cobas® BKV

Product Image for cobas BKV

For accurate monitoring of BK polyomavirus (BKV) infection in transplant patients

Setting a new standard for transplant patients

 

The cobas® BKV test provides reliable, standardized, high-quality results for clinical decision-making and for the improved management of transplant patients at risk of infection. Healthcare professionals use this test to assess if transplant patients are at risk of developing disease caused by BKV, which can contribute to organ rejection.  The test is for use on the automated cobas® 6800/8800 Systems in countries accepting the CE mark.

 

Features and benefits of the cobas® BKV 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 designs 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, for proven performance and allowing for absolute automation
 
 

BK polyomavirus

 

BKV could cause transplant-transmitted infections in immunocompromised transplant patients and is linked to post-transplant complications, such as nephropathy in kidney transplantation.1 Early intervention with best-in-class monitoring tools provides actionable results which enable informed treatment decisions.

Intended use

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

 

Registration status

CE-IVD

Reference

  1. Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Mar 12

cobas® BKV on the 6800/8800 Systems* Performance

  • Sample type

    EDTA plasma

  • Minimum amount of sample required

    350 µL

  • Sample processing volume

    200 µL

  • Analytical sensitivity

    21.5 IU/mL

  • Linear Range

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

  • Specificity

    100%

  • Subtypes detected

    Subtypes I (Ia and Ic), II, III and IV

  • Overall Precision

    SD 0.03 - 0.11 log10

*Not available in the United States.