All products for:Argene Bacteria&Fungi Molecular diagnostics Respiratory Tract Infections

BORDETELLA R-GENE^®& Bordetella parapertussis R-GENE

Real-time PCR kits offering qualitative detection of Bordetella pertussis DNA with the BORDETELLA R-GENE® and of Bordetella parapertussis DNA with Bordetella parapertussis R-GENE®

Ready-to-use kits that include internal, positive & negative controls
Perform both tests on the same sample & during the same PCR run
CE-IVD on all major extraction platforms and real-time PCR systems and on different respiratory samples types

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BORTEDELLA R-GENE^®& Bordetella parapertussis R-GENE advantages

Pertussis, commonly known as whooping cough, is an upper respiratory infection caused by Bordetella pertussis. Bordetella parapertussis causes a bacterial illness similar to whooping cough, although typically milder. Optimized detection of Bordetella infection is critical to ensure the best patient management. BORDETELLA R-GENE^® offers rapid and specific detection of Bordetella bacteria containing the IS481 sequence, most commonly found in Bordetella pertussis. Similarly, Bordetella parapertussis R-GENE is designed for the detection of IS1001 region of Bordetella parapertussis.

Both assays can be performed on respiratory samples (nasopharyngeal aspiration and expectoration). For even more optimized and comprehensive testing, you can use the Respiratory Multi Well System M.W.S. R-GENE^® range to detect various respiratory viruses and bacteria from one sample or analyze various samples for one virus at the same time.

Sensitive and reproducible
- Reliable detection of Bordetella pertussis and Bordetella parapertussis infection
- All controls included

Standardized
- Uniform processing with Respiratory M.W.S. R-GENE^® range of products (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)
- Harmonized test profiles for multiple assays in one run
Flexible
- Validated for use with various samples types
- Qualified for manual use or with automated sample preparation such as NucliSENS^® easyMAG^® and assay setup platforms such as easySTREAM^®liquid handling system
- Qualified with the major real-time PCR platforms

Complete kit with all you need

BORDETELLA R-GENE^® and Bordetella parapertussis R-GENE are ready-to-use kits that detect the presence of Bordetella pertussis and Bordetella parapertussis using real-time PCR after viral DNA extraction. This 5’ nuclease-based Taqman technology amplifies and simultaneously detects a specific region of the bacterial genome.

An Internal Control (IC2) checks the extraction process, including lysis, and the presence of amplification inhibitors in the sample
Positive and Negative controls
Each kit Includes all necessary reagents optimized to detect either Bordetella pertussis or Bordetella parapertussis for in vitro diagnostic use

Simple procedure

Using BORDETELLA R-GENE^®and Bordetella parapertussis R-GENE kits is simple. Just add the extracted DNA sample to the ready-to-use PCR master mix 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^® 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.

BORDETELLA R-GENE® (69-011B)
Principle of the test	Genomic detection of Bordetella pertussis
Ordering information	Reference 69-011B: BORDETELLA R-GENE^®kit Also available under reference 69-011 : BORTEDELLA R-GENE^® COMPLETE kit (including ref. 69-011B and ref. 67-000 DNA extraction kit)
Technology	Real-Time PCR / 5‘ nuclease Taqman technology
Gene target	IS481 region
Specimen*	Nasopharyngeal aspirations and expectorations
Limit of detection	LoD 95% : 250 bacteria/mL Detection limit is 10 bacterial genome/ mL
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	-18°C/-22°C for reference 69-011B (Amplification/Detection kit), +2°C/+8°C for ref. 67-000 (DNA extraction kit)
Validated Extraction platform* Manual Automated	QIAamp DNA Blood Mini kit High Pure PCR template preparation kit NucliSENS^® easyMAG^® MagNA Pure Compact MagNA Pure LC QIAcube
Validated Amplification platform*	Applied Biosystems LightCycler SmartCycler 2.0 RotoR-GENE Dx Real-Time system
Status	For in vitro diagnostic use, CE marking in Europe- Please enquire
	USA: for research only. Not for use in diagnostics procedures (ref. 69-011B-01)

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
Limit of detection	LoD 95%: 22 bacterial genome/ mL
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	-18°C/-22°C for reference 71-012
*Validated Extraction platform Manual Automated**	QIAamp DNA Blood Mini kit High Pure PCR template preparation kit NucliSENS^® easyMAG^®MagNA Pure Compact MagNA Pure LC QIAcube
Validated Amplification platform*	Applied Biosystems (ABI7900, 7500Fast, StepOne) LightCycler 2.0, LightCycler 480 SmartCycler 2.0 RotorGene Dx Real-Time system Stratagene/ Agilent / Versant kPCR Molecular Systems AD
Status	For in vitro diagnostic use, CE marking in Europe- Please inquire USA: for research only. Not for use in diagnostics procedures (ref. 71-012-01)

* please enquire

Fast facts on Bordetella pertussis and Bordetella parapertussis

What are Bordetella pertussis and Bordetella parapertussis?

Pertussis, known as whooping cough, is a highly contagious respiratory illness that mainly affects children under 5 years old. It is caused by the Gram-negative bacterial pathogen Bordetella pertussis, one of nine species of Bordetella identified today. This pathogen produces pertussis toxin, leading to inflammatory and necrotic impairment.
Bordetella parapertussis has been identified as responsible for an attenuated form of whooping cough, called Parapertussis. These bacteria enter the body through the airways and attach to the mucosa of the upper respiratory tract (trachea and bronchi).

Who is most at risk?

Infection by Bordetella pertussis may be very serious – even fatal – in infants under 6 months, because they have no immunity against the illness (maternal antibodies against whooping cough do not cross the placenta). The disease can then lead to respiratory complications (apnea and bacterial surinfections). Whooping cough can, however, cause illness in people of any age. Approximately 40% of cases may be asymptomatic. In well-vaccinated countries, mortality and morbidity have been reduced by 95%. However, a change in the transmission mode of the disease has been observed for some years in the absence of natural or vaccination boosting. It is no longer transmitted only among children, but from adult or adolescent to non-vaccinated infants.