Performance of the cobas EBV and cobas BKV assays: multi-site comparison of standardized quantitation.
Autor: | Mannonen L; Department of Clinical Microbiology, HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Jokela P; Department of Clinical Microbiology, HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Kragh Thomsen M; Department of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark., Yerly S; Laboratory of Virology, Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland., Cilla G; Department of Microbiology, Donostia University Hospital and Biodonostia Health Research Institute, San Sebastián, Spain., Jarem D; Clinical Development and Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, California, USA., Canchola JA; CDMA Biometrics, Biostatistics Group, Roche Molecular Systems, Inc., Pleasanton, California, USA., Hopkins M; Department of Virology, Barts Health NHS Trust, London, United Kingdom.; Department of Infection and Immunity, Liverpool University Hospitals NHS Trust, Liverpool, United Kingdom. |
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Jazyk: | angličtina |
Zdroj: | Journal of clinical microbiology [J Clin Microbiol] 2024 Aug 14; Vol. 62 (8), pp. e0026724. Date of Electronic Publication: 2024 Jul 24. |
DOI: | 10.1128/jcm.00267-24 |
Abstrakt: | Guidelines recommend monitoring of Epstein-Barr virus (EBV) and BK virus (BKV) in solid organ and hematopoietic stem cell transplant patients. The majority of quantitative DNA testing for EBV and BKV employs unstandardized individual laboratory-developed testing solutions (LDTs), with implications for accuracy, reproducibility, and comparability between laboratories. The performance of the cobas EBV and cobas BKV assays was assessed across five laboratories, using the World Health Organization International Standards (WHO IS) for EBV and BKV, and the National Institute of Standards and Technology Quantitative Standard for BKV, and results were compared with the LDTs in use at the time. Methods were also compared using locally sourced clinical specimens. Variation was high when laboratories reported EBV or BKV DNA values using LDTs, where quantitative values were observed to differ by up to 1.5 log Competing Interests: L.M., P.J., M.K.T., S.Y., and G.C. declare no potential conflicts of interest. Outside of the submitted work, M.H. declares personal fees from Roche Diagnostics (speaker's honoraria). J.A.C. is an employee of Roche Molecular Systems, Inc. D.J. is an employee of Roche Molecular Systems, Inc. and participates in Roche Connect. |
Databáze: | MEDLINE |
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