Performance of the cobas EBV and cobas BKV assays: multi-site comparison of standardized quantitation.

ABSTRACT: 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

SUBMITTER: Mannonen L 

PROVIDER: S-EPMC11323559 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature