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Standardisation of ACPA tests : evaluation of a new candidate reference preparation

Lieve Van Hoovels, Lucy Studholme, Bert Vander Cruyssen, Daniela Sieghart, Carolien Bonroy (UGent) , Eszter Nagy, Rille Pullerits, Sasa Čučnik, Charlotte Dahle, Ingmar Heijnen, et al.
(2022) ANNALS OF THE RHEUMATIC DISEASES. 81(10). p.1379-1384
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Abstract
Introduction Commercial assays measuring antibodies to citrullinated protein/peptide (ACPA) show poor quantitative agreement. The diagnostic industry has never adopted the International Union of Immunological Societies-Centers for Disease Control and Prevention (IUIS-CDC) ACPA reference standard. Recently, the National Institute for Biological Standards and Control (NIBSC) prepared a new candidate ACPA standard (18/204). We evaluated both reference materials using different commercially available ACPA assays. Materials and methods This is an international study in which the NIBSC candidate ACPA standard and the IUIS-CDC ACPA reference material were analysed together with 398 diagnostic samples from individuals with rheumatoid arthritis (RA) and in 1073 individuals who did not have RA using nine commercial ACPA assays. Results For both reference materials and samples from individuals with RA and individuals who did not have RA, there were large differences in quantitative ACPA results between assays. For most assays, values for the IUIS-CDC standard were lower than values for NIBSC 18/204 and the IUIS-CDC/NIBSC ratio was comparable for several, but not all assays. When NIBSC 18/204 was used as a calibrator, an improvement in alignment of ACPA results across several of the evaluated assays was obtained. Moreover, NIBSC 18/204 could align clinical interpretation for some but not all assays. Conclusion Adoption of an international standard for ACPA determination is highly desirable. The candidate NIBSC 18/204 standard improved the standardisation and alignment of most ACPA assays and might therefore be recommended to be used as reference in commercial assays.
Keywords
anti-citrullinated protein antibody, reference material, NIBSC, standardization, CLASSIFICATION, PERFORMANCE, ANTIBODIES, IMPACT, ASSAYS

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MLA
Van Hoovels, Lieve, et al. “Standardisation of ACPA Tests : Evaluation of a New Candidate Reference Preparation.” ANNALS OF THE RHEUMATIC DISEASES, vol. 81, no. 10, 2022, pp. 1379–84, doi:10.1136/annrheumdis-2021-221849.
APA
Van Hoovels, L., Studholme, L., Vander Cruyssen, B., Sieghart, D., Bonroy, C., Nagy, E., … Bossuyt, X. (2022). Standardisation of ACPA tests : evaluation of a new candidate reference preparation. ANNALS OF THE RHEUMATIC DISEASES, 81(10), 1379–1384. https://doi.org/10.1136/annrheumdis-2021-221849
Chicago author-date
Van Hoovels, Lieve, Lucy Studholme, Bert Vander Cruyssen, Daniela Sieghart, Carolien Bonroy, Eszter Nagy, Rille Pullerits, et al. 2022. “Standardisation of ACPA Tests : Evaluation of a New Candidate Reference Preparation.” ANNALS OF THE RHEUMATIC DISEASES 81 (10): 1379–84. https://doi.org/10.1136/annrheumdis-2021-221849.
Chicago author-date (all authors)
Van Hoovels, Lieve, Lucy Studholme, Bert Vander Cruyssen, Daniela Sieghart, Carolien Bonroy, Eszter Nagy, Rille Pullerits, Sasa Čučnik, Charlotte Dahle, Ingmar Heijnen, Luca Bernasconi, Farid Benkhadra, Laura Bogaert, Stefanie Van Den Bremt, Ann Van Liedekerke, Geert Vanheule, Johan Robbrecht, Claudine Wirth, Rüdiger Müller, Diego Kyburz, Christopher Sjöwall, Alf Kastbom, Rok Ješe, Boja Jovancevic, Emese Kiss, Peggy Jacques, Daniel Aletaha, Günter Steiner, Patrick Verschueren, and Xavier Bossuyt. 2022. “Standardisation of ACPA Tests : Evaluation of a New Candidate Reference Preparation.” ANNALS OF THE RHEUMATIC DISEASES 81 (10): 1379–1384. doi:10.1136/annrheumdis-2021-221849.
Vancouver
1.
Van Hoovels L, Studholme L, Vander Cruyssen B, Sieghart D, Bonroy C, Nagy E, et al. Standardisation of ACPA tests : evaluation of a new candidate reference preparation. ANNALS OF THE RHEUMATIC DISEASES. 2022;81(10):1379–84.
IEEE
[1]
L. Van Hoovels et al., “Standardisation of ACPA tests : evaluation of a new candidate reference preparation,” ANNALS OF THE RHEUMATIC DISEASES, vol. 81, no. 10, pp. 1379–1384, 2022.
@article{01GTHNX77HNPP7WFZGRB9B9NBQ,
  abstract     = {{Introduction Commercial assays measuring antibodies to citrullinated protein/peptide (ACPA) show poor quantitative agreement. The diagnostic industry has never adopted the International Union of Immunological Societies-Centers for Disease Control and Prevention (IUIS-CDC) ACPA reference standard. Recently, the National Institute for Biological Standards and Control (NIBSC) prepared a new candidate ACPA standard (18/204). We evaluated both reference materials using different commercially available ACPA assays. Materials and methods This is an international study in which the NIBSC candidate ACPA standard and the IUIS-CDC ACPA reference material were analysed together with 398 diagnostic samples from individuals with rheumatoid arthritis (RA) and in 1073 individuals who did not have RA using nine commercial ACPA assays. Results For both reference materials and samples from individuals with RA and individuals who did not have RA, there were large differences in quantitative ACPA results between assays. For most assays, values for the IUIS-CDC standard were lower than values for NIBSC 18/204 and the IUIS-CDC/NIBSC ratio was comparable for several, but not all assays. When NIBSC 18/204 was used as a calibrator, an improvement in alignment of ACPA results across several of the evaluated assays was obtained. Moreover, NIBSC 18/204 could align clinical interpretation for some but not all assays. Conclusion Adoption of an international standard for ACPA determination is highly desirable. The candidate NIBSC 18/204 standard improved the standardisation and alignment of most ACPA assays and might therefore be recommended to be used as reference in commercial assays.}},
  author       = {{Van Hoovels, Lieve and Studholme, Lucy and Vander Cruyssen, Bert and Sieghart, Daniela and Bonroy, Carolien and Nagy, Eszter and Pullerits, Rille and Čučnik, Sasa and Dahle, Charlotte and Heijnen, Ingmar and Bernasconi, Luca and Benkhadra, Farid and Bogaert, Laura and Van Den Bremt, Stefanie and Van Liedekerke, Ann and Vanheule, Geert and Robbrecht, Johan and Wirth, Claudine and Müller, Rüdiger and Kyburz, Diego and Sjöwall, Christopher and Kastbom, Alf and Ješe, Rok and Jovancevic, Boja and Kiss, Emese and Jacques, Peggy and Aletaha, Daniel and Steiner, Günter and Verschueren, Patrick and Bossuyt, Xavier}},
  issn         = {{0003-4967}},
  journal      = {{ANNALS OF THE RHEUMATIC DISEASES}},
  keywords     = {{anti-citrullinated protein antibody,reference material,NIBSC,standardization,CLASSIFICATION,PERFORMANCE,ANTIBODIES,IMPACT,ASSAYS}},
  language     = {{eng}},
  number       = {{10}},
  pages        = {{1379--1384}},
  title        = {{Standardisation of ACPA tests : evaluation of a new candidate reference preparation}},
  url          = {{http://doi.org/10.1136/annrheumdis-2021-221849}},
  volume       = {{81}},
  year         = {{2022}},
}
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