moderate | BioFire, Inc. BioMerieux |
FilmArray Respiratory Panel 2 | 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 | NPS in VTM | 30-60 min |
| Moderate | BioFire, Inc. BioMerieux |
FilmArray Respiratory Panel 2 plus | 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 Flu | GeneXpert | Influenza A and B | H1pdm09 | None | NPS in VTM, NA, NW | 1 hr |
| 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™ Flu A/B & RSV Direct | Integrated Cycler | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | <2 hr |
| Moderate | Focus Diagnostics (DiaSorin) | Simplexa™ H1N1 2009 | Integrated Cycler | Influenza A | None | Respiratory Syncytial Virus | NPS, NA, NPA | 2-4 hr |
| Moderate | GenMark Diagnostics | ePlex Respiratory Pathogen Panel | 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) | NPS in VTM | 2 hr |
| Moderate | Biocartis | Idylla™ Respiratory IFV-RSV Panel | Idylla | Influenza A and B | H1, H1pdm09, H3, H275Y mutation (H1N1pdm09) | Respiratory Syncytial Virus | NPS in VTM | 30-60 min |
| Moderate | Luminex | Aries® Flu A/B & RSV | Aries | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | 1-2 hr |
| Moderate | Luminex | Verigene Respiratory Virus Nucleic Acid Test Plus | Verigene SP | Influenza A and B | None | None | NPS in VTM | 3.5 hr |
| Moderate | Luminex | Verigene Respiratory Virus Nucleic Acid Test Plus | Verigene SP | Influenza A and B | H1, H1pdm09, H3 | Respiratory Syncytial Virus (A, B) | NPS in VTM | 3.5 hr |
| Moderate | Luminex | Verigene RP Flex | VERIGENE Reader VERIGENE Processor SP |
Influenza A and B | H1/H1pdm09, H3 | Adenovirus, Human Metapneumovirus, Parainfluenza (1, 2, 3, 4), Rhinovirus, Respiratory Syncytial Virus (A, B) | NPS in VTM | 3.5 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 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 | NS, NPS in VTM | 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) | NPS eluted in 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 |
| High | Focus Diagnostics (DiaSorin) | Simplexa™ Flu A/B & RSV Kit | Integrated Cycler | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | <4 hr |
| High | Focus Diagnostics (DiaSorin) | Simplexa™ Influenza A H1N1 (2009) | Integrated Cycler | Influenza A | H1pdm09 | None | NPS, NS in VTM, NPA, NPW | <4 hr |
| High | GenMark Diagnostics | eSensor® Respiratory Viral Panel (RVP) | eSensor XT-8 system | Influenza A and B | H1, H1pdm09, H3 | Respiratory Syncytial Virus subtype (A,B), Parainfluenza Virus (1, 2, 3), Human Metapneumovirus, Adenovirus (B/E, C), Human Rhinovirus | NPS in VTM | 8 hr |
| High | Hologic | Panther Fusion® Flu A/B/RSV Assay | Panther | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | 2-4 hr |
| High | Hologic | Prodesse PROFLU +V | Cepheid SmartCycler II | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | <4 hr |
| High | Hologic | Prodesse ProFAST + | Cepheid SmartCycler II | Influenza A | H1, H1pdm09, H3 | None | NPS in VTM | <4 hr |
| High | Luminex | NxTAG Respiratory Viral Panel (RVP) | 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 | 4-8 hr |
| High | Luminex | x-TAG® Respiratory Viral Panel Fast (RVP FAST) | MagPix | Influenza A and B | H1, H1pdm09, H3 | Parainfluenza Virus (1, 2, 3, 4), Respiratory Syncytial Virus, Huamn Metapneumovirus, Human Bocavirus, Rhinovirus, Corona Virus (NL63, 229E, OC43, HKU1), Adenovirus | NPS in VTM | 6 hr |
| High | IMDx | IMDx Flu A/B and RSV for Abbott m2000 | Abbott m2000 | Influenza A and B | None | Respiratory Syncytial Virus | NPS in VTM | 4 hr |
| High | Quidel Corporation | Lyra Influenza A + B Assay | ABI 7500 Fast Dx, QuantStudioTM Dx, Cepheid® SmartCycler® II, Life Technologies QuantStudio Dx | Influenza A and B | None | None | NS, NPS in VTM | 2-4 hr |
| High | InDevR | FluChip-8G Influenza A+B Assay | BioRad T100 endpoint thermal cycler
FluChip-8G Imaging System with FluChip-8G Software v1.0.9.0 or newer |
Influenza A and B | Seasonal Flu A/H3N2, A/H1N1pdm09, and Non-seasonal Influenza A subtypes (i.e., not A/H3N2 or A/H1N1pdm09).
B/Victoria and B/Yamagata. |
None | NS, NPS in VTM | 6-8 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. Ref: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html
- 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.
Page last reviewed: August 27, 2020
