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cobas® EBV

Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> EBV

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 Epstein-Barr Virus (EBV). The test is for use on the automated cobas® 5800/6800/8800 Systems.

Features and benefits of the cobas® EBV test2

  • 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: A 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

Epstein-Barr Virus (EBV) diseases, including EBV-associated post-transplant lymphoproliferative disorder (PTLD) remain important causes of morbidity and mortality in patients undergoing solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT).1 Early detection with best-in-class monitoring tools provides actionable results which enable informed treatment decisions.

cobas® EBV on the 5800/6800/8800 systems performance2

  • 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

Reference

  1. Allen UD, Preiksaitis JK; AST Infectious Diseases Community of Practice. Post-transplant lymphoproliferative disorders, Epstein-Barr virus infection, and disease in solid organ transplantation: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13652. doi: 10.1111/ctr.13652. Epub 2019 Jul 23. PMID: 31230381.
  2. cobas® EBV IFU v3.0, 17 July 2023

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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