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cobas® CMV

Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems
IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> CMV

Enhancing the picture of CMV control

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.

 

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 is validated with ready-to-use reagents, performed on a fully automated platform solutions that include calibration.3

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.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.

cobas® CMV for cobas® 5800/6800/8800 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

  • Drug resistant CMV specimens detected

    CMV specimens resistant against ganciclovir, valganciclovir, cidofovir and foscarnet

References

  1.  Kotton, Camille N. MD1; Kumar, Deepali MD2; Caliendo, Angela M. MD, PhD3; Huprikar, Shirish MD4; Chou, Sunwen MD5; Danziger-Isakov, Lara MD, MPH6; Humar, Atul MD7 on behalf of the The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation 102(6):p 900-931, June 2018.
  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. Health Organization International Standard for Human Cytomegalovirus.J Clin Microbiol. 2015;53:3325–3333.
  5. Additional reference: Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13512.

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