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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

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1437-4331
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Volume 54, Issue 1

Issues

Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study

Emmanuel Moreau / Silvia Bächer
  • Institute of Laboratory Medicine, Hospital of the Ludwig-Maximilians-University of Munich, Munich, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Sophie Mery / Caroline Le Goff / Nadia Piga / Michael Vogeser
  • Institute of Laboratory Medicine, Hospital of the Ludwig-Maximilians-University of Munich, Munich, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Michael Hausmann / Etienne Cavalier
Published Online: 2015-06-27 | DOI: https://doi.org/10.1515/cclm-2014-1249

Abstract

Background: The study was conducted to evaluate the analytical and clinical performance of the VIDAS® 25-OH Vitamin D Total assay. The clinical performance of the assay was compared with four other immunoassays against the results of two different liquid chromatography/mass spectrometry methods (LC-MS/MS) standardized to NIST reference materials.

Methods: VIDAS® 25-OH Vitamin D Total assay precision, linearity, detection limits and sample matrix comparison were assessed following CLSI guidelines. For method comparison, a total of 150 serum samples ranging from 7 to 92 ng/mL were analyzed by all the methods. Correlation was studied using Passing-Bablok regression and Bland-Altman analysis. The concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and the reference LC-MS/MS method. In addition, samples containing endogenous 25(OH)D2 were used to assess each immunoassay’s ability to detect this analyte. Pregnancy and hemodialysis samples were used to the study the effect of vitamin D binding protein (DBP) concentration over VIDAS® assay performance.

Results: The VIDAS® 25-OH Vitamin D Total assay showed excellent correlation to the LC-MS/MS results (y=1.01x+0.22 ng/mL, r=0.93), as obtained from two different sites and distinct LC-MS/MS methods. The limit of quantification was determined at 8.1 ng/mL. Cross-reactivity for 25(OH)D2 was over 80%. At concentrations of 10.5, 26 and 65.1 ng/mL, within-run CVs were 7.9%, 3.6% and 1.7%, while total CVs (between runs, calibrations, lots and instruments) were 16.0%, 4.5% and 2.8%. The VIDAS® performance was not influenced by altered DBP levels, though under-recovery of 25(OH)D as compared to LC-MS/MS was observed for hemodialysis samples.

Conclusions: The VIDAS® 25-OH Vitamin D Total assay is therefore considered suitable for assessment of vitamin D status in clinical routine.

This article offers supplementary material which is provided at the end of the article.

Keywords: assay performance; liquid chromatography/mass spectrometry; standardization; 25-OH vitamin D

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About the article

Corresponding author: Emmanuel Moreau, bioMérieux, R&D Immunoassays, Marcy l’Etoile, France, E-mail:


Received: 2014-12-16

Accepted: 2015-05-22

Published Online: 2015-06-27

Published in Print: 2016-01-01


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Etienne Cavalier is consultant for IDS and Diasorin and has received lecture fees from Abbott, IDS, DiaSorin and Roche. Michael Vogeser has received research funding from Institut Mérieux.

Employment or leadership: Emmanuel Moreau, Nadia Piga and Michael Hausmann are employees of bioMerieux Inc.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 54, Issue 1, Pages 45–53, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-1249.

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