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Updated: Jan 28, 2026
10:16
Generation of Two-color Antigen Microarrays for the Simultaneous Detection of IgG and IgM Autoantibodies
Published on: September 15, 2016
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Certified reference material against PR3 ANCA IgG autoantibodies. From development to certification
Evanthia Monogioudi1, Joanna Sheldon2, Pier Luigi Meroni3
1European Commission, Joint Research Centre, Retieseweg 111, 2440 Geel, Belgium, Phone: +32 14 571 906, Fax: +32 14 571 548.
Clinical Chemistry and Laboratory Medicine
|February 22, 2019
Summary
Standardizing immunoassays for anti-neutrophil cytoplasm antibodies (ANCA) is crucial for diagnosing vasculitis. A new certified reference material (CRM) for PR3 ANCA IgG improves assay comparability and diagnostic accuracy.
Area of Science:
- Clinical Chemistry
- Immunology
- Autoantibody Detection
Background:
- Standardization of immunoassays for autoantibodies is critical for accurate disease diagnosis and management.
- Small vessel-associated vasculitis diagnosis relies on detecting autoantibodies like MPO ANCA IgG and PR3 ANCA IgG.
- Significant variability exists in PR3 ANCA IgG measurements across commercially available immunoassays.
Purpose of the Study:
- To assess the potential for improving PR3 ANCA IgG measurement comparability using a certified reference material (CRM).
- To develop and validate a suitable CRM for PR3 ANCA IgG calibration.
Main Methods:
- Evaluation of 30 clinical samples using 10 different immunoassays.
- Pairwise correlation analysis of assay results.
- Feasibility studies to determine the optimal reference material format for CRM preparation.
Main Results:
- Assay result variability can lead to different clinical interpretations for individual samples.
- While most samples showed consistent classification, six samples yielded inconsistent results across assays.
- Systematically good correlation was observed between eight of the ten evaluated assays.
Conclusions:
- A commutable CRM for calibration can enhance the comparability of PR3 ANCA IgG assay results.
- The developed CRM was selected, produced, and certified for its PR3 ANCA IgG content.
- Improved assay standardization facilitates more accurate diagnosis and follow-up of autoimmune diseases.
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