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CMV R-GENE^®

Real-time PCR kit for the detection and quantification of Cytomegalovirus (CMV) DNA

Accurate quantification of CMV viral load over a wide linear range*
Ready-to-use kit including internal control and quantification standards
CE-IVD on all major extraction platforms and real-time PCR systems and on different sample types

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CMV R-GENE^® advantages

Cytomegalovirus (CMV) is a serious complication for immunocompromised patients. That’s why you want optimized detection and monitoring of CMV infection. CMV-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 – using the broad R-GENE^® range lets you qualify and/or quantify various viruses in one sample or analyze various samples for one virus at the same time.

Sensitive and reproducible
- Reliable measurement of CMV infection
- Wide linear range

Standardized
- Parallel processing with R-GENE^® range of products (EBV R-GENE^®, HSV1 HSV2 VZV R-GENE^®, CMV HHV6,7,8 R-GENE^®, BK Virus R-GENE^®, Adenovirus R-GENE^®, Parvovirus B19 R-GENE^®)
- Harmonized test profiles for multiple assays in one run
- Protocol to convert quantification blood sample results into IU/mL with the WHO 1st International Standard

Flexible
- Validated for use with various samples types
  - Use manual or automated sample preparation such as NucliSENS^® easyMAG^® and assay setup platform such as easySTREAM^™ liquid handling system
- Qualified with the major real-time PCR platforms

Everything you need in one kit

The CMV R-GENE^® kit is a ready-to-use molecular detection kit. It detects and measures the CMV genome using real-time PCR after viral DNA extraction. It works by amplifying and simultaneously detecting a specific region of the CMV genome using 5’ nuclease Taqman technology.

Four Quantification Standards ensure accurate CMV viral load measurement
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 necessary reagents optimized to detect and quantify CMV for in vitro diagnostic use

Easy procedure

Using the CMV R-GENE^®kit is simple. Just add the sample extracted DNA 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”.

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CMV R-GENE^® (69-003B)
Principle of the test	Genomic detection and quantification of CMV
Ordering information	Reference 69-003B - CMV R-GENE® - Real-Time Detection and Quantification kit
Technology	Real-Time PCR / 5‘ nuclease Taqman technology
Gene target	ppUL83 protein
Specimen	Whole blood, Plasma, CSF, Amniotic Fluid, Urine, BAL
Detection limit	446 copies/mL
Dynamic Range of Quantification	From 500 to to 10^7 copies/mL
Controls included	Extraction + Inhibition control, Sensitivity control, Negative control
Results within	75 minutes (extraction step not included)
Reporting unit	Copies/mL or convert to IU/mL with WHO 1st International Standard
Number of tests	90 tests
Storage conditions	-15°C/-31°C
Validated Extraction platform	EMAG^® NUCLISENS^® easyMAG^® MagNA Pure Compact MagNA Pure LC MagNA Pure 96 QIAsymphony SP
Validated Amplification platform	ABI 7500 Fast, ABI 7500 Fast Dx LightCycler 480 (System II) Rotor-Gene Q CFX96
Status	For in vitro diagnostic use

Fast facts on CMV

What is CMV?

The human cytomegalovirus (HCMV) is a double-stranded enveloped DNA virus of the Herpesviridae family. After primary infection, which often occurs in young childhood, HCMV remains in its latent state in the host. While healthy people with CMV are usually asymptomatic, HCMV may cause recurrent secondary infections, during chronic or transient immunosuppression.

Who is most at risk?

HCMV infection is the most common post-transplant infectious agent after organ transplant or bone marrow allograft. Prolonged fever may be the only clinical manifestation. However, it may comprise a number of complications including interstitial pneumonitis, a major complication that occurs in about 20% of all graft recipients and has a 90% mortality rate without treatment. Infection with HCMV aggravates the immunosuppression, favours superinfections and is a factor that triggers or accelerates rejection or GVH (reaction of the graft against the host).

While the incidence of infections with HCMV during HIV/AIDS has decreased by 80% since the use of highly active anti-retroviral treatments, testing is still important to ensure control of CMV and help prevent related opportunistic infections. Clinical manifestations for HIV/AIDS patients, most commonly retinitis and peptic ulcers, occur when immunosuppression is high (CD4+ T lymphocytes under 50/mm3).

During pregnancy, the advent of a maternal primary infection gives rise to complications in 50% of the cases of foetal infection, with this being severe in approximately 10% of cases, with neurological impairment occurring in particular.

What are the benefits of CMV testing?

Real-Time PCR-based assays for CMV enable rapid and specific detection prior to clinical symptoms to help improve outcomes, especially important for organ transplant/bone marrow allograft and HIV/AIDS patients. Testing helps keep track of the effectiveness of active treatment and can monitor for relapse after treatment.

CMV R-GENE^® and the 1st WHO International Standard for Human Cytomegalovirus

Need to calculate your conversion factor to express your CMV R-GENE^® results in IU/ml? Please download a calculation protocol.

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Download Protocol » [3]	Download Excel file » [4]	Download Poster » [5]

Should you wish to order this CMV WHO International Standard (code 09-162). please contact NIBSC at the following link :
http://www.nibsc.org/products/biological_reference_materials/product_catalogue/detail_page.aspx?catid=09/162 [6]

Note: The conversion factors given in the poster are only illustrative for the mentioned combinations. bioMérieux strongly advises to determine the conversion factor in your laboratory.

CMV R-GENE^®: PUBLICATIONS

Cytomegalovirus load in inflamed intestinal tissue is predictive of resistance to immunosuppressive therapy in ulcerative colitis. [7]
Roblin X, Pillet S, Oussalah A, Berthelot P, Del Tedesco E, Phelip JM, Chambonnière ML, Garraud O, Peyrin-Biroulet L, Pozzetto B. Am J Gastroenterol. 2011 Nov;106(11):2001-8. Epub 2011 Jul 26.
Cytomegalovirus infection in severe burn patients monitoring by real-time polymerase chain reaction: A prospective study [8]
Bordes et al. Burns. 2011 May;37(3):434-9. Epub 2011 Jan 14.
Interêt de la recherche du cytomegalovirus par polymerase chain reaction dans le syndrome de Posner-Schlossman [9]
Rodier-Bonifas et al. Journal français d'ophtalmologie, 2011 ; 34, 24-29
Evaluation of new commercial real-time PCR quantification assay for prenatal diagnosis of cytomegalovirus congenital infection. [10]
Ducroux A, Cherid S, Benachi A, Ville Y, Leruez-Ville M.J Clin Microbiol. 2008 Jun;46(6):2078-80. Epub 2008 Apr 16.
Multicentric evaluation of a new commercial cytomegalovirus (CMV) real-time PCR quantification assay [11]
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. Epub 2007 Jul 27.
Detection of cytomegalovirus (CMV) DNA in EDTA whole-blood samples: evaluation of the quantitative artus CMV LightCycler PCR kit in conjunction with automated sample preparation. [12]
Michelin BD, Hadzisejdic I, Bozic M, Grahovac M, Hess M, Grahovac B, Marth E, Kessler HH. J Clin Microbiol. 2008 Apr;46(4):1241-5. Epub 2008 Feb 13.

Please consult your local bioMérieux representative for product availability in your country

COMPLETE YOUR SOLUTION

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CMV R-GENE®

Real-time PCR kit for the detection and quantification of Cytomegalovirus (CMV) DNA

CMV R-GENE® advantages

Everything you need in one kit

Easy procedure

Fast facts on CMV

CMV R-GENE® and the 1st WHO International Standard for Human Cytomegalovirus

CMV R-GENE®: PUBLICATIONS

COMPLETE YOUR SOLUTION

NUCLISENS® easyMAG® [13]

ARGENE® [14]

HHV6 R-GENE® [15]

EBV R-GENE® [16]

HSV1, HSV2, VZV R-GENE® [17]

BK Virus R-GENE® [18]

ADENOVIRUS R-GENE® [19]

Parvovirus B19 R-GENE® [20]

CMV R-GENE® [21]

CMV R-GENE^®

CMV R-GENE^® advantages

CMV R-GENE^® and the 1st WHO International Standard for Human Cytomegalovirus

CMV R-GENE^®: PUBLICATIONS

NUCLISENS^® easyMAG^® [13]

ARGENE^® [14]

HHV6 R-GENE^® [15]

EBV R-GENE^® [16]

HSV1, HSV2, VZV R-GENE^® [17]

BK Virus R-GENE^® [18]

ADENOVIRUS R-GENE^® [19]

Parvovirus B19 R-GENE^® [20]

CMV R-GENE^® [21]