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Measurement uncertainty for practical use
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Acibadem Mehmet Ali Aydinlar Univ, Turkey.
Linköping University, Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry and Pharmacology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Chemistry. EFLM Task & Finish Grp Pract Approach Measurement, Italy.ORCID iD: 0000-0003-0756-7723
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Reinier Haga Med Diagnost Ctr, Netherlands.
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Haraldsplass Diaconess Hosp, Norway; Univ Bergen, Norway.
2022 (English)In: Clinica Chimica Acta, ISSN 0009-8981, E-ISSN 1873-3492, Vol. 531, p. 352-360Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
ELSEVIER , 2022. Vol. 531, p. 352-360
Keywords [en]
Keywords; Commutability; Harmonization; Internal quality control; Measurement uncertainty
National Category
Medical Laboratory Technologies
Identifiers
URN: urn:nbn:se:liu:diva-186152DOI: 10.1016/j.cca.2022.04.1003ISI: 000806225200017PubMedID: 35513038OAI: oai:DiVA.org:liu-186152DiVA, id: diva2:1674621
Available from: 2022-06-22 Created: 2022-06-22 Last updated: 2025-02-09

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