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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, Christof / Zettl, Uwe K.


IMPACT FACTOR 2018: 0.389

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2567-9449
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Volume 37, Issue 3

Issues

Comparison of modern analyzers for the detection of antiphospholipid antibodies in patients with SLE

Vergleich moderner Analysegeräte für die Bestimmung von Anti-Phospholipid-Antikörpern bei Patienten mit SLE

Diana Vossen / Monika Hofbauer / Jan F. Kersten
  • Department of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Thorsten Krieger / Sven Peine / Kai Gutensohn
Published Online: 2013-05-09 | DOI: https://doi.org/10.1515/labmed-2012-0076

Abstract

Background: The anti-cardiolipin and β2-glycoprotein I antibodies represent the important diagnostic parameters in routine autoimmune screening and represent the important diagnostic criteria for systemic lupus erythematosus (SLE). In this study, five different automated, semiautomated, and manual immunoassays detecting IgG/IgM anti-cardiolipin and anti-β2-glycoprotein I antibodies were tested.

Methods: A total of 43 samples from the patients with SLE diagnosed in the rheumatology outpatient centers in Germany were included in this study.

Results: For anticardiolipin and anti-β2-glycoprotein I, considerable differences in the percentage of the positive results were found between all the five methods, and the itemization of all the positive test results reached only a poor accordance. These findings were confirmed by Cohen’s κ coefficients.

Conclusions: We found a moderate to poor accordance between the five different modern test systems for anticardiolipin and anti-β2-glycoprotein I antibodies. Such discrepancies can result in the clinical misinterpretation of data and may lead to wrong diagnoses. Therefore, further standardization of the tests for the antiphospholipid antibodies (APAs) is required.

Zusammenfassung

Hintergrund: Anti-Cardiolipin und β2-Glykoprotein I Antikörper präsentieren wichtige Parameter in der Routinediagnostik von Autoimmunerkrankungen und stellen ein wesentliches diagnostisches Kriterium für die Diagnose eines systemischen Lupus erythematodes (SLE) dar. In dieser Studie wurden erstmals alle gängigen modernen voll- und teilautomatisierten Analysesysteme hinsichtlich der Bestimmung von anti-Cardiolipin und β2-Glykoprotein I-Antikörpern miteinander verglichen.

Methoden: Es wurden 43 Proben von Patienten mit diagnostiziertem systemischen Lupus erythematodes untersucht.

Ergebnisse: Sowohl bei der Bestimmung von anti-Cardiolipin als auch von β2-Glykoprotein I-Antikörpern zeigten sich signifikante Unterschiede zwischen den verschiedenen Verfahren. Statistisch konnte dies durch Einzelbetrachtung der Ergebnisse mittels des Cohens Kappa-Koeffizienten verdeutlicht werden.

Schlussfolgerung: Unsere Ergebnisse zeigen eine schwache bis fehlende Übereinstimmung der analytischen Resultate bei der Bestimmung von anti-Cardiolipin und von β2-Glykoprotein I-Antikörpern zwischen den aktuellen teil-/ vollautomatisierten Analyzern. Wesentlich für diese Beurteilung war dabei die Betrachtung der Einzelergebnisse und nicht die der gemittelten Gesamtheit. Abweichungen dieses Ausmaßes können in einer klinischen Fehldiagnose und fehlerhaften Therapie resultieren. Eine weitere Standardisierung ist erforderlich.

Keywords: antiphospholipid antibodies; anticardiolipin antibodies; automation; β2-glycoprotein I antibodies; Antiphospholipid-Antikörper; Anti-Cardiolipin-Antikörper; β2-Glykoprotein I-Antikörper

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About the article

Corresponding author: Diana Vossen, cand. med., University Hospital Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany, Tel.: +49 (0)163-5590169, Fax: +49 (0)40-46773009


Received: 2012-11-22

Accepted: 2013-04-02

Published Online: 2013-05-09

Published in Print: 2013-06-01


Citation Information: Laboratoriumsmedizin, Volume 37, Issue 3, Pages 139–145, ISSN (Online) 1439-0477, ISSN (Print) 0342-3026, DOI: https://doi.org/10.1515/labmed-2012-0076.

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