Do you need more information
Do you need more information
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.
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.
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) | |
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Principle of the test | Genomic detection and quantification of CMV |
Ordering information | Reference 69-003B: CMV R-GENE® Quantification kit Also available under reference 69-003: CMV R-GENE® Quantification COMPLETE kit (included 69-003B Quantification kit and ref. 67-000 DNA extraction kit) |
Technology | Real-Time PCR / 5‘ nuclease Taqman technology |
Gene target | ppUL83 protein |
Specimen* | Whole blood, plasma, serum, CSF, amniotic fluid, biopsies, Urine, BAL |
Detection limit | LoD 95% : 22 copies/PCR (555 copies/mL) LoD 5% : 1 copie/ml (30 copies/mL) |
Dynamic Range of Quantification | Up to 107 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 | -18°C/-22°C for reference 69-003B (Quantification kit) +2°C/+8°C for ref. 67-000 (DNA extraction kit) |
Validated Extraction platform* Manual Automated | QIAamp DNA Blood Mini kit NucliSENS® easyMAG® MagNA Pure Compact MagNA Pure LC MagNA Pure 96 QIAcube QIAsymphony SP |
m2000sp VERSANT kPCR Molecular System SP | |
Validated Amplification platform* | Life Technologies (Applied Biosystems) LightCycler RotorGene VERSANT kPCR Molecular System AD Biorad DX Real-Time system Stratagene / Agilent |
Status | For in vitro diagnostic use |
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.
Need to calculate your conversion factor to express your CMV R-gene® results in IU/ml? Please download a calculation protocol.
Download Protocol » | Download Excel file » | Download Poster » |
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
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.