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Article

Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations

1
CHU de Liège and Centre de Recherche Intégré sur les Médicaments (CIRM), Department of Clinical Chemistry, University of Liège, Domaine du Sart-Tilman, B-4000 Liège, Belgium
2
Centre for Research into Cancer Prevention and Screening, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, UK
3
Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, H-4032 Debrecen, Hungary
4
Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam Gastroenterology & Metabolism, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam UMC, 1081 HVAmsterdam, The Netherlands
5
Clinical Biochemistry Department, KAT General Hospital, GR-14561 Athens, Greece
6
National Center for Environmental Health, Centers for Disease Control and Prevention, Division of Laboratory Sciences, Atlanta, GA 30329, USA
7
PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch 6150, Australia
8
Department of Nephrology, Dialysis and Transplantation, University of Liege, CHU de Liege, B-4000 Liège, Belgium
9
Department of Nephrology-Dialysis-Apheresis, Hôpital Universitaire Caremeau, 30900 Nîmes, France
10
Laboratory Medicine, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Membership of the IFCC-IOF Committee for Bone Metabolism is provided in the Acknowledgments.
Academic Editor: Giovanni Passeri
Nutrients 2021, 13(2), 431; https://doi.org/10.3390/nu13020431
Received: 5 January 2021 / Revised: 25 January 2021 / Accepted: 25 January 2021 / Published: 28 January 2021
(This article belongs to the Special Issue Benefits of Vitamin D in Health and Diseases)
Currently the 25-hydroxy vitamin D (25(OH)D) concentration is thought to be the best estimate of the vitamin D status of an individual. Unfortunately, its measurement remains complex, despite recent technological advances. We evaluated the biological variation (BV) of 25(OH)D in order to set analytical performance specifications (APS) for measurement uncertainty (MU). Six European laboratories recruited 91 healthy participants. The 25(OH)D concentrations in K3-EDTA plasma were examined weekly for up to 10 weeks in duplicate on a Lumipulse G1200 (Fujirebio, Tokyo, Japan). The linear regression of the mean 25(OH)D concentrations at each blood collection showed that participants were not in a steady state. The dissection of the 10-sample collection into two subsets, namely collections 1–5 and 6–10, did not allow for correction of the lack of homogeneity: estimates of the within-subject BV ranged from 5.8% to 7.1% and the between-subject BV ranged from 25.0% to 39.2%. Methods that would differentiate a difference induced by 25(OH)D supplementation at p < 0.05 should have MU < 13.6%, while at p < 0.01, the MU should be <9.6%. The development of APS using BV assumes a steady state of patients. The findings in this study suggest that patients are not in steady state. Therefore, APS that are based on MU appear to be more appropriate. View Full-Text
Keywords: analytical performance specifications biological variation; measurement uncertainty; vitamin D; 25(OH)-vitamin D analytical performance specifications biological variation; measurement uncertainty; vitamin D; 25(OH)-vitamin D
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MDPI and ACS Style

Cavalier, E.; Fraser, C.G.; Bhattoa, H.P.; Heijboer, A.C.; Makris, K.; Ulmer, C.Z.; Vesper, H.W.; Vasikaran, S.; Lukas, P.; Delanaye, P.; Carobene, A.; on behalf of the IFCC-IOF Committee for Bone Metabolism. Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations. Nutrients 2021, 13, 431. https://doi.org/10.3390/nu13020431

AMA Style

Cavalier E, Fraser CG, Bhattoa HP, Heijboer AC, Makris K, Ulmer CZ, Vesper HW, Vasikaran S, Lukas P, Delanaye P, Carobene A, on behalf of the IFCC-IOF Committee for Bone Metabolism. Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations. Nutrients. 2021; 13(2):431. https://doi.org/10.3390/nu13020431

Chicago/Turabian Style

Cavalier, Etienne, Callum G. Fraser, Harjit P. Bhattoa, Annemieke C. Heijboer, Konstantinos Makris, Candice Z. Ulmer, Hubert W. Vesper, Samuel Vasikaran, Pierre Lukas, Pierre Delanaye, Anna Carobene, and on behalf of the IFCC-IOF Committee for Bone Metabolism. 2021. "Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations" Nutrients 13, no. 2: 431. https://doi.org/10.3390/nu13020431

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