cobas® EBV

Product image for COBAS®  EBV

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

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 to assess if transplant patients are at risk of developing disease caused by EBV.  The test is for use on the automated cobas® 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 performance 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® 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.

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® 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. 

cobas® EBV is an in vitro nucleic acid amplification test for the quantification of Epstein-Barr virus (EBV) DNA in human EDTA plasma. cobas® EBV is intended for use as an aid in the diagnosis and 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.

Registration status

CE-IVD and de novo (class II)

Reference

  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

cobas® EBV on the 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

  • 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