Full Papers
Evaluation of particle-based multi-analyte technology for autoantibody detection in systemic sclerosis: concordance with conventional methods and clinical associations
A. Pérez-Isidro1, G.-M. Lledó-Ibañez2, S. Prieto-González3, F. Hernández-González4, C. Andalucia5, M.A. Aure6, C. Mules7, N. De Moner8, O. Viñas9, G. Espinosa10, E. Ruiz-Ortiz11
- Immunology Department, Centre de Diagnòstic Biomèdic (CDB), Hospital Clínic, Barcelona; and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
- Autoimmune Diseases Department, Reference Centre for Systemic Autoimmune Diseases, Vasculitis and Autoinflammatory Diseases of the Catalan and Spanish Health Systems, Member of the European Reference Centres (ERN) Re-CONNET and RITA, Hospital Clínic, Barcelona, Spain.
- Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona; Autoimmune Diseases Department, Reference Centre for Systemic Autoimmune Diseases, Vasculitis and Autoinflammatory Diseases of the Catalan and Spanish Health Systems, Member of the European Reference Centres (ERN) Re-CONNET and RITA, Hospital Clínic, Barcelona; and Internal Medicine Department, Hospital Clínic, Barcelona, Spain.
- Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona; and Department of Respiratory Medicine, Respiratory Institute, Hospital Clinic Barcelona, Spain.
- Research and Development, Headquarters and Technology Center, Autoimmunity, Werfen, San Diego, CA, USA.
- Research and Development, Headquarters and Technology Center, Autoimmunity, Werfen, San Diego, CA, USA.
- Research and Development, Headquarters and Technology Center, Autoimmunity, Werfen, San Diego, CA, USA.
- Immunology Department, Centre de Diagnòstic Biomèdic (CDB), Hospital Clínic, Barcelona, Spain.
- Immunology Department, Centre de Diagnòstic Biomèdic (CDB), Hospital Clínic, Barcelona; and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
- Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona; and Autoimmune Diseases Department, Reference Centre for Systemic Autoimmune Diseases, Vasculitis and Autoinflammatory Diseases of the Catalan and Spanish Health Systems, Member of the European Reference Centres (ERN) Re-CONNET and RITA, Hospital Clínic, Barcelona, Spain. gespino@clinic.cat
- Immunology Department, Centre de Diagnòstic Biomèdic (CDB), Hospital Clínic, Barcelona; and Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
CER19515
Full Papers
PMID: 42024550 [PubMed]
Received: 10/11/2025
Accepted : 19/01/2026
In Press: 20/04/2026
Abstract
OBJECTIVES:
To evaluate the clinical performance of particle-based multi-analyte technology (PMAT) for the detection of systemic sclerosis (SSc)-associated autoantibodies and to explore correlations between antibody profiles and disease manifestations.
METHODS:
We assessed PMAT performance in 124 SSc patients fulfilling the 2013 ACR/EULAR criteria, 205 disease controls, and 25 healthy individuals. All samples were tested for a broad autoantibody panel, including both classification and non-criteria autoantibodies. Concordance with conventional methods (chemiluminescence and ELISA) and associations with clinical features were analysed.
RESULTS:
PMAT showed excellent agreement with established techniques for anti-centromere autoantibodies (ACA) (κ=0.95) and anti-topoisomerase I (anti-Topo I) (κ=0.95), and good agreement for anti-RNA polymerase III autoantibodies (anti-RNApol III) (κ=0.78), confirming its reliability in detecting major SSc autoantibodies. The most prevalent autoantibodies were ACA (54.0%), anti-Topo I (21.0%), and anti-RNApol III (5.7%), each associated with distinct clinical phenotypes: ACA with limited cutaneous SSc and absence of interstitial lung disease (ILD); anti-Topo I with diffuse cutaneous SSc, ILD, and scleroderma renal crisis; and anti-RNApol III with digital ulcers and calcinosis. Importantly, novel associations were identified between PUF60 isoform 6 and severe ILD, and between PUF60 isoform 1 and the sine scleroderma phenotype, suggesting their potential as emerging biomarkers.
CONCLUSIONS:
These findings support the diagnostic and clinical utility of comprehensive serological profiling and the integration of PMAT into routine diagnostic workflows. The identification of novel autoantibody-phenotype associations underscore the value of multiplex technologies in advancing precision medicine for SSc.
