ARGENE® Respiratory range

A range of real-time PCR kits for accurate simultaneous detection of infectious agents involved in respiratory diseases

  • “à la carte” diagnosis thanks to modular duplex PCR solution
  • Ready-to-use kits including positive and negative controls
  • CE-IVD on all major extraction platforms and real-time PCR systems
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ARGENE® Respiratory menu

What could be easier? The ARGENE® Respiratory range of real-time PCR kits is your solution for detection of more than 35 respiratory pathogens involved in respiratory illness, thanks to its full menu:



 

ARGENE® Respiratory advantages

Acute Respiratory Infections (ARI) account for an estimated 75% of all acute morbidities in industrialized countries and continue to be the leading cause of acute illness worldwide. The most serious and potentially life-threatening pneumopathies occur mainly in young children, the elderly, and immunocompromised or weakened individuals (such as those with chronic disease, cancer, or in intensive care units). The vast majority of respiratory illnesses are caused by bacteria and viruses. Since symptomatologies are similar, appropriate diagnostic testing is essential to identifying infectious agents.

Optimized detection of infectious agents is necessary to ensure optimal patient management and to prevent the spread of infection.

  • Modular multiplex solution
    • Adopt a targeted diagnostic strategy with an “à la carte” menu
    • Choose which pathogens to test depending on the season
    • Allow the diagnosis of co-infections
  • Sensitive and reproducible
    • Reliable measurement of infectious agents involved in respiratory diseases
    • All controls included (positive and negative control, cell control)
  • Standardized
    • Uniform protocol for DNA & RNA targets
    • Parallel processing with the pathogens detected with the ARGENE® Respiratory range.
    • Harmonized test profiles for multiple assays in one run
  • Flexible
    • Validated for use with various respiratory samples types
    • Compatible with automated sample preparation systems such as NUCLISENS® easyMAG® and EMAG®, as well as user-friendly assay setup techniques such as ESTREAM® liquid handling system
    • Qualified with the major real-time PCR platforms

 

A complete kit with all you need

ARGENE® Respiratory kits are ready-to-use molecular kits for the detection of pathogens by real-time PCR after viral DNA & RNA extraction. This 5’ nuclease-based Taqman technology amplifies and simultaneously detects a specific region of the pathogen genome.

  • Cell control to validate the sample quality for some kits
  • Negative and Pathogen-specific Positive controls
  • Includes all necessary reagents optimized to detect pathogens for in vitro diagnostic use

Straightforward procedure

Using ARGENE® Respiratory range of assays is straightforward and simple. Just add the extracted DNA or RNA sample to the ready-to-use PCR master mix chosen and start the reaction on the appropriate Real-Time PCR thermocycler, following optimized cycling program described in the “Instructions For Use”.

 

BIOMERIEUX, the blue logo, ARGENE®, R-GENE®, EMAG® and NUCLISENS® easyMAG® are used, pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies. Any other name or trademark is the property of its respective owner.

Influenza A/B R-GENE®

Influenza A/B R-GENE® (71-040)
Principle of the test Duplex amplification and detection of Influenza A and Influenza B
Ordering information Reference 71-040 : Influenza A/B R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target Influenza A: M gene

Influenza B: M gene
Specimen* Respiratory samples
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform* EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

RSV/hMPV R-GENE®

RSV/hMPV R-GENE® (71-041)
Principle of the test Duplex amplification and detection of RSV (A&B) and hMPV (A&B)
Ordering information Reference 71-041: RSV/hMPV R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target RSV: N gene

hMPV: M gene
Specimen* Respiratory samples
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

Rhino&EV/Cc R-GENE®

Rhino&EV/Cc R-GENE® (71-042)
Principle of the test Duplex amplification and detection of Rhinovirus (A,B,C) & Enterovirus (A,B,C,D) and cellular control
Ordering information Reference 71-042: Rhino&EV/Cc R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target Rhinovirus & Enterovirus: 5’ non coding region Cell control: HPRT1 gene
Specimen* Respiratory samples (nasopharyngeal aspiration, nasal swab, nasal lavage, bronchoalveolar fluid)
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

AdV/HBoV R-GENE®

AdV/hBoV R-GENE® (71-043)
Principle of the test Duplex amplification and detection of Adenovirus (A,B,C,D,E,F,G) and Bocavirus (hBoV 1,2,3,4)
Ordering information Reference 71-043 : AdV/hBoV R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target Adenovirus: HEXON gene

Bocavirus: NS1 or VP1 gene
Specimen* Respiratory samples (nasopharyngeal aspiration, nasal swab, nasal lavage, bronchoalveolar fluid)
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

Chla/Myco pneumo R-GENE®

Chla/Myco pneumo R-GENE® (71-044)
Principle of the test Duplex amplification and detection of Chlamydia pneumoniae and Mycoplasma pneumoniae
Ordering information Reference 71-044 : Chla/Myco pneumo R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target Chlamydia pneumoniae: OMP2 gene

Mycoplasma pneumoniae: P1 gene
Specimen* Respiratory samples (nasopharyngeal aspiration, nasal swab, nasal lavage, bronchoalveolar fluid)
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

HCoV/HPIV R-GENE®

HCoV/HPIV R-GENE® (71-045)
Principle of the test Duplex detection of both human Coronaviruses (NL63, OC43, HKU1, 229E) and Parainfluenza viruses (HPIV1, HPIV 2, HPIV 3, HPIV4).
Ordering information Reference 71-045 : HCoV/HPIV R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target HCoV: N gene HPIV: N gene
Specimen* Respiratory samples
Controls included Positive control, negative control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

 

Legio pneumo /Cc R-GENE®

Legio pneumo R-GENE® (71-046)
Principle of the test Duplex amplification and detection of Legionella pneumophila (15 serogroups, including serogroup 1) and a cellular control
Ordering information Reference 71-046 : Legio pneumo/Cc R-GENE®
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target Legionella pneumophila : MIP gene

Cell control: HPRT1 gene
Specimen Bronchoalveolar lavage, tracheo-bronchial aspirates and sputum
Controls included Positive control, negative control, cell control
Results within 90 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Automated Extraction platform EMAG® NUCLISENS® easyMAG®

QIAsymphony SP
Validated Amplification platform*
ABI7500 Fast, ABI 7500 Fast Dx LightCycler 480 System II Rotor-Gene Q CFX96
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

 

 

BORDETELLA R-GENE® (69-011B)

BORDETELLA R-GENE® (69-011B)
Principle of the test Genomic detection of Bordetella pertussis
Ordering information Reference 69-011B: BORDETELLA R-GENE® kit
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target IS481 region
Specimen* Nasopharyngeal aspirations and expectorations
Controls included Extraction + Inhibition control, Negative control, Positive Control
Results within 75 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Extraction platform* EMAG®

NUCLISENS easyMAG®
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx

LightCycler 480 System II

Rotor-Gene Q

CFX96
Status For in vitro diagnostic use, CE marking in Europe- Please enquire

 

 

Bordetella parapertussis R-GENE (71-012)

Bordetella parapertussis R-GENE (71-012)
Principle of the test Genomic detection of Bordetella parapertussis
Ordering information Reference 71-012: Bordetella parapertussis R-GENE kit
Technology Real-Time PCR / 5‘ nuclease Taqman technology
Gene target IS1001 region
Specimen* Nasopharyngeal aspirations and expectorations
Controls included Extraction + Inhibition control, Negative control, Positive control
Results within 75 minutes (extraction step not included)
Reporting unit Qualitative test
Number of tests 60 tests
Storage conditions -15°C/-31°C
Validated Extraction platform* EMAG®

NUCLISENS easyMAG®
Validated Amplification platform* ABI7500 Fast, ABI 7500 Fast Dx

LightCycler 480 System II

Rotor-Gene Q

CFX96
Status For in vitro diagnostic use, CE marking in Europe- Please inquire

* please enquire

 

SARS-COV-2 RESPI R-GENE® (423732)

SARS-COV-2 RESPI R-GENE® (423732)
Ordering information SARS-COV-2 RESPI R-GENE® - Ref.: 423732
Kit content

All included

Positive controls, Negative Control, Cell control

Gene targets

PCR1 (96 tests)

SARS-CoV-2 : N & RdRp (670 nm)

Influenza A : M gene (530 nm)

Influenza B : M gene (560 nm)

Cell control : HPRT1 (610 nm)

PCR2 (96 tests)

RSV A/B : N gene (530 nm)

hMPV A/B : M gene (560 nm)

Number of tests 96 tests
Validated Specimen Nasopharyngeal swabs
Validated Platforms Extraction Amplification
  • EMAG®
  • NUCLISENS® easyMAG®
  • MGISP-960
  • QIAsymphony SP
  • MagNA Pure 96
  • ABI 7500 Fast
  • ABI 7500 Fast Dx
  • QuantStudio 5
  • QuantStudio 5 Dx
  • CFX96
Shelf Life 12 months at launch
Regulatory Status For In vitro Diagnostic use (CE-IVD)
Storage conditions -15°C / -31°C

 

COVID-19 R-GENE® (424017) - Real Time Detection kit
Principle of the test Genomic detection of SARS-CoV-2
Ordering information Reference: 424017

Designation: COVID-19 R-GENE® - Real Time Detection kit
Technology Real-Time PCR / 5’ nuclease technology
PCR design & Gene target
  • SARS-CoV-2 N gene (FAM)
  • SARS-CoV-2 RdRp gene (CY5)
  • Endogenous Internal Control HPRT1 gene (HEX)
Specimen
  • Nasopharyngeal swabs
  • Saliva
Controls included Negative Control, Positive Control, Endogenous Internal Control
Number of tests 96 tests
Storage conditions -15°C/-31°C
Extraction platform
  • EMAG®
  • NUCLISENS® easyMAG®
  • MagNA Pure 96
  • QIAsymphony SP
  • MGISP-960
Amplification platform
  • LightCycler 480 (System II)
  • ABI 7500 Fast, ABI 7500 Fast Dx
  • QuantStudio5, QuantStudio5 Dx
  • Rotor-Gene Q
  • CFX96, CFX Opus 96
Status For In vitro Diagnostic use (CE-IVD)

 

Fast facts on Respiratory Pathogens

What are Respiratory Pathogens?

The vast majority of respiratory illnesses are caused by viruses and bacteria. In both children and adults, acute respiratory infections (ARI) are most frequently due to infections with Influenza A and B viruses, Parainfluenza viruses 1, 2 and 3, Respiratory Syncytial Virus (RSV A and B), Adenoviruses and Rhinoviruses. Others pathogens such as Coronaviruses, Bocaviruses, Enteroviruses, Parainfluenza 4, human Metapneumovirus, Mycoplasma pneumoniaChlamydia pneumoniae, Legionella pneumophila, Bordetella pertussis and Bordetella parapertussis also infect the respiratory tract and can cause various diseases from mild self-limiting upper respiratory infections to potentially threatening pneumonia.

Who is most at risk?

Anyone can become infected and ill with these respiratory pathogens. However, young children, the elderly, immunocompromised or weakened individuals (including those with chronic disease, cancer, or in intensive care) are most likely to suffer serious and potentially life-threatening pneumopathies.

What are the benefits of Respiratory pathogens molecular testing?

Clinical symptoms for different respiratory illnesses are similar so in vitro diagnostic molecular methods are necessary to determine the causative agents. Early, rapid and specific detection of the virus or bacteria involved using real-time PCR methods is essential to provide patient-tailored therapy for better outcomes. An accurate diagnosis will also help to control outbreaks, reduce potential antibiotic resistance and facilitate a more rapid patient recovery.

ARGENE® Respiratory: PUBLICATIONS & POSTERS

Infections respiratoires aigües : étude comparative des trousses d’amplification génique en temps réel respiratory multi well system r-gene de BioMérieux et Respiratory pathogens 21 de Fast Track diagnostics.

Trombert-Paolantoni S., Hedbaut E., Clairet V

RICAI 2015

 

Pattern of Respiratory Pathogen Nasal Colonization in the first year of life in Healthy Infants and Infants with Cystic Fibrosis

Insa Korten et al.

Poster ESCV 2016

 

BioMérieux molecular workflow : solution for ARGENE® product range automation

Bourdin Jérôme; Levillain Erwan; Bes Jérôme; Guy Michel; Margry Pascal; Bufflier Emmanuel; Chini Giorgio; Pradier Nicolas; Magro Stephane; Brengel-Pesce Karen

Poster ESCV 2014

Development of a new MWS r-gene Real Time PCR for the detection of Legionella pneumophila

Cécile Résa; Bertrand Marina; Dubé Manon; Pourqué Laure ; Magro Stéphane , Barranger Côme and Joannes Martine

ESCV 2014


 

bioMérieux Argene Range verifications on the ViiA7 (Fast and Standard Blocks) and ABi 7500 Fast Dx Real Time PCR Platforms

(Magro Stephane; Delarivière Audrey; Berriot Aurelie; Turc Amelie; Moiroud Elise; Derome Andrew; Alberti-Segui Cristina; Grosz Sophie; Vidal Celine; Poyet-Gelas Fanny and Barranger Come)

ESCV 2014


 

Mobile phone use in health care units as potential vectors of viral infections

Sylvie Pillet et al, University Hospital Saint-Etienne

ESCV 2014


 

Comparative Evaluation of Six Commercialized Multiplex PCR Kits for the Diagnosis of Respiratory Infections

Pillet et al.

PLOS 2013.


 

Use of of Influenza Duplex PCR according Lean management to improve response to influenza pandemic and epidemic surge in a hospital virology department.

Casalegno JS, Bouscambert M, Valette M, Billaud G, Emilie F, Escuret V, Mekki Y, Morfin F, Lina B.

HCL Lyon & Laboratoire de Virologie Lyon-Est, Bron, France

Option VIII, Cape Town, South Africa 2013


 

Evaluation des performances de la trousse Chla/Myco pneumo r-gene (Argène/bioMérieux) pour la détection de Mycoplasma pneumoniae par PCR en temps réel

Tanguy Flao et al.

USC Infections humaines à mycoplasmes et à chlamydiae, CNR des infections à chlamydiae

RICAI 2013


 

Respiratory Viruses In Hospitalised Adults In Bern, Switzerland During The 2012/2013 Season

Maria Teresa Barbani et al

Institute for Infectious diseases, University of Bern, Switzerland

ECV 2013


 

Identification Of Viral Pathogens Responsible For Severe And Complicated Respiratory Infection During The Pandemic And Post-Pandemic Period (2009-2011)

Marta Canuti et al.

Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.

ECV 2013


 

Development of a new diagnostic tool for the detection of Human Coronaviruses & Human Parainfluenzaviruses in a duplex RT PCR

Jérôme Bes et al.

bioMérieux.

ECV 2013


 

Development of a new diagnostic tool for the detection of Rhinovirus/Enterovirus and Cellular control in a duplex RT PCR

Bes et al. ARGENE.

Europic 2012


 

Development of a new diagnostic tool for the detection of Chlamydophila pneumoniae and Mycoplasma pneumoniae in a duplex real-time PCR

Bertrand et al.

ARGENE.

ECCMID 2012


 

Respiratory Multi Well System (MWS) r-gene™ : simultaneous detection of infectious agents involved in respiratory diseases

Magro et al.

ARGENE.

CVS 2011


 

Respiratory Multi Well System (MWS) r-gene™ : simultaneous detection of infectious agents involved in respiratory diseases

Résa et al.

ARGENE.

ESCV 2011


 

Development of a new diagnostic tool for the detection of Chlamydophila pneumoniae and Mycoplasma pneumoniae in a duplex real-time PCR

Bertrand et al.

ARGENE.

ESCV 2011


 

 

Please consult your local bioMérieux representative for product availability in your country

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