The EuBIVAS: Within- and between-subject biological variation data for electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose

Aasne K. Aarsand (Lead / Corresponding author), Jorge Díaz-Garzón, Pilar Fernandez-Calle, Elena Guerra, Massimo Locatelli, William A. Bartlett, Sverre Sandberg, Thomas Røraas, Ferruccio Ceriotti, Una Ørvim Sølvik, Marit Sverresdotter Sylte, Abdurrahman Coşkun, Mustafa Serteser, Ibrahim Unsal, Francesca Tosato, Mario Plebani, Niels Jonker, Gerhard Barla, Anna Carobene

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Abstract

Background: The European Federation of Clinical Chemistry and Laboratory Medicine European Biological Variation Study (EuBIVAS) has been established to deliver rigorously determined data describing biological variation (BV) of clinically important measurands. Here, EuBIVAS-based BV estimates of serum electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose, as well as their associated analytical performance specifications (APSs), are presented.

Method: Samples were drawn from 91 healthy individuals (38 male, 53 female; age range, 21-69 years) for 10 consecutive weeks at 6 European laboratories. Samples were stored at -80 °C before duplicate analysis of all samples on an ADVIA 2400 (Siemens Healthineers). Outlier and homogeneity analyses were performed, followed by CV-ANOVA on trend-corrected data, when relevant, to determine BV estimates with CIs.

Results: The within-subject BV (CVI) estimates of all measurands, except for urea and LDL cholesterol, were lower than estimates available in an online BV database, with differences being most pronounced for HDL cholesterol, glucose, and direct bilirubin. Significant differences in CVI for men and women/women <50 years of age were evident for uric acid, triglycerides, and urea. The CVA obtained for sodium and magnesium exceeded the EuBIVAS-based APS for imprecision.

Conclusions: The EuBIVAS, which is fully compliant with the recently published Biological Variation Data Critical Appraisal Checklist, has produced well-characterized, high-quality BV estimates utilizing a stringent experimental protocol. These new reference data deliver revised and more exacting APS and reference change values for commonly used clinically important measurands, thus having direct relevance to diagnostics manufacturers, service providers, clinical users, and ultimately patients.

Original languageEnglish
Pages (from-to)1380-1393
Number of pages14
JournalClinical Chemistry
Volume64
Issue number9
Early online date28 Aug 2018
DOIs
Publication statusPublished - Sep 2018

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    Aarsand, A. K., Díaz-Garzón, J., Fernandez-Calle, P., Guerra, E., Locatelli, M., Bartlett, W. A., Sandberg, S., Røraas, T., Ceriotti, F., Sølvik, U. Ø., Sylte, M. S., Coşkun, A., Serteser, M., Unsal, I., Tosato, F., Plebani, M., Jonker, N., Barla, G., & Carobene, A. (2018). The EuBIVAS: Within- and between-subject biological variation data for electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose. Clinical Chemistry, 64(9), 1380-1393. https://doi.org/10.1373/clinchem.2018.288415