The European Biological Variation Study (EuBIVAS): A summary report
| Autor: | Ferruccio Ceriotti, Mario Plebani, Niels Jonker, Aasne K. Aarsand, William A. Bartlett, Pilar Fernandez-Calle, Anna Carobene, Massimo Locatelli, Sverre Sandberg, Elena Guerra, Abdurrahman Coskun, Jorge Díaz-Garzón |
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| Přispěvatelé: | Acibadem University Dspace |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Male Research Report 030213 general clinical medicine medicine.medical_specialty Clinical Biochemistry Medical laboratory 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Biological variation Internal medicine reference change values medicine Humans Multicenter Studies as Topic analytical performance specification Soluble transferrin receptor biological variation biology Plasma samples EuBIVAS business.industry Biochemistry (medical) Bayes Theorem General Medicine Prostate-Specific Antigen Healthy individuals Chemistry Clinical Creatinine biology.protein business |
| Zdroj: | Clinical Chemistry and Laboratory Medicine |
| Popis: | Biological variation (BV) data have many important applications in laboratory medicine. Concerns about quality of published BV data led the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 1st Strategic Conference to indicate need for new studies to generate BV estimates of required quality. In response, the EFLM Working Group on BV delivered the multicenter European Biological Variation Study (EuBIVAS). This review summarises the EuBIVAS and its outcomes. Serum/plasma samples were taken from 91 ostensibly healthy individuals for 10 consecutive weeks at 6 European centres. Analysis was performed by Siemens ADVIA 2400 (clinical chemistry), Cobas Roche 8000, c702 and e801 (proteins and tumor markers/hormones respectively), ACL Top 750 (coagulation parameters), and IDS iSYS or DiaSorin Liaison (bone biomarkers). A strict preanalytical and analytical protocol was applied. To determine BV estimates with 95% CI, CV-ANOVA after analysis of outliers, homogeneity and trend analysis or a Bayesian model was applied. EuBIVAS has so far delivered BV estimates for 80 different measurands. Estimates for 10 measurands (non-HDL cholesterol, S100-β protein, neuron-specific enolase, soluble transferrin receptor, intact fibroblast growth-factor-23, uncarboxylated-unphosphorylated matrix-Gla protein, human epididymis protein-4, free, conjugated and %free prostate-specific antigen), prior to EuBIVAS, have not been available. BV data for creatinine and troponin I were obtained using two analytical methods in each case. The EuBIVAS has delivered high-quality BV data for a wide range of measurands. The BV estimates are for many measurands lower than those previously reported, having an impact on the derived analytical performance specifications and reference change values. |
| Databáze: | OpenAIRE |
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