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Letter
New WHO ACPA standard enables standardisation among anti-CCP2 assays, but not other ACPA assays using different antigens
  1. Lieve Van Hoovels1,2,
  2. Liesbeth E. Bakker-Jonges3,
  3. Dina Vara4,
  4. Caroline Bijnens5,
  5. Lucy Studholme4,
  6. Daniela Sieghart6,
  7. Bert Vander Cruyssen7,
  8. Patrick Verschueren8,
  9. Guenter Steiner6,9,
  10. Jan G.M.C. Damoiseaux5,
  11. Xavier Bossuyt2,10
  1. 1Department of Laboratory Medicine, OLV Hospital Aast, Aalst, Belgium
  2. 2Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium
  3. 3Reinier Haga Medical Diagnostic Center, Delft, The Netherlands
  4. 4Medicines and Healthcare Regulatory Agency (MHRA), Hertfordshire, UK
  5. 5Laboratory of Clinical Immunology, Maastricht University Medical Center, Maastricht, The Netherlands
  6. 6Internal Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
  7. 7Department of Rheumatology, OLV Hospital Aalst, Aalst, Belgium
  8. 8Department of Rheumatology, KU Leuven University Hospitals Leuven, Leuven, Belgium
  9. 9Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Vienna, Austria
  10. 10Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium
  1. Correspondence to Lieve Van Hoovels, Department of Laboratory Medicine, OLV Hospital Aast, Aalst, Belgium; Lieve.Van.Hoovels{at}olvz-aalst.be

https://doi.org/10.1136/ard-2024-226169

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    Antibodies to citrullinated protein/peptide (ACPA) are established biomarkers for diagnosis and classification of rheumatoid arthritis (RA).1 Different generations of ACPA immunoassays are commercially available, with differences in antigen used (eg, citrullinated recombinant rat filaggrin (CCP1), synthetic cyclic citrullinated peptides (CCP2), multiple citrullinated epitopes (CCP3), and mutated and citrullinated vimentin (MCV)).2 There is poor agreement among commercially available ACPA assays.3 To facilitate comparison between ACPA assays, adoption of an international standard is desirable.

    The International Union for Immunological Societies (IUIS) and Centers for Disease Control and Prevention (CDC) prepared an ACPA reference preparation (www.autoab.org) in 2008, which has not generally been adopted as a reference standard for establishing calibration curves. In 2019, the National Institute for Biological Standards and Control (NIBSC), known as the Medicines and Healthcare Regulatory Agency, developed a standard preparation NIBSC-18/204 for ACPA derived from a serum pool of five patients with RA. Based on the results of a large international study, the WHO acknowledged NIBSC-18/204 as the first WHO International Standard for ACPA.4

    In 2022, we evaluated the NIBSC-18/204 standard using nine commercially available CCP2 assays.5 However, in this study, a CCP3 assay was lacking. In the current …

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    Footnotes

    • Handling editor Josef S Smolen

    • Contributors LVH, XB, JD and LEB-J contributed to the study conception and design. Patient samples were selected by JD, LEB-J and CB. Reference material was provided by MHRA (DV and LS). Material preparation and data collection were performed by JD, LEB-J and CB; data analysis by LVH and XB. Manuscript was prepared by LVH, JD and XB and commented by all authors. The final manuscript was read and approved by all authors. XB acts as the guarantor.

    • Funding Thermo Fisher Scientific donated the ACPA assays and provided technical training and support free of charge.

    • Competing interests LVH, GS and DS have received lecture fees from Thermo Fisher Scientific and have been a consultant for Thermo Fisher Scientific; XB has received lecture fees from Werfen and from Thermo Fisher Scientific; JD has received consultancy and/or speakers fees from Werfen/Inova, ThermoFisher Scientific and Euroimmun.

    • 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.

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