Affiliation:
1. Department of Clinical Biochemistry, North West London Pathology, Imperial College Healthcare NHS Trust, Charing Cross Hospital , London , UK
Abstract
Abstract
Objectives
According to international standards, clinical laboratories are required to verify the performance of assays prior to their implementation in routine practice. This typically involves the assessment of the assay’s imprecision and trueness vs. appropriate targets. The analysis of these data is typically performed using frequentist statistical methods and often requires the use of closed source, proprietary software. The motivation for this paper was therefore to develop an open-source, freely available software capable of performing Bayesian analysis of verification data.
Methods
The veRification application presented here was developed with the freely available R statistical computing environment, using the Shiny application framework. The codebase is fully open-source and is available as an R package on GitHub.
Results
The developed application allows the user to analyze imprecision, trueness against external quality assurance, trueness against reference material, method comparison, and diagnostic performance data within a fully Bayesian framework (with frequentist methods also being available for some analyses).
Conclusions
Bayesian methods can have a steep learning curve and thus the work presented here aims to make Bayesian analyses of clinical laboratory data more accessible. Moreover, the development of the application and seeks to encourage the dissemination of open-source software within the community and provides a framework through which Shiny applications can be developed, shared, and iterated upon.
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Reference38 articles.
1. Khatami, Z, Hill, R, Sturgeon, C, Kearney, E, Breadon, P, Kallner, A. Measurement verification in the clinical laboratory: a guide to assessing analytical performance during the acceptance testing of methods (quantitative examination procedures) and/or analysers. Available from: https://www.acb.org.uk/asset/34B3F3F5%2DAF91%2D4B44%2DAF184C565EDC162B/ [Accessed 19 Jan 2023].
2. Theodorsson, E. Validation and verification of measurement methods in clinical chemistry. Bioanalytical 2012;4:305–20. https://doi.org/10.4155/bio.11.311.
3. Pum, J. A practical guide to validation and verification of analytical methods in the clinical laboratory. Adv Clin Chem 2019;90:215–81. https://doi.org/10.1016/bs.acc.2019.01.006.
4. Colling, LJ, Szűcz, D. Statistical inference and the replication crisis. Rev Philos Psychol 2021;12:121–47. https://doi.org/10.1007/s13164-018-0421-4.
5. van de Schoot, R, Depaoli, S, King, R, Kramer, B, Martens, K, Tadesse, MG, et al.. Bayesian statistics and modelling. Nat Rev Methods Primers 2021;1. https://doi.org/10.1038/s43586-020-00001-2.