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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.
Setting a new standard for transplant patients
BK Polyomavirus (BKPyV) is a significant pathogen in transplant recipients, where viral reactivation can lead to serious complications such as polyomavirus-associated nephropathy (PVAN) and hemorrhagic cystitis, posing a direct threat to allograft survival and patient health.1,2 Early detection with best-in-class monitoring tools provides actionable results, enabling informed treatment decisions.
The cobas® BKV test provides reliable, standardized, high-quality results for the improved management of transplant patients at risk of infection. The BKV test is intended for use as an aid in the management of BKV in kidney and hematopoietic stem cell transplant patients, with results used to indicate the need for potential treatment changes.3 The test is for use on the automated cobas® 5800/6800/8800 systems.
cobas BKV test for cobas 5800/6800/8800 systems performance3
View full tablecobas BKV test for cobas 5800/6800/8800 systems performance3
Product specification |
Value |
Dual assay targets |
VP2 and small t-Antigen |
Sample types |
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 |
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Overview
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References
- 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;33(9):e13528.
- Tomblyn M, et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Preface. Bone Marrow Transplant. 2009;44:453-5.
- F. Hoffmann-La Roche Ltd. cobas® BKV quantitative nucleic acid test for use on cobas® 5800/6800/8800 systems (Package insert 09478124001-04EN).