cobas® EBV

For accurate monitoring of Epstein-Barr virus (EBV) in transplant patients

IVD For in vitro diagnostic use.
Setting a new standard for transplant patients

The cobas® EBV test provides reliable, standardized, high-quality results for the improved management of transplant patients at risk of infection. The test is used by healthcare professionals in conjunction with with clinical signs and symptoms and relevant laboratory findings to assess if transplant patients are at risk of developing disease caused by EBV. The test is for use on the automated cobas® 5800/6800/8800 Systems.

Features and benefits of the cobas® EBV test

  • Standardization – Results traceable to the WHO International Standard and reporting in IU/mL for improved harmonization in testing results across hospitals and institutions
  • State-of-the-art design – Best-in-class test design with dual target assay design to provide reliable and reproducible  results for reassurance in clinical decision making
  • Efficiency, flexibility and simplicity – Ability to perform critical transplant testing (CMV, EBV, BKV) from a single sample on the cobas® 5800/6800/8800 Systems with an industry-leading menu, absolute automation and proven performance.

Epstein-Barr virus

EBV could cause transplant-transmitted infections in immunocompromised transplant patients and is associated with a range of cancers, such as post-transplant lymphoproliferative disorder (PTLD).1 Early intervention with best-in-class monitoring tools provides actionable results which enable informed treatment decisions.

Would you like to know more about the cobas® EBV test?

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cobas® EBV on the 5800/6800/8800 Systems Performance

  • Sample type

    EDTA plasma


  • Minimum amount of sample required

    350 µL *


  • Sample processing volume

    200 µL

  • Analytical sensitivity

    18.8 IU/mL (two-sided 95% confidence interval: 14.5 IU/mL – 27.5 IU/mL


  • Linear Range

    35.0 IU/mL to 1E+08 IU/mL

  • Genotypes detected

    Genotypes 1 and 2

  • Overall Precision

    SD 0.02 - 0.17 log10

* Dead volume of 150 μL identified for the cobas® omni Secondary tubes. Other tubes used for testing may have different dead volume and require more or less minimum volume. Contact your local Roche service representative for further info.

Intended Use

Intended Use

cobas® EBV is an in vitro nucleic acid amplification test for the quantification of Epstein-Barr virus (EBV) DNA in human EDTA plasma on the cobas® 5800/6800/8800 Systems.

cobas® EBV is intended for use as an aid in the management of EBV in transplant patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess response to treatment.

The results from cobas® EBV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Negative test results do not preclude EBV infection or EBV disease. Test results must not be the sole basis for patient management decisions. 

cobas® EBV is not intended for use as a screening test for donors of blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps). 

Registration status



  1. Kanakry JA, et al. The clinical significance of EBV DNA in the plasma and peripheral blood mononuclear cells of patients with or without EBV diseases. Blood. 2016; Apr 21;127(16):2007-17


Detailed Specifications

Ordering Information

Compatible Instruments


    Technical Documents

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