CMV HHV6,7,8 R-gene®

Real-time PCR kit for the detection and quantification of CMV, HHV-6, and identification of HHV-7 and HHV-8 DNA

  • Accurate quantification of CMV & HHV-6 viral load over a wide linear range
  • Qualitative detection of HHV-7 and HHV-8
  • Ready-to-use kit including internal control and quantification standards for CMV and HHV-6
  • CE-IVD on all major extraction platforms and real-time PCR
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CMV HHV6,7,8 R-gene® advantages

CMV, HHV-6, HHV-7, HHV-8 are responsible for a wide range of pathologies. That’s why it’s important to achieve optimized detection and monitoring of CMV, HHV-6, HHV-7 and HHV-8 infection. CMV HHV6,7,8 R-gene® is an ideal solution, offering rapid and specific detection. You can detect infection prior to clinical symptoms, improving options for management; test patients during treatment to measure the effectiveness of treatment; and test after treatment to monitor for relapse. Plus – for added efficiency and comprehensiveness – use with many of the kits from the R-gene® range allows you to detect various viruses from one sample or analyze various samples for one virus at the same time.

  • Sensitive and reproducible
    • Reliable detection of CMV and HHV6; identification of HHV-7, HHV-8 infection
    • Wide linear range for CMV and HHV-6 viral load
  • Standardized
    • Harmonized test profiles for multiple assays in one run
    • Uniform processing with R-gene® range of products (CMV R-gene®, HSV1 HSV2 VZV R-gene®, BK Virus R-gene®, Adenovirus Virus R-gene®, EBV R-gene®, Parvovirus B19 R-gene®)
  • Flexible
    • Validated for use with various samples types
    • Prepare samples manually or use automated sample preparation such as NucliSENS® easyMAG® and assay setup platform such as easySTREAMTM* liquid handling system
    • Qualified with the major real-time PCR platforms

*coming soon

Everything you need in one kit

The CMV HHV6,7,8 R-gene® assay is a ready-to-use molecular detection kit. Using real-time PCR after viral DNA extraction, it measures the viral load of CMV and HHV-6, and allows the detection of HHV-7 and HHV-8. It works by amplifying and simultaneously detecting specific regions of the CMV, HHV-6, HHV-7 and HHV-8 genomes using 5’ nuclease Taqman technology.

  • Four Quantification Standards ensure accurate measurement of CMV and HHV-6 viral loads
  • A sensitivity Control validates the performance of the assay
  • An Internal Control (IC2) checks the extraction process, including lysis, and the presence of amplification inhibitors in the sample
  • Includes all necessary reagents optimized to quantify CMV (90 tests), HHV-6 (30 tests) & detect HHV-7 (10 tests), HHV-8 (10 tests) for in vitro diagnostic use.
  • Additional reagents: increase your PCR test numbers with HHV6 premix r-gene® (69-100R6 – 60 tests), HHV7 premix r-gene® (69-100R7 - 20 tests), HHV8 premix r-gene® (69-100R8 - 20 tests).

Easy procedure

The CMV HHV6,7,8 R-gene® kit is simple to use. Just add the extracted DNA sample to the ready-to-use PCR master mixes and start the reaction on the appropriate Real-Time PCR thermocycler, following optimized cycling program described in the “Instructions For Use”.

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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.

Technical Specifications - CMV HHV6,7,8 R-gene® (69-100B
Principle of the test Genomic detection and quantification of CMV and HHV-6
Genomic detection of HHV-7 and HHV-8
Ordering information Reference 69-100B: CMV HHV6,7,8 R-gene® Detection and Quantification kit
Also available under reference 69-100: CMV HHV6,7,8  R-gene® Detection and Quantification kit
 COMPLETE kit (includes 69-100B Detection and Quantification kit
 kit and ref. 67-000 DNA Extraction kit)
 Supplementary reagents:
 69-100R6: HHV6 premix r-gene®
 
69-100R7: HHV7 premix r-gene®
 
69-100R8: HHV8 premix r-gene®
Technology Real-Time PCR /  5‘ nuclease Taqman technology
Gene target CMV: gene coding for ppUL83 protein
HHV-6: U57 gene
HHV-7: U42 gene
HHV-8: ORF26 gene
Specimen* Whole blood, Plasma, CSF, Amniotic  Fluid, Serum, Urine, BAL, Biopsies
Limit of Detection CMV: LoD 95% : 446 Copies/ mL of whole blood sample
HHV-6: LoD 95% : 555 Copies/mL of whole blood  sample
Dynamic Range of Quantification CMV in whole blood sample: 9.43 log (Cp/mL) to 2.63 log Cp/mL)
CMV in Amniotic Fluid sample: 9.43 log (Cp/mL) to 2.63 log Cp/mL)
Controls included Extraction + Inhibition control, Sensitivity control, negative control
Results within 75 minutes (extraction step not included)
Reporting unit Copies/mL
Number of tests 140 tests
Storage conditions -15°C/-31°C for reference 69-100B (Detection and Quantification kit) +2°C/+8°C for ref. 67-000 (DNA Extraction kit)
Validated Extraction platform*
Manual
Automated
QIAamp DNA Blood Mini kit
QIAcube
NucliSENS® easyMAG®
MagNA Pure Compact
MagNA Pure LC
MagNA Pure 96
m2000sp
VERSANT kPCR Molecular System SP
QIAsymphony SP
Validated Amplification platform* Life Technologies (Applied Biosystems)
LightCycler 1.0
LightCycler 2.0
LightCycler 480 System II
RotorGene
VERSANT kPCR Molecular System AD
DX Real-Time system
CFX96
Stratagene / Agilent
Status For in vitro diagnostic use, CE marking in Europe:

* please inquire

Fast facts on CMV, HHV-6, HHV-7 and HHV-8 Virus

What are CMV, HHV-6, HHV-7, HHV-8?
Cytomegalovirus (CMV), human herpesevirus-6 (HHV-6), human herpesevirus-7 (HHV-7) and human herpesevirus-8 (HHV-8) are viruses characterized by high seroprevalence (ranging from 50% to 100%, depending on the geographical region) that are responsible for a wide range of pathologies. The primary infection commonly occurs during young childhood. The viral dissemination in blood may lead to benign and rare clinical signs. CMV, HHV-6, HHV-7 and HHV-8 establish a lifelong dormant infection. However, the viruses often reactivate in the case of an immunosuppression.

Who is most at risk?
The severity of infection depends on the immune status of the host (e.g. AIDS patients and organ transplant patients are commonly known as fragile hosts). CMV is associated with neurological diseases and pneumopathy. In severe cases, it can lead to mortality in immunocompromised patients. HHV-6 and HH-7 are also very likely to be involved in opportunistic infections in immunocompromised patients. HHV-6 and HHV-7 most likely increase the secondary CMV infections through a process of cross reactivation. When primary infection occurs, HHV-6 is also suspected to be responsible for mononucleosic syndroma, lymphadenopathy and hepatitis. HHV-8 is associated with lymphoproliferative diseases such as Kaposi sarcoma, Castleman disease and some lymphomas.

What are the benefits of CMV, HHV-6, HHV-7, HHV-8 testing?
Real-Time PCR-based assays for CMV, HHV-6, HHV-7, HHV-8 enable rapid and specific detection prior to clinical symptoms to help improve outcomes – which is especially important for immunosuppressed patients. Testing helps keep track of the effectiveness of active treatment and can monitor for relapse after treatment.

CMV HHV6,7,8 R-gene® : PUBLICATIONS

Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation.
Kotton CN, Kumar D, Caliendo AM, Asberg A, Chou S, Danziger-Isakov L, Humar A; Transplantation Society International CMV Consensus Group.
Transplantation. 2013 Aug 27;96(4):333-60
 

Cytomegalovirus Load in Infl amed Intestinal Tissue Is Predictive of Resistance to Immunosuppressive Therapy in Ulcerative Colitis 
Xavier Roblin, Sylvie Pillet, Abderrahim Oussalah, Philippe Berthelot, Emilie Del Tedesco, Jean-Marc Phellip, Marie-Laure Chambonnière, Olivier Garrau, Laurent Peyrin-Biroulet and Bruno Pozzetto.
Am J Gastroenterol. 2011 Nov;106(11):2001-8

Intérêt de la recherche du cytomegalovirus par polymerase chain reaction dans le syndrôme de Posner-Schlossman.
C.Rodier-Bonifas, P.-L Cornut, G.Billaud, B.Lina, C.Burillon, P.Denis.
Journal Français d'ophtalmologie 2011 34, 24-29

Cytomegalovirus infection in severe burn patients monitoring by real-time polymerase chain reaction : A prospective study 
J.Bordes, J.Maslin, B.Prunet, E.d'Aranda, G.Lacroix, P.Goutorbe, E.Dantzer, E.Meaudre.
Burms (2011), doi:10.1016/j.burns.2010.11.006.

Detection of Cytomegalovirus DNA in EDTA Whole Blood Samples: Evaluation of the Quantitative artus® CMV LC PCR Kit in Conjuntion with Automated Sample Preparation. 
Birgit D.A. Michelin, Ita Hadzisejdic, Michael Bozic, Maja Grahovac, Markus Hess, Blazenka Grahovac, Egon Marth, Harald H. Kessler.
J.Clin. Microbiol., February 2008.
 

Detection of human herpesviruses HHV-6, HHV-7 and HHV-8 in whole blood by real-time PCR using the new CMV, HHV-6, 7, 8 R-gene kit.
Deback C, Agbalika F, Scieux C, Marcelin AG, Gautheret-Dejean A, Cherot J, Hermet L, Roger O, Agut H. 
J Virol Methods. 2008 May;149(2):285-91. Epub 2008 Mar 10.
 

Detection of Human Herpesviruses HHV-6, HHV-7 and HHV-8 in Whole Blood by Real-Time PCR Using the New CMV, HHV-6, 7, 8 R-gene® kit.
Claire Deback, M.D.; Felix Agbalika; Catherine Scieux; Anne-Geneviève Marcelin; Agnès Gautheret-Dejean; Janine Cherot; Laurence Hermet; Odile Roger; Henri Agut. 
J Virol Methods May 2008:149(2):285-91.
 

Evaluation of New Commercial Real-Time PCR Quantification Assay for Prenatal Diagnosis of Cytomegalovirus Congenital Infection.
Aurélie Ducroux, Samira Cherid, Alexandra Benachi, Yves Ville, and Marianne Leruez-Ville.
J of Clinical Microbiology. June 2008,p.2078-2080.
 

Monitoring of human Cytomegalovirus infection in immunosupressed patients using real time PCR on whole blood.
C.Deack, A.M Fillet, N. Dehdin, B. Barrou, S. Vamous, F. Najoullah, F. Bricaire, H. Agut.
J. of Clinical Virology 40 (2007) 173-179.
 

Multicentric evaluation of a new commercial cytomegalovirus real-time PCR quantitation assay.
Gouarin S, Vabret A, Scieux C, Agbalika F, Cherot J, Mengelle C, Deback C, Petitjean J, Dina J, Freymuth F.
J Virol Methods.2007 dec;146(1-2):147-54 

 

Posters :

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, Prague

Comparison of the EZ1 XL advanced and the Magna Pure instruments for the extraction of whole blood before DNA quantification of CMV, EBV, HHV 6 and Adenovirus
Marie Gueudin, Alexandre Louvel, Jean-Christophe Plantier
Laboratoire de virologie, CHU de Rouen, Université de Rouen, France
ECV 2013
 

Validation of the combination of the QIAsymphony extractor with the R-gene kits for the quantification of viral DNA loads: application for cytomegalovirus and Epstein Barr virus DNA monitoring in whole blood specimens
Sylvie Pillet et al
Virology Unit, University Hospital of Saint-Etienne
ECV 2013
 

Validation Of A New EasyMAG Protocol For Extraction Of Viral DNA From Whole Blood: Application To Cytomegalovirus DNA Load Monitoring
Sylvie Pillet et al
Virology Unit, University Hospital of Saint-Etienne
ECV 2013
 

Improvement of NucliSENS® easyMAG® whole blood extraction protocol for virus
Vignoles et al.
CVS 2013
 

CMV R-gene™ real time PCR assay and the candidate 1st WHO International Standard for Human Cytomegalovirus : Standardization of nucleic acid amplification techniques
Vignoles et al.
ESCV 2011

CMV R-gene® real-time  PCR assay and the 1st WHO International standard for CMV: Standardization of PCR techniques
Vignoles M. ; Barranger N. ; Bertrand M. ; Raoux N. ; Magro S. ; Barranger C. ; Joannes M.
Poster 14th annual meeting of th eeuropean society for clinical virology, Madeira, 2011

Evaluation of CMV R-gene PCR (Argene) coupled with EasyMag Biomérieux extraction for CMV viral load quantification in amniotic fluid
Alain et al.
French National reference center for Cytomegaloviruses, CHU Dupuytren, Limoges France
CMV Workshop Nuremberg 2011

Evaluation of CMV R-gene PCR(Argene) coupled with esayMAG® Biomérieux extraction for CMV viral load quantification in amniotic fluid.
Alain S. ; Boyer B. ; Vignoles M. ; Joannes M. ; Barranger C. ; Ploy M-C.
CMV Workshop Nüremberg 2011.
 

Measurement of HSV1, CMV, HHV6 and EBV viral loads in 83 bronchoalveolar lavage (BAL) from lung transplant recipients.
Germi et al.
Unit of Virus Host Cell Interactions, Grenoble
ESCV 2011
 

Human herpesvirus 6 infection after hematopoietic stem cell transplantation : prevalence and risk factor. Jeulin et al.
Laboratory of Virology, Nancy University Hospital, France
CVS 2010
 

Assessment of cytomegalovirus (cmv) load in hematopoietic stem cell transplant recipients by cmv antigenemia and two different real-time pcr assays
Colak et al.
Akdeniz university, School of Medicine, Antalya.
ESCV 2009

Surveillance of cytomegalovirus (cmv) and human herpesvirus-6 (hhv6) infections in pediatric allogeneic stem cell transplant récipients
Mutlu et al.
University School of Medicine Medical Microbiology Department, Antalya, Turkey.
ESCV 2009
 

HHV6 encephalitis in immunocompetent patients, is it a myth ?
Rozé et al.
Département de Microbiologie, Centre Hospitalier Universitaire de Brest
CVS 2009
 

Comparative evaluation of the NucliSENS® easyMAG™ automated system for the extraction of viral DNA from whole blood samples: application to the monitoring of Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) loads
Pillet et al.
Laboratoire de Bacteriologie-Virologie-Hygiène, Hopital Nord, CHU de Saint-Etienne, France.
ECCMID 2008

Performance Evaluation of the Argene Biosoft CMV HHV-6, 7, 8, R-gene Assay
Zhang et al.
North Shore LIJ Health System Laboratories, Lake Success, NY
CVS 2007

 

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