cobas® CMV
Enhancing the picture of CMV control
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.
The cobas® CMV reliably monitors CMV infection and is proven to provide comparable and reproducible viral load results across different institutions to reliably spot CMV and help transplant patients thrive. You can realise the following benefits for your laboratory and clinicians.
Standardization
The 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 standardisation to sample type (plasma) for testing and delivers results that align across institutions to optimise CMV management.
Clinical Validation
The 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. The cobas® CMV (CE-IVD) is validated with ready-to-use reagents, performed on a fully automated platform solutions that include 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
Setting the standard in monitoring CMV infection
Unite against CMV with the assurance your clinicians need in clinical decision-making without the need to manage the complexity of lab developed tests. Progress towards standardization has been made, but there is still opportunity for improvement.5 With the standardized, CE-IVD real-time cobas®CMV PCR viral load test to spot CMV, we can collectively help transplant patients thrive.
Registration status
cobas® CMV for use on the cobas® 4800 System is approved in the EU (CE-IVD). It is not approved in the United States.
cobas® CMV for use on the cobas® 5800/6800/8800 Systems is approved in the EU (CE-IVD).
cobas® CMV for use on the cobas® 5800/6800/8800 Systems is approved in the United States (US-IVD).
Package inserts
Access package inserts through your country’s Roche Diagnostics Website.
References
- 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.
- COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data.
- 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.
- 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.
- Hayden RT, Preiksaitis J, Tong Y, et al. Commutability of the First World Health Organization International Standard for Human Cytomegalovirus.J Clin Microbiol. 2015;53:3325–3333.