cobas® BKV

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

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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 transplant patients are at risk of developing disease caused by BKV, 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 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 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

 

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.

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

  • 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

Intended use

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 on the cobas® 6800/8800 Systems.

cobas® BKV is intended for use as an aid in the 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. 

In urine stabilized in cobas® PCR Media, cobas® BKV is intended for use as an aid in the management of BKV in transplant patients.

The results from cobas® BKV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.

cobas® BKV is not intended for use as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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. 

In 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.

The results from cobas® BKV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.

cobas® BKV is not intended for use as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Registration status

CE-IVD and US-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.