Performance specifications for sodium should not be based on biological variation.

Autor: Oosterhuis WP; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; Reinier Haga Medical Diagnostic Center, Delft, The Netherlands. Electronic address: w.oosterhuis@rdgg.nl., 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., Sandberg S; EFLM Task and Finish Group on Practical Approach to Measurement Uncertainty, Milan, Italy; The Norwegian Organisation for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Diaconess Hospital, Norway; Department of Global Health and Primary Health Care, University of Bergen, Norway. Electronic address: sverresandberg@me.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. Electronic address: elvar.theodorsson@gmail.com.
Jazyk: angličtina
Zdroj: Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2023 Feb 01; Vol. 540, pp. 117221. Date of Electronic Publication: 2023 Jan 11.
DOI: 10.1016/j.cca.2023.117221
Abstrakt: When increasing the quality in clinical laboratories by decreasing measurement uncertainty, reliable methods are needed not only to quantify the performance of measuring systems, but also to set goals for the performance. Sigma metrics used in medical laboratories for documenting and expressing levels of performance, are evidently totally dependent on the "total permissible error" used in the formulas. Although the conventional biological variation (BV) based model for calculation of the permissible (or allowable) total error is commonly used, it has been shown to be flawed. Alternative methods are proposed, mainly also based on the within-subject BV. Measurement uncertainty models might offer an alternative to total error models. Defining the limits for analytical quality still poses a challenge in both models. The aim of the present paper is to critically discuss current methods for establishing performance specifications by using the measurement of sodium concentrations in plasma or serum. Sodium can be measured with high accuracy but fails by far to meet conventional performance specifications based on BV. Since the use of sodium concentrations is well established for supporting clinical care, we question the concept that quality criteria for sodium and similar analytes that are under strict homeostatic control are best set by biology.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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