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cobas® BKV

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

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

Setting a new standard for transplant patients

The cobas® BKV test provides reliable, standardized, high-quality results for the improved management of transplant patients at risk of infection. Healthcare professionals use this test to assess if kidney and hematopoietic stem cell transplant patients are at risk of developing disease caused by BK virus, which can contribute to graft loss or organ rejection. The test is for use on the automated cobas® 5800/6800/8800 Systems.

Features and benefits of the cobas® BKV test3

  • 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
  • Enabling BKV urine testing the right way: Urine sample stabilized in cobas® PCR media allows result integrity to be maintained, enabling faster preparation and making storage and transportation more convenient without the need of refrigeration

BK polyomavirus

BK virus 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.

cobas® BKV for cobas® 5800/6800/8800 Systems Performance3

  • Assay targets

    VP2 | small t-Antigen

  • Sample type

    EDTA Plasma
    Urine stabilized in cobas® PCR media

  • Minimum amount of sample required

    EDTA Plasma: 350 µL
    Urine: 550 µL

  • Sample processing volume

    EDTA Plasma: 200 µL
    Urine: 400 µL

  • Analytical sensitivity

    EDTA Plasma: 21.5 IU/mL (95% CI 16.3 IU/mL - 32.4 IU/mL)
    Urine: 12.2 IU/mL (95% CI 9.2 IU/mL - 18.3 IU/mL)

  • Linear range

    EDTA Plasma: 21.5 IU/mL to 1E+08 IU/mL
    Urine: 200 IU/mL to 1E+08 IU/mL

  • Overall precision

    EDTA Plasma: SD 0.03 - 0.13 log10
    Urine: SD 0.02 - 0.07 log10

  • Subtypes detected

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

References

  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.
  3. cobas® BKV IFU v3.0 , 3 Aug 2023

Overview

Detailed Specifications

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