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Journal of Laboratory Medicine

Official Journal of the German Society of Clinical Chemistry and Laboratory Medicine

Editor-in-Chief: Schuff-Werner, Peter

Ed. by Ahmad-Nejad, Parviz / Bidlingmaier, Martin / Bietenbeck, Andreas / Conrad, Karsten / Findeisen, Peter / Fraunberger, Peter / Ghebremedhin, Beniam / Holdenrieder, Stefan / Kiehntopf, Michael / Klein, Hanns-Georg / Kohse, Klaus P. / Kratzsch, Jürgen / Luppa, Peter B. / Meyer, Alexander von / Nebe, Carl Thomas / Orth, Matthias / Röhrig-Herzog, Gabriele / Sack, Ulrich / Steimer, Werner / Weber, Thomas / Wieland, Eberhard / Winter, Christoph / Zettl, Uwe K.


IMPACT FACTOR 2018: 0.389

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Volume 37, Issue 5

Issues

The importance of assays in vitamin D status classification: a comparison of four automated 25-hydroxyvitamin D immunoassays

Die Labormethodik hat einen großen Einfluss auf die Klassifikation des Vitamin D Status: ein Vergleich von vier automatisierten Immuno-Assays

Johannes Schmid
  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • Andreas Tomaschitz and Stefan Pilz contributed equally to this work.
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/ Katharina Kienreich
  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • Andreas Tomaschitz and Stefan Pilz contributed equally to this work.
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/ Martin Gaksch
  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
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/ Martin Grübler
  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
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/ Reinhard Raggam
  • Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria
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/ Andreas Meinitzer
  • Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria
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/ Femke Rutters
  • Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
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/ Jacqueline M. Dekker
  • Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
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/ Winfried März
  • Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria
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/ Nicolas Verheyen
  • Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
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/ Andreas Tomaschitz
  • Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • Andreas Tomaschitz and Stefan Pilz contributed equally to this work.
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/ Stefan Pilz
  • Corresponding author
  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands
  • Andreas Tomaschitz and Stefan Pilz contributed equally to this work.
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Published Online: 2013-08-09 | DOI: https://doi.org/10.1515/labmed-2012-0074

Abstract

Background: Owing to a growing interest in vitamin D, there has been an increasing demand for 25-hydroxyvitamin D (25[OH]D) measurements over the past few years warranting a critical evaluation of laboratory methods for 25(OH)D determinations. Therefore, the aim of this study was to compare four of the most frequently used routine assays for 25(OH)D.

Methods: In 106 hypertensive patients (53±14 years; 59% females), derived from the Graz Endocrine Causes of Hypertension (GECOH) study, we measured 25(OH)D in serum and plasma by means of four automated immunoassays (DiaSorin Liaison, IDS iSYS, Abbott ARCHITECT, and Roche Cobas).

Results: We observed a poor comparability between assay results with Pearson correlation coefficients between the different methods ranging from 0.57 to 0.85. Using a value of ≤20 ng/mL (50 nmol/L) as the cut-off for vitamin D deficiency, the percentages of vitamin D deficient patients was significantly different depending on the assay method: 79.2% (Abbott ARCHITECT), 50.0% (DiaSorin Liaison), 28.3% (IDS iSYS), and 23.6% (Roche Cobas).

Conclusions: By comparing four frequently used automated immunoassays for 25(OH)D, we observed remarkable differences with a significant impact on vitamin D status classification. Clinicians and researchers must be aware of these assay differences and must aim for standardization of 25(OH)D measurements.

Zusammenfassung

Einleitung: Aufgrund eines steigenden Interesses am Vitamin D kam es in den letzten Jahren zu einer zunehmenden Nachfrage nach Bestimmungen des 25-Hydroxyvitamin D (25[OH]D). Dies erfordert auch eine kritische Evaluierung der Labormethodik, weswegen wir 4 der am häufigsten verwendeten Immuno-assays für das 25(OH)D miteinander verglichen haben.

Methoden: Bei 106 hypertensiven PatientInnen (53±14 Jahren; 59% Frauen) der Graz Endocrine Causes of Hypertension (GECOH) Studie, wurde 25(OH)D im Serum und Plasma mit 4 automatisierten Immuno-Assays gemessen (DiaSorin Liaison, IDS iSYS, Abbott ARCHITECT, and Roche Cobas).

Ergebnisse: Es zeigte sich eine schlechte Vergleichbarkeit zwischen den unterschiedlichen Assays mit Pearson Korrelationskoeffizienten zwischen den unterschiedlichen Methoden von 0,57 bis 0,85. Bei Verwendung eines cut-offs von ≤20 ng/mL (50 nmol/L) für die Definition eines Vitamin D Mangels, schwankte die Prävalenz des Vitamin D Mangels je nach verwendetem Assay: 79.2% (Abbott ARCHITECT), 50.0% (DiaSorin Liaison), 28.3% (IDS iSYS) und 23.6% (Roche Cobas).

Schlussfolgerungen: Bei einem Vergleich von 4 häufig verwendeten automatisierten Immuno-Assays für das 25(OH)D fanden wir signifikante Unterschiede mit deutlichen Auswirkungen auf die Klassifikation des Vitamin D Status. Ärzte und Forscher müssen sich dieser Assay-Unterschiede bewusst sein und man muss unbedingt eine Standardisierung der 25(OH)D Messungen anstreben.

Reviewed publication

MärzW.

Keywords: assay; laboratory; measurement; method; vitamin D; 25(OH)D; Assay; Labor; Messung; Methode; Vitamin D; 25(OH)D

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About the article

Correspondence: Stefan Pilz, MD, PhD, Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Centre Amsterdam, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands, Tel.: +31 650 9103667, Fax: +31 20 444 8181; and Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Graz, Austria


Received: 2013-04-25

Accepted: 2013-07-10

Published Online: 2013-08-09

Published in Print: 2013-09-01


Citation Information: Laboratoriumsmedizin, Volume 37, Issue 5, Pages 261–268, ISSN (Online) 1439-0477, ISSN (Print) 0342-3026, DOI: https://doi.org/10.1515/labmed-2012-0074.

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