Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations

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 analyti...

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Bibliographic Details
Published in:Nutrients Vol. 13; no. 2; p. 431
Main Authors: Cavalier, Etienne, Fraser, Callum, Bhattoa, Harjit, Heijboer, Annemieke, Makris, Konstantinos, Ulmer, Candice, Vesper, Hubert, Vasikaran, Samuel, Lukas, Pierre, Delanaye, Pierre, Carobene, Anna
Format: Journal Article
Language:English
Published: Switzerland MDPI AG 28.01.2021
Multidisciplinary Digital Publishing Institute (MDPI)
MDPI
Subjects:
25(OH)-vitamin D
analytical performance specifications biological variation
Bias
Biological variation
Blood banks
blood sampling
Blood Specimen Collection
Calibration
Collections
Data analysis
Disease control
dissection
Ethylenediaminetetraacetic acid
Human health sciences
Humans
Immunoassay
Japan
Laboratory medicine & medical technology
Linear Models
Males
measurement
measurement uncertainty
Medical laboratories
Medical research
Medicine
Medicine, Experimental
Models, Theoretical
Médecine de laboratoire & technologie médicale
regression analysis
Sciences de la santé humaine
Standardization
Uncertainty
Urologie & néphrologie
Urology & nephrology
Variance analysis
Vitamin D
Vitamin D - analogs & derivatives
Vitamin D - analysis
Vitamin D - blood
Italy
Netherlands
Turkey
Norway
Spain
analytical performance specifications biological variation
measurement uncertainty
25(OH)-vitamin D
vitamin D
ISSN:2072-6643, 2072-6643
Online Access:Get full text
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Summary: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.
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scopus-id:2-s2.0-85100108778
These authors contributed equally to this work.
Membership of the IFCC-IOF Committee for Bone Metabolism is provided in the Acknowledgments.
ISSN:2072-6643
2072-6643
DOI:10.3390/nu13020431