TY - JOUR
T1 - European Biological Variation Study (EuBIVAS)
T2 - within- and between-subject biological variation estimates for serum biointact parathyroid hormone based on weekly samplings from 91 healthy participants
AU - European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation
AU - Bottani, Michela
AU - Banfi, Giuseppe
AU - Guerra, Elena
AU - Locatelli, Massimo
AU - Aarsand, Aasne K
AU - Coşkun, Abdurrahman
AU - Díaz-Garzón, Jorge
AU - Fernandez-Calle, Pilar
AU - Sandberg, Sverre
AU - Ceriotti, Ferruccio
AU - González-Lao, Elisabet
AU - Simon, Margarita
AU - Carobene, Anna
N1 - 2020 Annals of Translational Medicine. All rights reserved.
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
U2 - 10.21037/atm-19-4498
DO - 10.21037/atm-19-4498
M3 - Article
C2 - 32793699
VL - 8
SP - 855
JO - Annals of Translational Medicine
JF - Annals of Translational Medicine
SN - 2305-5839
IS - 14
ER -