ArticleJournal of the peripheral nervous system : JPNS2025
Inter-Laboratory Validation of Nodal/Paranodal Antibody Testing.
Article in Journal of the peripheral nervous system : JPNS, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Anti-Contactin-1-Associated Membranous Nephropathy Presenting With Subsequent Autoimmune Nodopathy.Kidney medicine · 2026Article
- Comparative Analytical Performance of Autoimmune Nodopathy Diagnostic Assays.Annals of laboratory medicine · 2026Article
- A Next-Generation ELISA for the Detection of Anti-(Para)Nodal Antibodies in Autoimmune Nodopathy and COVID-19 Vaccinated Individuals.Journal of the peripheral nervous system : JPNS · 2026Article
- Clinical, Electrophysiologic, and Pathologic Features of Anti-Contactin-Associated Protein 1 Autoimmune Nodopathy.Neurology · 2025Article
- Clinical Spectrum, Pathology, and Mechanisms of Anti-LGI4 Antibody-Positive Autoimmune Nodopathy.Neurology(R) neuroimmunology & neuroinflammation · 2025Article
- Anti-pan-neurofascin IgG3: insights about an emerging autoimmune nodoparanodopathy.Arquivos de neuro-psiquiatria · 2025Review
- Inter-laboratory comparison of a serum fibroblast growth factor receptor 3 (FGFR3) antibody test in sensory neuropathies.Frontiers in immunology · 2025Article
- Membrane Proteome-Wide Screening of Autoantibodies in CIDP Using Human Cell Microarray Technology.Neurology(R) neuroimmunology & neuroinflammation · 2024Article
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
BACKGROUND AND
aimsReliable detection of antibodies against nodal targets is vital for the diagnosis of autoimmune nodopathies. The performance characteristics of recently developed in-house assays are unknown. We compared testing at four centres.
methodsEach submitted 29-40 serum samples to a coordinating centre from one of three groups: (1) autoimmune nodopathy patients, with positive nodal/paranodal antibodies; (2) seronegative patients with other inflammatory neuropathies, and (3) healthy individuals or those with other neurological diseases. The coordinating centre recoded all samples and returned 160 identical aliquots to each testing centre for blinded testing. Once data from all centres had been received by the coordinating centre, unblinded results were returned for analysis. Sensitivity was defined by the proportion of group 1 samples returned as positive. Accuracy was defined as 0.075(sensitivity) + 0.925(specificity).
resultsCentres performed various combinations of ELISA, cell-based (CBAs) and teased-nerve fibre assays. All labs produced highly accurate results (96%-100%) and concordance for the overall result across at least 3 or all 4 test centres was observed for 98% and 89% of the samples respectively. However, 10/30 individual assays (6/14 CBAs and 4/16 ELISAs) were less than 90% sensitive. Only 3 assays had more than 1 false positive result (2 ELISAs and 1 CBA). Combining different assay modalities to produce an overall result did not improve accuracy. Inter-laboratory consistency in the determination of antibody subclasses was poor.
interpretationAlthough most samples were correctly categorised in all 4 centres, the use of a specific test modality or multiple tests did not guarantee accuracy. Early and repeated interlaboratory testing with sharing of samples is important to understand test performance and reproducibility, identify areas for improvement and maintain consistency. To aid this, we provide detailed methods for the best performing tests. Further standardisation of antibody subclass determination is required.
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