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Performance characteristics of rheumatoid factor and anti-cyclic citrullinated peptide antibody assays may impact ACR/EULAR classification of rheumatoid arthritis
Open accessAbstract
Objectives Rheumatoid factor (RF) and anti-cyclic citrullinated protein/peptide antibodies (ACPA) are integrated in the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for rheumatoid arthritis (RA). The objectives of this study were to evaluate the technical and diagnostic performance of different RF and ACPA assays and to evaluate whether differences in performance impact RA classification.Methods Samples from 594 consecutive patients who for the first time consulted a rheumatologist (44 of whom were diagnosed with RA) and 26 extra newly diagnosed patients with RA were analysed with six different RF assays (Menarini, Thermo Fisher, Inova, Roche, Abbott, Euroimmun) and seven different ACPA assays (Menarini, Thermo Fisher, Inova, Roche, Abbott, Euro Diagnostica, Euroimmun).Results We found differences in analytical performance between assays. There was poor numerical agreement between the different RF and ACPA assays. For all assays, the likelihood ratio for RA increased with increasing antibody levels. The areas under the curve of receiver operating characteristic analysis of the RF (range 0.676-0.709) and ACPA assays (range 0.672-0.769) only differed between some ACPA assays. Nevertheless, using the cut-off proposed by the manufacturer, there was a large variation in sensitivity and specificity between assays (mainly for RF). Consequently, depending on the assay used, a subgroup of patients (13% for RF, 1% for ACPA and 9% for RF/ACPA) might or might not be classified as RA according to the 2010 ACR/EULAR criteria.Conclusion Due to poor harmonisation of RF and ACPA assays and of test result interpretation, RA classification according to 2010 ACR/EULAR criteria may vary when different assays are used.
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Anti-dsDNA tests of differing design may lead to the differential classification of patients, as is the case for other autoantibodies such as rheumatoid factor and anti-CCP antibodies.
“Anti-dsDNA tests of differing design may lead to the differential classification of patients, as is the case for other autoantibodies (e.g., rheumatoid factor and anti-CCP antibodies) (72)(73)(74).”
From Anti-dsDNA Testing Specificity for Systemic Lupus Erythematosus: A Systematic Review. (2022) · cites this paper as [74]
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- Centers for disease control, 2008, Human ACPA serum, Centers for disease control reference reagent for human reference serum for citrullinated peptide/protein antibodies
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Anti-dsDNA Testing Specificity for Systemic Lupus Erythematosus: A Systematic Review.
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Metadata
- Authors
- Van Hoovels, L., Jacobs, J., Vander Cruyssen, B., Van den Bremt, S., Verschueren, P., & Bossuyt, X.
- Affiliations
- Onze Lieve Vrouwziekenhuis Hospital (BE)
- Universitair Ziekenhuis Leuven (BE)
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2018-05
- Volume
- 77
- Issue
- 5
- Pages
- 667-677
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2784454730
- Cited by
- 64
- References
- 28
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 13 · 2023: 9 · 2022: 11 · 2021: 6 · 2020: 6 · 2019: 3 · 2018: 4
- FWCI
- 4.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion, other-oa)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Keywords
- rheumatoid arthritis, rheumatoid factor, anti-CCP antibodies, anti-citrullinated protein antibodies, 2010 ACR/EULAR classification criteria, assay agreement, diagnostic performance, sensitivity and specificity, likelihood ratios, newly diagnosed rheumatoid arthritis, assay harmonization
- MeSH terms
- Anti-Citrullinated Protein Antibodies, Adult, Aged, Aged, 80 and over, Arthritis, Rheumatoid, Female, Humans, Immunoassay, Male, Middle Aged, Rheumatoid Factor, ROC Curve, Sensitivity and Specificity, Reproducibility of Results, Likelihood Functions, Area Under Curve
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