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cobas® CMV for the cobas® 6800/8800 Systems

Improve patient management and treatment success

Reliably monitor Cytomegalovirus infection

Cytomegalovirus (CMV) is a leading cause of morbidity and mortality in transplant recipients.  Severe CMV infection in high-risk patients may develop soon after transplantation and, without effective treatment, may lead to CMV syndrome, tissue invasive disease, and potential rejection or loss of the graft.

cobas® CMV reliably monitors CMV infection and is proven to provide comparable and reproducible viral load results across different institutions, over several orders of magnitude. You can realize the following benefits for your laboratory and clinicians:

  • Standardization

cobas® CMV demonstrates co-linearity to the WHO international standard, reporting results in IU/mL as recommended by the international consensus guidelines for CMV management in solid organ transplant patients.1,2 It helps bring standardization to sample type (plasma) for testing and delivers results that align across institutions to optimize CMV management.

  • Clinical Validation

cobas® CMV offers the proven advantages of a clinically validated test. Roche CMV tests have been central in clinical studies for current treatment regimens and those in development. Extensive studies were conducted in the development of cobas® CMV, including clinical trials required to demonstrate clinical utility for FDA submission.

  • Automation

The generation and maintenance of an LDT takes time and effort on the part of the laboratory, and places the burden and associated risk for quality compliance and troubleshooting on the laboratory. cobas® CMV (CE-IVD) is validated with ready-to-use reagents, performed on a fully automated platform solution, and includes calibration.3,4

Features and benefits

  • Co-linearity to the WHO international standard and reports in IU/mL
  • Tight precision at medically relevant decision points
  • Confidence in your results with primers and probes targeting highly conserved regions not impacted by drug resistance mutations

Intended use

CE-IVD

cobas® CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus DNA in human EDTA plasma.

cobas® CMV is intended for use as an aid in the diagnosis and management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. The test can be used in these populations to assess the need to initiate antiviral treatment. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment.

The results from cobas® CMV must be interpreted within the context of all relevant clinical and laboratory findings.

Performance

Parameters Performances
Sample type EDTA plasma
Sample processing volume 350 µL
Analytical sensitivity 34.5 IU/mL
Linear range 34.5 – 1.0 x 107 IU/mL
Specificity 100%
Genotypes detected CMV Glycoprotein B Genotype 1-4

Setting the standard in monitoring CMV infection

Enhance the picture of CMV control with the assurance your clinicians need in clinical decision-making without the need to manage the complexity of lab developed tests. cobas® CMV offers traceability to the international WHO Standard.

References:

  1. Kotton CN, Kumar D, Caliendo AM, et al. Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation. 2013:96;333–360.
  1. COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data.
  1. Razonable RR, Åsberg A, Rollag H, et al. Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the world health organization international standard is predictive of CMV disease resolution in transplant recipients. Clin Infect Dis. 2013;56:1546–1553.
  1. Åsberg A, Humar A, Rollag H, et al. Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients. Am J of Transplant, 2007;7:2106–2113