COBAS® AmpliPrep/COBAS® TaqMan® CMV Test 

 
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Canada-IVD
CE-IVD
US-IVD

 

Setting the standard in assessing virological response in CMV infection

Improve disease management and patient care with a Roche real-time, fully automated PCR test

Cytomegalovirus 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.
 
Roche’s  CMV Test reliably monitors Cytomegalovirus (CMV) infection in patients receiving antiviral therapy.

Features and Benefits

 

With the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test, you can be reassured that you are receiving:

  • Fulfill international guideline recommendations

    Demonstrating co-linearity to the WHO international standard and reports results in IU/mL, as recommended by the international consensus guidelines for CMV management in solid organ transplant patients*†
  • Proven advantages with a clinically validated test over lab developed tests (LDT)

    Complexity in running an LDT includes ‘in-house’ validations; manual quality control and quality assurance of reagents; ongoing verification studies and proficiency testing. The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test has been used in key clinical studies, demonstrating clinical utility of CMV viral load monitoring‡§
  • A test that provides reproducible and reliable results for reassurance in clinical decision making

    Proven to provide reliable, comparable and reproducible viral load results across different institutions, over several orders of magnitude. The first standardized CMV viral load test with CE and FDA approval.†

Intended Use

 

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus DNA in human plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test can quantitate CMV DNA over the range of 150 - 10,000,000 copies/mL. One copy of CMV DNA (as defined by the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test) is equivalent to 0.91 International Unit (IU) on the First WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162).

 

The test is intended to be used in conjunction with clinical presentation and other laboratory markers in the diagnosis and management of CMV infection in patients at risk for CMV disease.

 

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV in blood or blood products or as a diagnostic test to confirm the presence of CMV infection. The results from the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test must be interpreted within the context of all relevant clinical and laboratory findings.







*Kotton, C. N., Kumar, D., Caliendo, A. M., Asberg, A., Chou, S. et al. (2013). Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation 96, 333-360.

†COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data

‡Razonable RR, Åsberg A, Rollag H, Duncan J, Boisvert D, Yao JD, Caliendo AM, Humar A, Do TD. 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., Jardine, A. G., Mouas, H., Pescovitz, M. D., Sgarabotto, D., Tuncer, M., Noronha, I. L., Hartmann, A. and on behalf of the VICTOR Study Group (2007), Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients. Am J of Transplant, 7: 2106–2113
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