cobas® BKV

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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 EDTA plasma sample on the cobas® 6800/8800 Systems with an industry-leading menu, for proven performance and allowing for absolute automation
  • Enabling BKV Urine testing the right way  Urine sample stabilized in cobas® PCR Media allows to maintain the integrity of results, enable faster preparation, without the need of refrigeration, making storage and transportation more convenient
 
 

BK polyomavirus

 

BKV could cause transplant-transmitted infections in immunocompromised transplant patients and is linked to post-transplant complications, such as nephropathy in kidney transplants and hemorrhagic cystitis in hematopoietic stem cell transplants.1,2  Early intervention with best-in-class monitoring tools provides actionable results which enable informed treatment decisions.

Intended use

cobas® BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in cobas® PCR Media. 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 in EDTA plasma, 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
  2. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Preface. Bone Marrow Transplant. 2009;44:453-5. doi: 10.1038/bmt.2009.254. PubMed PMID: 19861977.

*Not available in the United States.

cobas® BKV performance summary

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cobas® BKV performance summary

PARAMETER PERFORMANCE
Assay targets VP2 | small t-Antigen
Sample type
EDTA Plasma Urine stabilized in cobas PCR media
Minimum amount of sample required 350 µL 550 µL
Sample processing volume 200 µL 400 µL
Analytical sensitivity 21.5 IU/mL (95% CI 16.3 IU/mL - 32.4 IU/mL)  12.2 IU/mL (95% CI 9.2 IU/mL - 18.3 IU/mL)
Linear range 21.5 IU/mL to 1E+08 IU/mL 200 IU/mL to 1E+08 IU/mL
specificity 100% 100%
Overall Precision SD 0.03 - 0.11 log10 SD 0.02 - 0.05 log10
Subtypes detected Subtypes I (Ia, Ib and Ic), II, III and IV