Respiratory Multi Well System MWS R-GENE® 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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Respiratory MWS R-GENE® menu

What could be easier? The Respiratory MWS R-GENE® 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:

  • Influenza A/B R-GENE®
  • RSV/hMPV R-GENE®
  • Rhino&EV/Cc R-GENE®
  • AdV/hBoV R-GENE®
  • Chla/Myco pneumo R-GENE®
  • HCoV/HPIV R-GENE®
  • Legio pneumo/Cc R-GENE®

 

Respiratory MWS R-GENE® 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 Respiratory MWS R-GENE® 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®, as well as user-friendly assay setup techniques such as EASYSTREAM™* liquid handling system
    • Qualified with the major real-time PCR platforms

*Coming soon

A complete kit with all you need

Respiratory MWS R-GENE® 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 Respiratory MWS R-GENE® 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”.

Principle of MWS r-gene® kits

Click to enlarge 

 

 

BIOMERIEUX, the blue logo, ARGENE®, R-GENE®, EASYMAG® and NUCLISENS® 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
Limit of Detection (On DX Real-Time System (Bio-Rad)) Influenza A: LoD 95% : 199.5 TCID50/mL
Influenza B: LoD 95% : 1 1.7 TCID50/mL
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* NUCLISENS® EASYMAG®
MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* Applied Biosystems 7500 Fast, StepOne
Dx Real-Time System
LightCycler 480 System II
Stratagene / Agilent/ VERSANT kPCR Molecular System AD
RotoR-GENE
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
Limit of Detection (On DX Real-Time System (Bio-Rad)) hMPV A : LoD 95% : 2041.7 TCID50/mL
hMPV B : LoD 95% : 4466.8 TCID50/mL
RSV A : LoD 95% : 2.0 TCID50/mL
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 NUCLISENS® EASYMAG®
MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* LightCycler 480
System II RotoR-GENE
Applied Biosystems 7500 Fast, StepOne
Stratagene / Agilent / VERSANT kPCR Molecular System AD
Dx Real-Time System
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)
Limit of Detection Nasopharyngeal sample: Rhinovirus 14 LoD 95%: 0.43 TCID50/mL
Nasopharyngeal sample :Enterovirus (echovirus 25) LoD 95%: 37.96 TCID50/mL
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 NUCLISENS® EASYMAG®
MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* LightCycler 480 System II
RotoR-GENE
Applied Biosystems 7500 Fast, StepOne
Stratagene / Agilent/ VERSANT kPCR Molecular System AD
Dx Real-Time System
VERSANT kPCR Molecular System AD
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)
Limit of detection Nasopharyngeal sample AdV3 : LoD 95% : 800 Copies /mL
Nasopharyngeal sample hBoV1 : LoD 95% : 900 Copies /mL
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 NUCLISENS®
EASYMAG® MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* LightCycler 480 System II RotoR-GENE Applied Biosystems 7500 Fast, StepOne Stratagene / Agilent / VERSANT kPCR Molecular System AD Dx Real-Time System
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)
Limit of detection Chlamydia pneumoniae : LoD 95% : 0.26 IFU/mL
Mycoplasma pneumoniae : LoD 95% :  200 CCU/mL
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 NUCLISENS® EASYMAG®
MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* LightCycler 480 System II
RotoR-GENE
Applied Biosystems 7500 Fast, StepOne
Stratagene / Agilent / VERSANT kPCR Molecular System AD
Dx Real-Time System
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
Limit of detection Coronavirus 229E : LoD 95% : 0.20 TCID/50mL
Coronavirus OC43 : LoD 95% : 86.85 TCID/50mL
Coronavirus NL63 : LoD 95% : 0.002 TCID/50mL
Coronavirus HKU1 : LoD 95% : 18.07 Copies/mL
Parainfluenza 1 : LoD 95% : 379.79 TCID/50mL
Parainfluenza 2 : LoD 95% : 529.93 TCID/50mL
Parainfluenza 3 : LoD 95% : 245.28 TCID/50mL
Parainfluenza 4 : LoD 95% : 0.21 TCID/50mL
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 NUCLISENS® EASYMAG®
MagNA Pure Compact
QIAsymphony SP
Validated Amplification platform* LightCycler 480
RotoR-GENE
Applied Biosystems 7500 Fast, StepOne
Stratagene / Agilent / VERSANT kPCR Molecular System AD
Dx Real-Time System
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
Limit of detection
on Dx Real-Time System (Bio-Rad):
Legionella pneumophila: LoD 95% : 48.3 CFU/mL
 
on ABI 7500 Fast (Applied Biosystems):
Legionella pneumophila: LoD 95% : 58.2 CFU/mL
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 NUCLISENS® EASYMAG®
MagNA Pure Compact
Validated Amplification platform*
Applied Biosystems 7500 Fast, Fast 7500 Fast Dx, ViiA7 (blocks for 96 well and  Fast  96 well plates), StepOne
LightCycler 480 System II
 
RotoR-GENE
 
Dx Real-Time System
Stratagene / Agilent/ VERSANT kPCR Molecular System AD
 
Status For in vitro diagnostic use, CE marking in Europe

*Please enquire

 

 

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 pneumonia and Chlamydiae pneumonia 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.

Respiratory MWS R-GENE®: PUBLICATIONS & POSTERS

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

 

 

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