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Permanent URI for this collectionhttps://hdl.handle.net/11443/932

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Author: search.filters.author.Chem, European Federation ClinicalSubject: search.filters.subject.analytical performance specification

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    European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants
    (WALTER DE GRUYTER GMBH, 2022-01-01) Bottani, Michela; Aarsand, Aasne K.; Banfi, Giuseppe; Locatelli, Massimo; Coskun, Abdurrahman; Diaz-Garzon, Jorge; Fernandez-Calle, Pilar; Sandberg, Sverre; Ceriotti, Ferruccio; Carobene, Anna; Chem, European Federation Clinical
    Objectives 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
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    The European Biological Variation Study (EuBIVAS): Biological Variation Data for Coagulation Markers Estimated by a Bayesian Model
    (OXFORD UNIV PRESS INC, 2021-01-01) Aarsand, Aasne K.; Kristoffersen, Ann Helen; Sandberg, Sverre; Stove, Bard; Coskun, Abdurrahman; Fernandez-Calle, Pilar; Diaz-Garzon, Jorge; Guerra, Elena; Ceriotti, Ferruccio; Jonker, Niels; Roraas, Thomas; Carobene, Anna; Chem, European Federation Clinical
    BACKGROUND: For biological variation (BV) data to be safely used, data must be reliable and relevant to the population in which they are applied. We used samples from the European Biological Variation Study (EuBIVAS) to determine BV of coagulation markers by a Bayesian model robust to extreme observations and used the derived within-participant BV estimates {[}CVP(i)] to assess the applicability of the BV estimates in clinical practice. METHOD: Plasma samples were drawn from 92 healthy individuals for 10 consecutive weeks at 6 European laboratories and analyzed in duplicate for activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, D-dimer, antithrombin (AT), protein C, protein S free, and factor VIII (FVIII). A Bayesian model with Student t likelihoods for samples and replicates was applied to derive CVP(i) and predicted BV estimates with 95\% credibility intervals. RESULTS: For all markers except D-dimer, CVP( i) were homogeneously distributed in the overall study population or in subgroups. Mean within-subject estimates (CVI) were <5\% for APTT, PT, AT, and protein S free, <10\% for protein C and FVIII, and <12\% for fibrinogen. For APTT, protein C, and protein S free, estimates were significantly lower in men than in women <= 50 years. CONCLUSION: For most coagulation markers, a common CVI estimate for men and women is applicable, whereas for APTT, protein C, and protein S free, sex-specific reference change values should be applied. The use of a Bayesian model to deliver individual CVP(i) allows for improved interpretation and application of the data.
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    Biological variation of serum iron from the European biological variation study (EuBIVAS)
    (WALTER DE GRUYTER GMBH, 2022-01-01) Carobene, Anna; Aarsand, Aasne K.; Coskun, Abdurrahman; Diaz-Garzon, Jorge; Locatelli, Massimo; Fernandez-Calle, Pilar; Sandberg, Sverre; Ceriotti, Ferruccio; Chem, European Federation Clinical