European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants

dc.contributor.authorBottani, Michela
dc.contributor.authorAarsand, Aasne K.
dc.contributor.authorBanfi, Giuseppe
dc.contributor.authorLocatelli, Massimo
dc.contributor.authorCoskun, Abdurrahman
dc.contributor.authorDiaz-Garzon, Jorge
dc.contributor.authorFernandez-Calle, Pilar
dc.contributor.authorSandberg, Sverre
dc.contributor.authorCeriotti, Ferruccio
dc.contributor.authorCarobene, Anna
dc.contributor.authorChem, European Federation Clinical
dc.date.accessioned2023-02-21T12:40:39Z
dc.date.available2023-02-21T12:40:39Z
dc.date.issued2022-01-01
dc.description.abstractObjectives Thyroid biomarkers are fundamental for the diagnosis of thyroid disorders and for the monitoring and treatment of patients with these diseases. The knowledge of biological variation (BV) is important to define analytical performance specifications (APS) and reference change values (RCV). The aim of this study was to deliver BV estimates for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), thyroglobulin (TG), and calcitonin (CT). Methods Analyses were performed on serum samples obtained from the European Biological Variation Study population (91 healthy individuals from six European laboratories
dc.description.abstract21-69 years) on the Roche Cobas e801 at the San Raffaele Hospital (Milan, Italy). All samples from each individual were evaluated in duplicate within a single run. The BV estimates with 95\% CIs were obtained by CV-ANOVA, after analysis of variance homogeneity and outliers. Results The within-subject (CVI) BV estimates were for TSH 17.7\%, FT3 5.0\%, FT4 4.8\%, TG 10.3, and CT 13.0\%, all significantly lower than those reported in the literature. No significant differences were observed for BV estimates between men and women. Conclusions The availability of updated, in the case of CT not previously published, BV estimates for thyroid markers based on the large scale EuBIVAS study allows for refined APS and associated RCV applicable in the diagnosis and management of thyroid and related diseases.
dc.description.issue4
dc.description.issueMAR 28
dc.description.pages523-532
dc.description.volume60
dc.identifier.doi10.1515/cclm-2020-1885
dc.identifier.urihttps://hdl.handle.net/11443/2637
dc.identifier.urihttp://dx.doi.org/10.1515/cclm-2020-1885
dc.identifier.wosWOS:000737398400001
dc.publisherWALTER DE GRUYTER GMBH
dc.relation.ispartofCLINICAL CHEMISTRY AND LABORATORY MEDICINE
dc.subjectanalytical performance specification
dc.subjectbiological variation
dc.subjectreference change value
dc.subjectthyroid
dc.titleEuropean Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants
dc.typeArticle

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