Table 3. Nucleic Acid Detection Based Tests

Table 3.  FDA-cleared Nucleic Acid Detection Based Tests for Influenza Viruses1
Complexity4 Manufacturer Product Platform/
Instrument
Influenza Virus Types Detected Influenza Virus Subtypes Detected Other Respiratory Viruses Differentiated Approved Specimens2 Test Time3
CLIA waived Abbot 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 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
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
  1. Available FDA cleared tests as of December 2018. List may not include all available test kits approved by the FDA.
  2. These specimen types are specified in product package inserts cleared by the U.S. Food and Drug Administration (FDA)
  3. 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.
  4. 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
  5. Available only to qualified DoD laboratories and U.S. public health laboratories
  6. 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
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.