Standardisation of ACPA tests: evaluation of a new candidate reference preparation. Issue 10 (13th June 2022)
- Record Type:
- Journal Article
- Title:
- Standardisation of ACPA tests: evaluation of a new candidate reference preparation. Issue 10 (13th June 2022)
- Main Title:
- Standardisation of ACPA tests: evaluation of a new candidate reference preparation
- Authors:
- Van Hoovels, Lieve
Studholme, Lucy
Vander Cruyssen, Bert
Sieghart, Daniela
Bonroy, Carolien
Nagy, Eszter
Pullerits, Rille
Čučnik, Sasa
Dahle, Charlotte
Heijnen, Ingmar
Bernasconi, Luca
Benkhadra, Farid
Bogaert, Laura
Van Den Bremt, Stefanie
Van Liedekerke, Ann
Vanheule, Geert
Robbrecht, Johan
Wirth, Claudine
Müller, Rüdiger
Kyburz, Diego
Sjöwall, Christopher
Kastbom, Alf
Ješe, Rok
Jovancevic, Boja
Kiss, Emese
Jacques, Peggy
Aletaha, Daniel
Steiner, Günter
Verschueren, Patrick
Bossuyt, Xavier - Abstract:
- 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 determinationAbstract : 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. … (more)
- Is Part Of:
- Annals of the rheumatic diseases. Volume 81:Issue 10(2022)
- Journal:
- Annals of the rheumatic diseases
- Issue:
- Volume 81:Issue 10(2022)
- Issue Display:
- Volume 81, Issue 10 (2022)
- Year:
- 2022
- Volume:
- 81
- Issue:
- 10
- Issue Sort Value:
- 2022-0081-0010-0000
- Page Start:
- 1379
- Page End:
- 1384
- Publication Date:
- 2022-06-13
- Subjects:
- anti-citrullinated protein antibody -- reference material -- NIBSC -- standardization
Rheumatism -- Periodicals
616.723005 - Journal URLs:
- http://ard.bmjjournals.com/ ↗
http://www.pubmedcentral.nih.gov/tocrender.fcgi?journal=149&action=archive ↗
http://www.bmj.com/archive ↗
http://gateway.ovid.com/server3/ovidweb.cgi?T=JS&MODE=ovid&D=ovft&PAGE=titles&SEARCH=annals+of+the+rheumatic+diseases.tj&NEWS=N ↗ - DOI:
- 10.1136/annrheumdis-2021-221849 ↗
- Languages:
- English
- ISSNs:
- 0003-4967
- Deposit Type:
- Legaldeposit
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library DSC - BLDSS-3PM
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