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Performance specifications for sodium should not be based on biological variation
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Reinier Haga Med Diagnost Ctr, Netherlands; Reinier Graafweg 7, Netherlands.
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Istanbul Univ, Turkey.
EFLM Task & Finish Grp Pract Approach Measurement, Italy; Haraldsplass Diaconess Hosp, Norway; Univ Bergen, Norway.
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
2023 (English)In: Clinica Chimica Acta, ISSN 0009-8981, E-ISSN 1873-3492, Vol. 540, article id 117221Article in journal (Refereed) Published
Abstract [en]

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 specifica-tions 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.

Place, publisher, year, edition, pages
ELSEVIER , 2023. Vol. 540, article id 117221
Keywords [en]
Biological variation; Number of distinct categories; Six Sigma; Sigma metric; Total error; Analytical performance specification
National Category
Medical Laboratory and Measurements Technologies
Identifiers
URN: urn:nbn:se:liu:diva-193601DOI: 10.1016/j.cca.2023.117221ISI: 000974326000001PubMedID: 36640931OAI: oai:DiVA.org:liu-193601DiVA, id: diva2:1755985
Available from: 2023-05-10 Created: 2023-05-10 Last updated: 2023-05-10

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