Uncertainty of measurement results in laboratory medicine

Abstract

The issues of reliability of measurement results in laboratory diagnostics, on the basis of which medical decisions are made, are considered. For a correct diagnosis, especially if the measurement results are close to the reference values of the parameters being determined, it is necessary to evaluate the accuracy and/or uncertainty of the measurement results. Therefore, the document ISO/TS 20914:2019 “Medical laboratories – Practical guidance for the estimation of measurement uncertainty” was developed, which follows the GUM methodology, but at the same time sets out a practical approach to estimating uncertainty based on all information available in a laboratory. This article presents an example of estimating measurement uncertainty based on data available in a medical laboratory. Particular attention was paid to the assessment of measurement precision, type A uncertainty. The purpose of the study was to analyze data available for the laboratory and assess the compliance of the obtained measurement results with current requirements. Thanks to the implementation of the ISO/TS 20914:2019 in activities of medical laboratories, it is possible to evaluate the uncertainty of measurement results based on the data available in the laboratory, as well as to evaluate the factors that make maximum contribution to the measurement uncertainty.