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Clinically relevant discrepancies between different rheumatoid factor assays
Open accessAbstract
Abstract Background: Accurate measurements of rheumatoid factors (RFs), autoantibodies binding IgG, are important for diagnosing rheumatoid arthritis (RA) and for predicting disease course. Worldwide, various RF assays are being used that differ in technique and target antigens. We studied whether assay choice leads to clinically important discrepancies in RF status and level. Methods: RF measurements using four commercial RF assays were compared in 32 RF + samples. Using enzyme-linked immunosorbent assays (ELISAs), the influence of the target antigen source – human IgG (hIgG) versus rabbit IgG (rIgG) – on measured RF levels was investigated in arthralgia patients and RA patients. Results: Substantial discrepancies were found between RF levels measured in the four commercial assays. Six samples (19%) with RF levels below or slightly above the cutoff in the rIgG-based Phadia assay were RF + in three assays using hIgG as the target antigen, some with very high levels. Direct ELISA comparisons of RF reactivity against hIgG and rIgG estimated that among 173 ACPA + arthralgia patients, originally RF negative in rIgG-based assays, up to 10% were single positive against hIgG. Monoclonal RFs binding to hIgG and rIgG or hIgG only supported these findings. In a cohort of 69 early RA patients, virtually all RF responses reacted with both targets, although levels were still variable. Conclusions: The use of RF assays that differ in technique and target antigen, together with the different specificities of RF responses, leads to discrepancies in RF status and levels. This has important consequences for patient care if RA diagnosis and disease progression assessments are based on RF test results.
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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 [73]
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Metadata
- Authors
- Falkenburg, W. J. J., von Richthofen, H. J., Koers, J., Weykamp, C., Schreurs, M. W. J., Bakker-Jonges, L. E., Haagen, I.-A., Lems, W. F., Hamann, D., van Schaardenburg, D., & Rispens, T.
- Affiliations
- Sanquin (NL)
- Department of Immunopathology, Sanquin Research , Amsterdam , The Netherlands
- Streekziekenhuis Koningin Beatrix (NL)
- Erasmus MC (NL)
- Medical Laboratories , Department of Immunology, Reinier de Graaf Groep , Delft , The Netherlands
- OLVG (NL)
- Reade (NL)
- Amsterdam Rheumatology and Immunology Center , Reade, Amsterdam , The Netherlands
- Amsterdam UMC Location University of Amsterdam (NL)
- Corresponding author
- Falkenburg, Willem J.J.
- Rispens, Theo
- Venue
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Publisher
- Walter de Gruyter GmbH
- Published
- 2018-02-10
- Volume
- 56
- Issue
- 10
- Pages
- 1749-1758
- ISSN
- 1434-6621 (ISSN-L)
- 1437-4331
- OpenAlex
- W2790420596
- Cited by
- 30
- References
- 44
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 2 · 2022: 6 · 2021: 4 · 2020: 2 · 2019: 2 · 2018: 6
- FWCI
- 3.00
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Chemistry and Laboratory Medicine (CCLM) (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- ZonMw (436001001)
- 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 factor, assay discrepancy, target antigens, human IgG, rabbit IgG, anti-citrullinated protein antibodies, joint pain, early rheumatoid arthritis, autoantibodies
- MeSH terms
- Animals, Antibodies, Monoclonal, Arthritis, Rheumatoid, Enzyme-Linked Immunosorbent Assay, Humans, Immunoglobulin G, Immunoglobulin M, Rabbits, Reagent Kits, Diagnostic, Rheumatoid Factor, Arthralgia
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