Aasne K Aarsand1,2,3, Jorge Díaz-Garzón4, Pilar Fernandez-Calle3,4, Elena Guerra5, Massimo Locatelli5, William A Bartlett3,6, Sverre Sandberg7,2,3, Thomas Røraas2,3, Ferruccio Ceriotti8, Una Ørvim Sølvik2,9, Marit Sverresdotter Sylte7, Abdurrahman Coşkun3,10, Mustafa Serteser10, Ibrahim Unsal10, Francesca Tosato11, Mario Plebani11, Niels Jonker3,12, Gerhard Barla12, Anna Carobene3,5. 1. Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway; aasne.aarsand@helse-bergen.no. 2. Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway. 3. Working Group on Biological Variation, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy. 4. Hospital Universitario La Paz, Madrid, Spain, and Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC), Barcelona, Spain. 5. Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Milan, Italy. 6. Blood Sciences, Ninewells Hospital & Medical School, Dundee, UK. 7. Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. 8. Central Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. 9. Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. 10. Acibadem University, School of Medicine, Atasehir, Istanbul, Turkey. 11. Department of Laboratory Medicine University Hospital, Padua, Italy. 12. Certe, Wilhelmina Ziekenhuis Assen, Assen, the Netherlands.
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.
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.
Authors: Michela Bottani; Giuseppe Banfi; Elena Guerra; Massimo Locatelli; Aasne K Aarsand; Abdurrahman Coşkun; Jorge Díaz-Garzón; Pilar Fernandez-Calle; Sverre Sandberg; Ferruccio Ceriotti; Elisabet González-Lao; Margarita Simon; Anna Carobene Journal: Ann Transl Med Date: 2020-07
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