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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 2018: 3.638

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1437-4331
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Volume 55, Issue 3

Issues

Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests

Gellert Karvaly
  • Corresponding author
  • Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary
  • Bionics Innovation Center, Budapest, Hungary
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Katalin Mészáros
  • Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary
  • HAS-SE “Momentum” Hereditary Endocrine Tumours Research Group, Budapest, Hungary
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Krisztián Kovács
  • Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary
  • Bionics Innovation Center, Budapest, Hungary
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Attila Patócs
  • Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary
  • Bionics Innovation Center, Budapest, Hungary
  • HAS-SE “Momentum” Hereditary Endocrine Tumours Research Group, Budapest, Hungary
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Zoltán Sipák / Barna Vásárhelyi
  • Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary
  • Bionics Innovation Center, Budapest, Hungary
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2016-08-15 | DOI: https://doi.org/10.1515/cclm-2016-0536

Abstract

Background:

The systematic evaluation of the clinical concordance of various 25-hydroxyvitamin D (25OHD) testing methods is presented. The need for this approach is raised by the discrepancies in the analytical performance of the available assays.

Methods:

The analytical and clinical performance of six automated 25OHD assays and an in-house liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was investigated. Leftover serum samples (n=162, SA: n=114) were analyzed and all 21 assay combinations were evaluated. The utility of Cohen’s κ values was assessed by transforming them into minimum percentage agreement (MPA). McNemar’s hypothesis test was employed for testing the symmetry of the disagreeing classification outcomes within each method pair.

Results:

Depending on the assay method, the ratio of results classified as positive (<20 ng/mL) was 13.5%–40.0%. The percentage agreement (PA) was 74.1%–92.6%. Compared to other methods, significantly more hypovitaminosis cases were delivered by DiaSorin Liaison® 25 OH vitamin D Total (DL) and significantly fewer by IDS-iSYS 25-Hydroxy Vitamin DS (II). The strongest clinical concordance was exerted by II vs. LC-MS/MS. The κ-derived MPA showed close similarity to the PA scores. McNemar’s tests confirmed the asymmetry of the disagreement in the classification in 14 method combinations.

Conclusions:

The presented approach allows the prediction of the clinical consequences of a 25OHD method transfer. Differences in the clinical classification of assay results are likely encountered when transferring to a new method, even between assays standardized according to the Vitamin D Standardization Program (VDSP) Reference Method Procedure (RMP).

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

Keywords: 25-hydroxyvitamin D; hypovitaminosis D; immunoassay; liquid chromatography-tandem mass spectrometry; method comparison; multicriteria evaluation

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About the article

Corresponding author: Gellert Karvaly, DPharm, PhD, Department of Laboratory Medicine, Semmelweis University, 4 Nagyvárad tér, H-1089 Budapest, Hungary, Phone: +361.2351600/extension 55545, Fax: +361.4591500/extension 55545


Received: 2016-06-19

Accepted: 2016-07-05

Published Online: 2016-08-15

Published in Print: 2017-03-01


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

Research funding: The study was supported by grant ED_14-1-2014-0002.

Employment or leadership: None declared.

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 55, Issue 3, Pages 385–393, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2016-0536.

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