COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

Product image for COBAS®AmpliPrep/COBAS®TaqMan®CMV Test

Improve patient management and treatment success

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.5,6The 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

 

Features and benefits

  • Low sample input volume of 650 µL, for serum and 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)

Setting the standard in monitoring CMV infection

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.

Note: The FDA has approved the testing of blood samples for the Zika virus using the cobas®Zika test under a specific protocol by U.S. blood screening laboratories.9 For use on cobas®6800/8800 Systems, the cobas® Zika test under a specific protocol by U.S. blood screening laboratories.

Intended use

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.

 

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is intended for use as an aid in the management of solid-organ transplant and hematopoietic stem-cell transplant patients who are undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test must be interpreted within the context of all relevant clinical and laboratory findings.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.

 

Registration status

CE-IVD, 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. COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data.
  4. Hirsch HH, Lautenschlager I, Pinsky BA, et al. An international multicenter performance analysis of cytomegalovirus load tests. Clin Infect Dis. 2013;56:367-73.
  5. Wolff DJ et al. Multi-site PCR-based CMV viral load assessment-assays demonstrate linearity and precision, but lack numeric standardization. A report of the Association for Molecular Pathology. J Mol Diagn. 2009;11:87–92.
  6. Pang XL, Fox JD, Fenton JM, Miller GG, Caliendo AM, Preiksaitis JK. Interlaboratory comparison of cytomegalovirus viral load assays. Am J Transplant. 2009;9:258–268.
  7. 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.
  8. 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.
  9. Food and Drug Administration (FDA). Recommendations for donor screening, deferral, and product management to reduce the risk of transfusion-transmission of Zika virus. Department of Health and Human Services, Food and Drug Administration; 2016. www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM486360. Accessed January 20, 2017.

Performance

  • Sample type

    EDTA plasma

  • Sample processing volume

    350 µL

  • Analytical sensitivity (CE-IVD)

    56 IU/mL (PROBIT Analysis 95% confidence)

  • Analytical sensitivity (US-IVD)

    56 IU/mL (91 IU/mL (95% Hit Rate)

  • Linear range

    137 – 9.1 x 106 IU/mL

  • Specificity (CE-IVD)

    99.3% specificity rate (95% confidence interval: 96.4%-100.0%)

  • Specificity (US-IVD)

    100% negativity rate with 95% CI: 98.3% to 100%

  • Genotypes detected

    CMV Glycoprotein B Genotype 1-4

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