Article (Scientific journals)
European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates of β-isomerized C-terminal telopeptide of type I collagen (β-CTX), N-terminal propeptide of type I collagen (PINP), osteocalcin, intact fibroblast growth factor 23 and uncarboxylated-unphosphorylated matrix-Gla protein—a cooperation between the EFLM Working Group on Biological Variation and the International Osteoporosis Foundation-International Federation of Clinical Chemistry Committee on Bone Metabolism
Cavalier, Etienne; LUKAS, Pierre; Bottani, M. et al.
2020In Osteoporosis International, 31 (8), p. 1461-1470
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Keywords :
Biological variation; Bone markers; CTX; FGF23; MGP; Osteocalcin; PINP; Reference change value
Abstract :
[en] Summary: We have calculated the biological variation (BV) of different bone metabolism biomarkers on a large, well-described cohort of subjects. BV is important to calculate reference change value (or least significant change) which allows evaluating if the difference observed between two consecutive measurements in a patient is biologically significant or not. Introduction: Within-subject (CVI) and between-subject (CVG) biological variation (BV) estimates are essential in determining both analytical performance specifications (APS) and reference change values (RCV). Previously published estimates of BV for bone metabolism biomarkers are generally not compliant with the most up-to-date quality criteria for BV studies. We calculated the BV and RCV for different bone metabolism markers, namely β-isomerized C-terminal telopeptide of type I collagen (β-CTX), N-terminal propeptide of type I collagen (PINP), osteocalcin (OC), intact fibroblast growth factor 23 (iFGF-23), and uncarboxylated-unphosphorylated Matrix-Gla Protein (uCuP-MGP) using samples from the European Biological Variation Study (EuBIVAS). Methods: In the EuBIVAS, 91 subjects were recruited from six European laboratories. Fasting blood samples were obtained weekly for ten consecutive weeks. The samples were run in duplicate on IDS iSYS or DiaSorin Liaison instruments. The results were subjected to outlier and variance homogeneity analysis before CV-ANOVA was used to obtain the BV estimates. Results: We found no effect of gender upon the CVI estimates. The following CVI estimates with 95% confidence intervals (95% CI) were obtained: β-CTX 15.1% (14.4–16.0%), PINP 8.8% (8.4–9.3%), OC 8.9% (8.5–9.4%), iFGF23 13.9% (13.2–14.7%), and uCuP-MGP 6.9% (6.1–7.3%). Conclusions: The EuBIVAS has provided updated BV estimates for bone markers, including iFGF23, which have not been previously published, facilitating the improved follow-up of patients being treated for metabolic bone disease. © 2020, International Osteoporosis Foundation and National Osteoporosis Foundation.
Disciplines :
Public health, health care sciences & services
Author, co-author :
Cavalier, Etienne  ;  Université de Liège - ULiège > Département de pharmacie > Chimie médicale
LUKAS, Pierre  ;  Centre Hospitalier Universitaire de Liège - CHU > Unilab > Bone and cartilage markers laboratory
Bottani, M.;  IRCCS Istituto Ortopedico Galeazzi, Laboratory of Experimental Biochemistry & Molecular Biology, Milan, Italy
Aarsand, A. K.;  Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway, Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway, Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy
Ceriotti, F.;  Clinical Laboratory, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy
Coşkun, A.;  Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Atasehir, Istanbul, Turkey
Díaz-Garzón, J.;  Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy, Quality Analytical Commission of Spanish Society of Laboratory Medicine (SEQC-ML), Hospital Universitario La Paz, Madrid, Spain
Fernàndez-Calle, P.;  Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy, Quality Analytical Commission of Spanish Society of Laboratory Medicine (SEQC-ML), Hospital Universitario La Paz, Madrid, Spain
Guerra, E.;  Laboratory Medicine, Ospedale San Raffaele, Milan, Italy
Locatelli, M.;  Laboratory Medicine, Ospedale San Raffaele, Milan, Italy
Sandberg, S.;  Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway, Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway, Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
Carobene, A.;  Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Milan, Italy, Laboratory Medicine, Ospedale San Raffaele, Milan, Italy
Åkesson, K.
Bhattoa, H. P.
Bruyère, Olivier  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Cooper, C.
Eastell, R.
Garnero, P.
Heijboer, A.
Jorgensen, N. R.
Kanis, J.
Makris, K.
Ulmer, C. Z.
Vasikaran, S.
on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation and IOF-IFCC Committee on Bone Metabolism
More authors (15 more) Less
Language :
English
Title :
European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates of β-isomerized C-terminal telopeptide of type I collagen (β-CTX), N-terminal propeptide of type I collagen (PINP), osteocalcin, intact fibroblast growth factor 23 and uncarboxylated-unphosphorylated matrix-Gla protein—a cooperation between the EFLM Working Group on Biological Variation and the International Osteoporosis Foundation-International Federation of Clinical Chemistry Committee on Bone Metabolism
Publication date :
2020
Journal title :
Osteoporosis International
ISSN :
0937-941X
eISSN :
1433-2965
Publisher :
Springer
Volume :
31
Issue :
8
Pages :
1461-1470
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 13 August 2020

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