cobas® CMV

Product image for cobas® CMV

Improve patient management and treatment success

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.

Intended use

Intended use

The cobas® CMV is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma. 

The 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.

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

The 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.

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

The cobas® CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. 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. cobas® CMV is not intended for use as a screening test for blood or blood products.

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® 6800/8800 Systems is approved in the EU (CE-IVD) and the United States (US-IVD).

Package inserts

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

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.
  2. COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data.
  3. 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.
  4. 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.
  5. 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.

cobas® CMV for cobas® 4800 System Performance

  • Sample type

    EDTA plasma

  • Sample processing volume

    400 µL

  • Analytical sensitivity

    34.5 lU/mL

  • Linear range

    34.5 - 1.0 x 10IU/mL

  • Specificity

    100%

  • Genotypes detected

    CMV Glycoprotein B Genotype 1-4

  • Drug resistant CMV specimens detected

    CMV specimens resistant against ganciclovir, valganciclovir, cidofovir and foscarnet

cobas® CMV for cobas® 6800/8800 Systems Performance

  • 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