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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 MWSR-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/BR-GENE®
- RSV/hMPVR-GENE®
- Rhino&EV/CcR-GENE®
- AdV/hBoVR-GENE®
- Chla/Myco pneumoR-GENE®
- HCoV/HPIVR-GENE®
- - NEW - Legio pneumo/CcR-GENE®
Respiratory MWSR-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 MWSR-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 EASYSTREAMTM* liquid handling system
- Qualified with the major real-time PCR platforms
*Coming soon
A complete kit with all you need
Respiratory MWSR-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 MWSR-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”.
BIOMERIEUX, the blue logo, ARGENE®,R-GENE®, EASYMAG® andNUCLISENS® 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 | -18°C/-22°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 | -18°C/-22°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 | -18°C/-22°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 | -18°C/-22°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 | -18°C/-22°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 | -18°C/-22°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 | -18°C/-22°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
- 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 - Comparative Evaluation of Six Commercialized Multiplex PCR Kits for the Diagnosis of Respiratory Infections
Sylvie Pillet1., Marina Lardeux1., Julia Dina2, Florence Grattard1, Paul Verhoeven1, Jérôme Le Goff3,Astrid Vabret2, Bruno Pozzetto1*
August 2013 | Volume 8 | Issue 8 | e72174
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