RESPIRATORY INFECTIONS TESTING AdV RSV EBV hmpv HSV IB Chlamydophila pneumoniae RHINO EV HPIV Legionella pneumophila HCoV IA Mycoplasma pneumoniae HBoV Bordetella pertussis VZV CMV Respiratory Multi Well System (MWS) r-gene DETECTED PARAMETERS: Infl uenza A Infl uenza B Human Coronavirus (229E, NL63, HKU1, OC43) Respiratory Syncytial Virus (A,B) Human Metapneumovirus (A,B) Parainfl uenza virus (1,2,3,4) Rhinovirus (A,B,C) Enterovirus (A,B,C,D) Adenovirus (A,B,C,D,E,F,G) Bocavirus (1,2,3,4) Chlamydophila pneumoniae Mycoplasma pneumoniae Bordetella pertussis Bordetella parapertussis Legionella pneumophila HSV VZV CMV EBV HHV6 Cell Control
FEATURES Respiratory Multi Well System (MWS) r-gene is a comprehensive range of complete real-time PCR kits for the detection of respiratory pathogens. Respiratory MWS r-gene allows the detection of numerous pathogens in the same run. CLINICAL CONTEXT Acute respiratory infections are responsible for numerous hospitalizations of children and are mainly caused by bacterial or viral pathogens. The most serious and potentially life-threatening pneumopathies are mainly found in young children, in the elderly, in immunocompromised or weakened individuals (chronic disease, cancer, intensive care unit). Establishing a fast and reliable emergency diagnosis is essential for the management of the patients (with an adaptated antibiotherapy for example) and to prevent the spread of infection. Since symptomatologies are similar, the identifi cation of infectious agents need appropriate diagnostic testing. Conventional culture methods are not conclusive, because some viruses and intracellular bacteria cannot be cultured or can only be cultured with extreme diffi culty. Multiplex detection allows the diagnosis of dual or even triple infections, which can have consequences on the severity of the disease and on the therapeutic strategy. Respiratory pathogens have variable seasonalities : some are present throughout the year whereas others are found only during the epidemic outbreaks. Hence, diagnostic strategies can be adapted to the season (winter / summer workfl ow) : searching for the most likely pathogens can be considered in 1 st intention, the remaining pathogens being searched for systematically in 2 nd intention. Rapid diagnostic tests reduce hospital expenses and avoid the risk of inappropriate therapy. SCREENING Complete kits using 5 nuclease TaqMan technology for the fast and reliable detection of various pathogens with respiratory tropism. Possibility of simultaneous detection of the following viruses: CMV, EBV, HSV1, HSV2, VZV, HHV6... thanks to a common amplification program with MWS r-gene. FLEXIBILITY MWS r-gene ADVANTAGES Possibility to choose from one to more than 40 pathogens corresponding to chosen combinations. «à la carte» diagnosis according to a common protocol for DNA or RNA pathogens. Results in less than 1h45 after extraction. Possibility to have several runs in the same day. Possibility to search for viruses and bacteria together or separately. SENSITIVITY & ACCURACY Presence of a cellular control to validate the quality of the sample and the entire process. Presence of a positive control, a negative control and an internal control (extraction/inhibition) with Bordetella R-gene kit. High sensitivity thanks to duplex testing. CONCLUSION MWS r-gene is a fast, reliable and easy-to-use diagnostic tool for the detection of bacterial and/or viral pathogens by real-time PCR. MWS r-gene is a unique solution for an efficient patient management and for the prevention of nosocomial infections.
MWS R-gene FEATURES MWS r-gene FEATURES Several complete kits «à la carte» testing Multiple target detection 5 nuclease technology Universal conditions Ready-to-use reagents MWS r-gene Detection of the DNA pathogens - AdV/hBoV r-gene - Chla/Myco pneumo r-gene Contents of the kits Specific amplification premix Negative control (molecular grade water) Pathogen-specific positive control MWS r-gene Detection of the RNA pathogens* - Infl uenza A/B r-gene - RSV/hMPV r-gene - Rhino&EV/Cc r-gene - HCoV/HPIV r-gene Contents of the kits Reverse Transcriptase Specific amplification premix Negative control (molecular grade water) Pathogen-specific positive control Designation Influenza A/B RSV/hMPV Rhino&EV/Cc AdV/hBoV Chla/Myco pneumo HCoV/HPIV r-gene r-gene r-gene r-gene r-gene r-gene Ref. 71-040 Ref. 71-041 Ref. 71-042 Ref. 71-043 Ref. 71-044 Ref. 71-045 Principle of the Test Duplex Detection of Respiratory Pathogens by Real-time PCR Technology 5 nuclease Technology TaqMan Gene Target Infl uenza A: RSV: Rhino&EV: Adenovirus: C. Pneumoniae: HCoV M Gene Coding for M Gene Coding for 5 Non Coding Hexon Gene Gene OMP2 Coding N Gene coding for matricial protein Nucleus Protein Region for membran nucleus protein surface protein Infl uenza B: hmpv: Cell Control: Bocavirus M. Pneumoniae HPIV M Gene Coding for M Gene Coding for HPRT1 Gene NS1 and VP1 P1 Gene Coding N Gene coding for matricial protein matricial protein Genes for Cytadhesine a nucleus protein Detected Strains Infl uenza A RSV A, RSV B, hmpv A Rhinovirus A,B, C AdV A, B, C, D, E, F, G Chlamydophila Coronavirus humain Infl uenza B hmpv B Enterovirus A, B, C, D hbov 1, 2, 3, 4 Pneumoniae 229E, NL63, HKU1, OC43 Mycoplasma Parainfl uenza Pneumoniae 1, 2, 3, 4 Specimen Respiratory Sample Controls included Positive Control, Negative Control, Cell Control** Result Within 1h30 after extraction Number of Tests 60 tests Kit Storage -18 C/-22 C Validated Equipments Extraction: NucliSENS easymag (biomérieux) Amplifi cation: ABI 7500 Fast (Applied Biosystem), MagNA Pure Compact (Roche Diagnostics), QIAsymphony (Qiagen) Dx Real-Time System (Bio-Rad), StepOne (Applied Biosystems) LC480 (Roche), Stratagene/Agilent/Versant kpcr AD Rotor-Gene (Qiagen) Status For in vitro diagnostic use, CE marking in Europe - Please inquire USA: for Research use only. Not for use in diagnostic Procedures * This product contains SuperScript III Reverse Transcriptase that is the subject of one or more issued US patents or pending US patent applications, and corresponding non-us equivalents, owned by Life Technologies Corporation, and is sold under an agreement between Life Technologies Corporation and Argene. The purchase price of this product includes limited, nontransferable rights under the foregoing patents to use this amount of the product to practice the claims in said patents solely for activities of the purchaser in detection of human viruses for diagnostic purposes. No other rights are conveyed, including no right to use this product for applications in forensics. Further information about acquiring rights under patents owned by Life Technologies Corporation may be obtained by contacting the Licensing Department, Life Technologies Corporation, 5791 Van Allen Way, Carlsbad, CA 92008. (760) 603-7200. email: outlicensing@lifetech.com» ** Only in kit 71-042.
KEY POINTS of real-time PCR ARGENE kits MWS r-gene Multiplex PCR enables the detection of all respiratory pathogens according to your specific combination! Easy to Use Ready-to-use reagents One step RT PCR Most commonly used technique in many laboratories Color codes allow for a quick identification of products and reagents Fast and easy set up Fast & Convenient Other R-gene kits... The already available R-gene kits for other pathogens can be used with the same protocol as the new MWS r-gene kits. Detection of more than 40 pathogens Common amplification program for DNA and RNA pathogens Results within 2h30 hours from sample treatment to results Possibility to test one or various pathogens according to your choice of parameters Reliable CE marked Manufacturing according cgmp rules Accuracy and robustess of a TaqMan 5 nuclease assay A close single-tube reaction Standardized assays with positive, negative and cell controls provided - CMV R-gene - CMV HHV6, 7, 8 R-gene - Adenovius R-gene - HSV1, HSV2, VZV R-gene - EBV R-gene Versatile Validated for use on multiple extraction systems Qualified with the major Real-Time PCR platforms Designed for low to high throughput analysis. Validated on various types of samples - BK Virus R-gene - Enterovirus R-gene - Bordetella R-gene - Bordetella parapertussis r-gene
Principle of MWS r-gene kits Sample 10µLExtracted 10µL Positive control + 10µLExtracted Water Negative control 15µL Amplification premix 15µL Amplification premix 15µL Amplification premix 530nm 560nm Pathogen 1 Pathogen 2 or Cell Control 530nm Pathogen 1 560nm Pathogen 2 ou Cell Control 530nm 560nm Pathogen 1 Pathogen 2 or Cell control NB: MWS can also be used with DICO Extra r-gene or RICO Extra r-gene CELL CONTROL The CELL Control r-gene kit 71-106 is a diagnostic tool to check and quantify the presence of cells in samples, by detection of the housekeeping gene HPRT1. Associated with a viral quantification, the final result can be expressed in relative quantification, in copies of target virus per cells in the sample and allow to compare successive results from the same patient for a follow-up of treatment.
08-12 / 9304072/007/GB/A / This document is not legally binding. biomérieux reserves the right to modify specifications without notice. BIOMERIEUX, the blue logo, ARGENE, easymag, NucliSENS, R-gene and MWS r-gene are used, pending and/or registered trademarks belonging to biomérieux S.A. or one of its subsidiaries or one of its companies. The storage box is a used, pending and/or registered design belonging to biomérieux or one of its subsidiaries or one of its companies. biomérieux SA RCS Lyon 673 602 399 / Photos: Getty Images, GraphicObsession / Printed in France / THERA Conseil / RCS Lyon B 398 160 242 PRODUCT NAME NUMBER OF TESTS REF Respiratory pathogens detection Infl uenza A/B r-gene 60 tests 71-040 RSV/hMPV r-gene 60 tests 71-041 Rhino&EV/Cc r-gene 60 tests 71-042 AdV/hBoV r-gene 60 tests 71-043 Chla/Myco pneumo r-gene 60 tests 71-044 HCoV/HPIV r-gene 60 tests 71-045 Bordetella R-gene 60 tests 69-011B Bordetella parapertussis r-gene 60 tests 71-012 Infl uenza A (M) Group&H1N12009 r-gene 60 tests 71-300 R-gene kits HSV1 HSV2 VZV R-gene 180 tests 69-004B EBV R-gene 90 tests 69-002B CMV HHV6,7,8 R-gene 140 tests 69-100B CMV R-gene 90 tests 69-003B BK Virus R-gene 90 tests 69-013B Enterovirus R-gene 90 tests 69-005B Adenovirus R-gene 90 tests 69-010B Complementary products CELL Control r-gene 60 tests 71-106 DICO Extra r-gene 60 tests 71-101 RICO Extra r-gene 60 tests 71-105 Quanti FluA QS r-gene 30 tests 68-006 biomérieux also offers a complete ARGENE range of immunology products. For any additional information please don t hesitate to contact our sales team! biomérieux manufactures its reagents in compliance with cgmp and ISO 13485 for optimal product quality and consistent results. biomérieux has entered into a license agreement covering real-time PCR technology with F.Hoffmann-La Roche Ltd and Roche Molecular Systems, Inc. Therefore the purchase of these products grants the purchaser rights under certain Roche patents to use them solely for human in vitro diagnostic testing servies. No general patent or other license of any kind other than this specifi c right of use from purchase is granted hereby by Argene. For in vitro diagnostic use, CE marking in Europe - Please inquire. USA: For research use only. Not for use in diagnostic procedures. biomérieux S.A. 69280 Marcy l Etoile France Tel. : +33 (0)4 78 87 20 00 Fax : +33 (0)4 78 87 20 90 www.biomerieux.com www.biomerieux-diagnostics.com www.argene.com