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Standardisation of PR3-ANCA and MPO-ANCA: evaluation of certified reference materials
  1. Xavier Bossuyt1,
  2. Doreen Dillaerts1,
  3. Michael Mahler2,
  4. Dirk Roggenbuch3,4,
  5. Ulrich Leinfelder5,
  6. Friederike Hammar5,
  7. Wolfgang Schlumberger6,
  8. Nina Olschowka7,
  9. Jan Damoiseaux8
  1. 1 Department of Microbiology and Immunology, KU Leuven and Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium
  2. 2 INOVA Diagnostics, San Diego, California, USA
  3. 3 Medipan GmbH, Dahlewitz/Berlin, Germany
  4. 4 Faculty of Health Sciences, Joint Faculty of the Brandenburg University of Technology Cottbus - Senftenberg, the Brandenburg Medical School Theodor Fontane and the University of Potsdam, Brandenburg, Germany
  5. 5 Orgentec Diagnostika GmbH, Mainz, Germany
  6. 6 Euroimmun AG, Lubeck, Germany
  7. 7 Thermo Fisher Scientific, Phadia GmbH, Freiburg, Germany
  8. 8 Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, Netherlands
  1. Correspondence to Dr Xavier Bossuyt, KU Leuven University Hospitals Leuven, 3000 Leuven, Belgium; xavier.bossuyt{at}

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Antineutrophil cytoplasmic antibodies (ANCAs) are important laboratory markers to support the diagnosis of ANCA-associated vasculitis. A 2017 international consensus states that high-quality immunoassays for proteinase-3 (PR3)-ANCA and myeloperoxidase (MPO)-ANCA can be used as the primary screening method for patients suspected of having granulomatosis with polyangiitis or microscopic polyangiitis.1

Efforts have been undertaken to standardise PR3-ANCA and MPO-ANCA measurements. More than 10 years ago, PR3-ANCA and MPO-ANCA reference standards have been prepared (from single patients) under the umbrella of the International Union of Immunological Societies (IUIS) and are available through the Autoantibody Standardization Committee ( Several companies are using these reference standards (assigned value: 100 IU/mL) to calibrate their assays, such as Svar Life Science (ELISA), Thermo Fisher Scientific (fluoroenzyme immunoassay (FEIA)), Medipan (CytoBead assay) and Inova Diagnostics (chemiluminescence assay (CLIA)).

The Institute for Reference Materials and Measurements (IRMM) recently released certified reference materials for MPO-ANCA (ERM-DA476/IFCC) and for PR3-ANCA (ERM-DA483/IFCC).2 3 Both reference materials are based on plasmapheresis samples from single patients. We evaluated whether using the IRMM-certified reference materials aligns results for PR3-ANCA and MPO-ANCA across assays.

A random selection of 98 serum samples covering low, medium and high PR3-ANCA or MPO-ANCA levels from the Leuven and the Maastricht cohort included in the international EUVAS study4 were distributed to five manufacturers, together with the PR3-ANCA and …

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  • Handling editor Josef S Smolen

  • Contributors XB and JD designed the study. DD analysed the data. MM, DR, UL, FH, WS and NO helped with the analyses. All authors reviewed the manuscript and provided input.

  • Funding This study was funded by Euroimmun AG, Inova Diagnostics, Medipan GmbH, Orgetec Diagnostika GmbH, Thermo Fisher Scientific.

  • Competing interests XB has received speaker fees from Thermo Fisher Scientific and Inova, has been a consultant for Thermo Fisher Scientific and Inova and has received research support from Thermo Fisher Scientific. JD has received speaker fees from Thermo Fisher Scientific, Euroimmun and Inova. MM is employed by Inova Diagnostics, WS received personal fees from Euroimmun, NO is employed by Thermo Fisher Scientific, FH and UL are employed by Orgentec, DR received personal fees from Medipan and Generic Assays.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.