COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test

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.¹

The COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test reliably monitors Cytomegalovirus infection and is proven to provide comparable and reproducible viral load results across different institutions, over several orders of magnitude. It is the first standardized CMV viral load test with CE and FDA approval.²

You can realize the following benefits for your laboratory and clinicians:

Standardization

The COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test 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.^1,3 It helps bring standardization to sample type (plasma) for testing and delivers results that align across institutions to optimize CMV management.

Clinical Validation

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 the COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test, including clinical trials required to demonstrate clinical utility. The COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test is referenced in the International Consensus Guidelines for the Management of CMV in SOT patients (2013) through a multi-center study conducted by Hirsch, et al.⁴

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.^5,6 The COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test is validated with ready-to-use reagents, performed on a fully automated platform solution, and includes calibration.^7,8

• Low sample input volume of 650 µL, for plasma
• Flexible batch size with continuous loading feature and interleave capability with core virology COBAS^® TaqMan^® assays (HIV-1, HBV, HCV Quant and HCV Qual and CMV)
• Fulfill international guideline recommendations for reporting in IU/mL
• Ensuring labs deliver test results that align across institutions with WHO standardization
• Clinically validated test used in developing new drugs and references in current international guidelines for solid organ transplant patients
• Minimize variability in testing results and complexity in testing versus laboratory developed tests (LDTs)

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. The COBAS^® AmpliPrep/COBAS^® TaqMan^® CMV Test offers traceability to the international WHO Standard.

CE-IVD, US IVD

Access package inserts through your country’s Roche Diagnostics Website.