Analytical performance specifications for the measurement uncertainty of 24,25-dihydroxyvitamin D examinations
Author:
Cavalier Etienne1ORCID, Fraser Callum G.2ORCID, Bhattoa Harjit Pal3ORCID, Heijboer Annemieke C.4, Makris Konstantinos5, Vasikaran Samuel6, Huyghebaert Loreen1, Peeters Stéphanie1, Le Goff Caroline1, Herrmann Markus7, Carobene Anna8
Affiliation:
1. Department of Clinical Chemistry , University of Liege, CHU de Liege, CIRM , Liege , Belgium 2. Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School , Dundee , Scotland 3. Department of Laboratory Medicine, Faculty of Medicine , University of Debrecen , Debrecen , Hungary 4. Department of Clinical Chemistry, Endocrine Laboratory , Amsterdam Gastroenterology & Metabolism, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam UMC , Amsterdam , The Netherlands 5. Clinical Biochemistry Department , KAT General Hospital , Athens , Greece 6. PathWest Laboratory Medicine , Fiona Stanley Hospital , Murdoch , WA , Australia 7. Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz , Graz , Austria 8. Laboratory Medicine , IRCCS San Raffaele Scientific Institute , Milan , Italy
Abstract
Abstract
Objectives
The exploration of the metabolites in the degradation pathways of vitamin D (VTD) has gained importance in recent years and simultaneous quantitation of twenty-five-hydroxy vitamin D (25(OH)D) mass concentration together with 24,25-dihydroxyvitamin D (24,25(OH)2D) has been proposed as a newer approach to define VTD deficiency. Yet, no data are available on 24,25(OH)2D biological variation (BV). In this study, we evaluated 24,25(OH)2D’s BV on the European Biological Variation Study (EuBIVAS) cohort samples to determine if analytical performance specifications (APS) for 24,25(OH)2D could be generated.
Methods
Six European laboratories recruited 91 healthy participants. 25(OH)D and 24,25(OH)2D concentrations in K3-EDTA plasma were examined weekly for up to 10 weeks in duplicate with a validated LC-MS/MS method. The Vitamin D Metabolite Ratio (24,25(OH)2D divided by 25(OH)D × 100) was also calculated at each time point.
Results
Linear regression of the mean 24,25(OH)2D concentrations at each blood collection showed participants were not in steady state. Variations of 24,25(OH)2D over time were significantly positively associated with the slopes of 25(OH)D concentrations over time and the concentration of 25(OH)D of the participant at inclusion, and negatively associated with body mass index (BMI), but not with age, gender, or location of the participant. The variation of the 24,25(OH)2D concentration in participants over a 10 weeks period was 34.6%. Methods that would detect a significant change linked to the natural production of 24,25(OH)2D over this period at p<0.05 would need a relative measurement uncertainty (u%)<14.9% while at p<0.01, relative measurement uncertainty should be <10.5%.
Conclusions
We have defined for the first time APS for 24,25(OH)2D examinations. According to the growing interest in this metabolite, several laboratories and manufacturers might aim to develop specific methods for its determination. The results presented in this paper are thus necessary prerequisites for the validation of such methods.
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
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