Michela Bottani1, Giuseppe Banfi1,2, Elena Guerra3, Massimo Locatelli3, Aasne K Aarsand4,5, Abdurrahman Coşkun6, Jorge Díaz-Garzón7, Pilar Fernandez-Calle7, Sverre Sandberg4,5,8, Ferruccio Ceriotti9, Elisabet González-Lao10, Margarita Simon11, Anna Carobene3. 1. IRCCS Istituto Ortopedico Galeazzi, Laboratory of Experimental Biochemistry and Molecular Biology, Milan, Italy. 2. Vita-Salute San Raffaele University, Milan, Italy. 3. Laboratory Medicine, Ospedale San Raffaele, Milan, Italy. 4. Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway. 5. Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway. 6. Acibadem Mehmet Ali Aydınlar University, School of Medicine, Atasehir, Istanbul, Turkey. 7. Hospital Universitario La Paz, Madrid, Spain, and Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC), Barcelona, Spain. 8. Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. 9. Central Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. 10. Quality Healthcare Consulting, Grupo ACMS, Barcelona, Spain. 11. Intercomarcal Laboratory Consortiums of Alt Penedès, Anoia and Garraf, Barcelona, Spain.
Abstract
BACKGROUND: The European Biological Variation Study (EuBIVAS) was created by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation to establish high-quality biological variation (BV) estimates for clinically important measurands. In this study, the aim was to deliver reliable BV estimates for the biointact parathyroid hormone (PTH 1-84). METHODS: Serum samples were obtained from a population of 91 healthy individuals (38 men, 43 pre-menopausal women, and 10 post-menopausal women; 21-69 years) from 5 European countries, with all samples stored at -80 °C prior to analysis. PTH 1-84 analysis was performed at the San Raffaele Hospital (Milan, Italy) on the Roche Cobas e801. All samples from each individual were analysed in duplicate within a single run. CV-ANOVA was applied, after analysis of variance homogeneity and outliers, to obtain BV estimates for PTH 1-84 with 95% CIs. RESULTS: The within-subject BV [CVI (95% CI)] estimates were significantly different between men and women [13.0% (12.1-14.2%) and 15.2% (14.3-16.3%), respectively], while the between-subject estimates [CVG (95% CI)] were similar (men: 26.8% (21.4-35.1%), pre-menopausal women: 27.8% (22.7-36.1%)], allowing for delivery of updated analytical performance specifications and reference change values. CONCLUSIONS: Updated BV estimates for serum PTH 1-84 based on the large-scale EuBIVAS may be beneficial for the diagnosis and management of parathyroid glands and bone turnover pathologies. 2020 Annals of Translational Medicine. All rights reserved.
BACKGROUND: The European Biological Variation Study (EuBIVAS) was created by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation to establish high-quality biological variation (BV) estimates for clinically important measurands. In this study, the aim was to deliver reliable BV estimates for the biointact parathyroid hormone (PTH 1-84). METHODS: Serum samples were obtained from a population of 91 healthy individuals (38 men, 43 pre-menopausal women, and 10 post-menopausal women; 21-69 years) from 5 European countries, with all samples stored at -80 °C prior to analysis. PTH 1-84 analysis was performed at the San Raffaele Hospital (Milan, Italy) on the Roche Cobas e801. All samples from each individual were analysed in duplicate within a single run. CV-ANOVA was applied, after analysis of variance homogeneity and outliers, to obtain BV estimates for PTH 1-84 with 95% CIs. RESULTS: The within-subject BV [CVI (95% CI)] estimates were significantly different between men and women [13.0% (12.1-14.2%) and 15.2% (14.3-16.3%), respectively], while the between-subject estimates [CVG (95% CI)] were similar (men: 26.8% (21.4-35.1%), pre-menopausal women: 27.8% (22.7-36.1%)], allowing for delivery of updated analytical performance specifications and reference change values. CONCLUSIONS: Updated BV estimates for serum PTH 1-84 based on the large-scale EuBIVAS may be beneficial for the diagnosis and management of parathyroid glands and bone turnover pathologies. 2020 Annals of Translational Medicine. All rights reserved.
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