Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
Cytomegalovirus (CMV) is a leading cause of morbidity and mortality in both hematopoietic stem cell and solid organ transplant recipients.. Severe CMV infection in high-risk patients may develop soon after transplantation and, without effective treatment, may lead to CMV syndrome (i.e. fever, malaise, leukopenia, etc), tissue tissue invasive "end-organ" disease, and potential rejection or loss of the graft.
The cobas® CMV test 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.
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.
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.
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 is validated with ready-to-use reagents, performed on a fully automated platform solutions that include calibration.3
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.4,5 With the standardized, CE-IVD real-time cobas®CMV PCR viral load test to spot CMV, we can collectively help transplant patients thrive.
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