Measurement uncertainty for practical use.

Autor: Coskun A; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; School of Medicine, Department of Medical Biochemistry, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey. Electronic address: coskun2002@gmail.com., Theodorsson E; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; Division of Clinical Chemistry, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden., Oosterhuis WP; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; Reinier Haga Medisch Diagnostisch Centrum, Delft, the Netherlands., Sandberg S; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; The Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Diaconess Hospital, Norway; Department of Global Health and Primary Health Care, University of Bergen, Norway.
Jazyk: angličtina
Zdroj: Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2022 Jun 01; Vol. 531, pp. 352-360. Date of Electronic Publication: 2022 May 02.
DOI: 10.1016/j.cca.2022.04.1003
Abstrakt: Uncertainty is an inseparable part of all kinds of measurements performed in clinical laboratories. Accreditation standards including the ISO/IEC 17025:2017 and ISO 15189:2012 require that laboratories have routines for calculating the measurement uncertainty of reported results. Various guidelines such as CLSI EP29, Nordest 537, and ISO 20914:2019 have proposed methods for this purpose. However, due to the conceived complexity of the proposed calculation methods, these guidelines have not been generally and effectively applied in clinical laboratories. High workload and measurand heterogeneity favor a pragmatic utilitarian approach. The purpose of this paper is to describe such an approach, including its advantages and disadvantages. Measurement uncertainty should include the most influential factors affecting patients' test results. Since patients' samples for the same measurand can be analyzed in one laboratory or several laboratories using different measuring systems, the measurement uncertainty should be calculated using results obtained from analyzing the same internal quality control material if commutable or patients pooled/split samples.
(Copyright © 2022 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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