Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: ©Croatian Society of Medical Biochemistry and Laboratory Medicine.
Copyright: 2020, Croatian Society of Medical Biochemistry
License (open-access):
This is an Open Access article distributed under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 21 June 2020
Date accepted: 05 October 2020
Publication date (electronic): 15 December 2020
Publication date (print): 15 February 2021
Volume: 31
Issue: 1
Electronic Location Identifier: 010501
Publisher ID: bm-31-1-010501
DOI: 10.11613/BM.2021.010501
Estimation of the measurement uncertainty and practical suggestion for the description of the metrological traceability in clinical laboratories
Clinicians request a large part of measurements of biological quantities that clinical laboratories perform for diagnostic, prognostic or diseases monitoring purposes. Thus, laboratories need to provide patient’s results as reliable as possible. Metrological concepts like measurement uncertainty and metrological traceability allow to know the accuracy of these results and guarantee their comparability over time and space. Such is the importance of these two parameters that the estimation of measurement uncertainty and the knowledge of metrological traceability is required for clinical laboratories accredited by ISO 15189:2012. Despite there are many publications or guidelines to estimate the measurement uncertainty in clinical laboratories, it is not entirely clear what information and which formulae they should use to calculate it. On the other hand, unfortunately, there are a small number of clinical laboratories that know and describe the metrological traceability of their results, even though they are aware of the lack of comparability that currently exists for patient’s results. Thus, to try to facilitate the task of clinical laboratories, this review aims to provide a proposal to estimate the measurement uncertainty. Also, different suggestions are shown to describe the metrological traceability. Measurement uncertainty estimation is partially based on the ISO/TS 20914:2019 guideline, and the metrological traceability described using the ISO 17511:2020. Different biological quantities routinely measured in clinical laboratories are used to exemplify the proposal and suggestions.
Keywords: biostatistics; quality control; standardization; traceability; uncertainty