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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 / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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IMPACT FACTOR 2017: 3.556

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1437-4331
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Volume 56, Issue 6

Issues

Screening for connective tissue disease-associated antibodies by automated immunoassay

Philippe Willems / Ellen De Langhe / Jolien Claessens / René Westhovens / Erna Van Hoeyveld / Koen Poesen / Steven Vanderschueren
  • General Internal Medicine, University Hospitals Leuven, Leuven, Belgium
  • Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Daniel Blockmans
  • General Internal Medicine, University Hospitals Leuven, Leuven, Belgium
  • Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium
  • Other articles by this author:
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/ Xavier Bossuyt
  • Corresponding author
  • Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium
  • Laboratory Medicine, University Hospitals Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium, Phone: +32 16 347009, Fax: +32 16 34 79 31
  • Email
  • Other articles by this author:
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Published Online: 2018-01-08 | DOI: https://doi.org/10.1515/cclm-2017-0905

Abstract

Background:

Antinuclear antibodies (ANAs) are useful for the diagnosis of ANA-associated systemic rheumatic disease (AASRD). The objective of this study was the evaluation of an immunoassay that detects antibodies to a mixture of 17 antigens as an alternative to indirect immunofluorescence (IIF).

Methods:

Nine thousand eight hundred and fifty-six consecutive patients tested for ANAs were tested by IIF and EliA connective tissue disease screen (Thermo-Fisher). Medical records were reviewed for 2475 patients, including all patients that tested positive/equivocal by either test and a selection of 500 patients that tested negative.

Results:

Concordance between IIF and EliA was 83.1%. AASRD was found in 12.8% of IIF-positive patients, 30.2% of EliA-positive patients and 0.4%, 46.6%, 5.8% and 3.0% of patients that tested, respectively, double negative, double positive, single positive for EliA and single positive for IIF. The association with AASRD increased with increasing antibody level. IIF and EliA were positive in, respectively, 90.4% and 69.9% of systemic lupus erythematosus (n=83), 100% and 84.1% of systemic sclerosis (n=63), 86.7% and 93.3% of Sjögren’s syndrome (n=45), 88.2% and 52.9% of polymyositis/dermatomyositis (n=17), and in all cases of mixed connective tissue disease (n=8). The specificity was projected to be 94%–96% for EliA and 86% for IIF. When all AASRDs were taken together, the areas under the curve of receiver operator curves were similar between IIF and EliA.

Conclusions:

The positive predictive value for AASRD was higher for EliA than for IIF, but, depending on the disease, EliA might fail to detect antibodies that are detected by IIF. Combining immunoassay with IIF adds value.

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

Keywords: antinuclear antibodies; autoantibody(ies); autoimmune diseases; enzyme immunoassay; indirect immunofluorescence

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About the article

Received: 2017-10-08

Accepted: 2017-11-22

Published Online: 2018-01-08

Published in Print: 2018-05-24


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

Research funding: Part of the analyses (identification of specific CENP, RNA polymerase III, PM-Scl, fibrillarin, Mi-2, SSA-52, PCNA and Rib-P antibodies) were performed at Thermo Fisher, Freiburg, Germany. Xavier Bossuyt has received lecture fees from Thermo Fisher.

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 56, Issue 6, Pages 909–918, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0905.

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