Journal Article DZNE-2026-00306

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A Next-Generation ELISA for the Detection of Anti-(Para)Nodal Antibodies in Autoimmune Nodopathy and COVID-19 Vaccinated Individuals.

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2026
Wiley-Blackwell Oxford [u.a.]

Journal of the peripheral nervous system 31(2), e70117 () [10.1111/jns.70117]

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Abstract: Autoimmune nodopathy (AN) is a subtype of antibody-mediated inflammatory neuropathy targeting the node of Ranvier (NoR). Diagnosis requires detection of anti-(para)nodal autoantibodies like contactin-1 and neurofascin-155 via ELISA or cell-based assays, but protocols are inconsistent. Causes of node autoimmunity are unknown, and respiratory infections, including SARS-CoV-2 infection or COVID-19 vaccination as triggers, have not been thoroughly investigated. We aim to establish and validate a next-generation automated ELISA for anti-(para)nodal antibodies and investigate whether low-titer antibodies occur in recently COVID-19-vaccinated healthy individuals.We used the Ella platform to customize an automated ELISA for anti-contactin-1, -neurofascin-155, and -Caspr-1 serum IgG. Patients with known AN (23 anti-neurofascin, 13 anti-contactin-1, and 8 anti-Caspr-1), 64 patients with seronegative (sub) acute inflammatory neuropathies, and 30 healthy controls served for validation, including quality analysis versus standard ELISA. Thirty-seven diagnostic samples of patients with suspected AN and 280 sera of healthcare workers included in the CoVacSer study, collected 3 weeks after COVID-19 vaccination or infection, were tested for anti-contactin-1 and anti-neurofascin-155.The automated ELISA showed high sensitivity (87.5%-100%) and specificity (98.4%-100%) for identifying AN, with reduced hands-on time, high automation, and similar quality and titer characteristics as standard ELISA. Low-titer anti-neurofascin-155, but no anti-contactin-1 autoantibodies, were detected in 1/280 post-SARS-CoV-2-vaccination or infection sera (0.36%). Longitudinal testing and clinical assessment did not indicate SARS-CoV-2-related neurological symptoms.We provide a highly automated, rapid, universally applicable test platform for anti-(para)nodal antibodies. The low frequency of anti-(para)nodal antibodies and absence of clinical AN manifestations in COVID-19-vaccinated individuals support vaccination safety regarding AN development.

Keyword(s): Humans (MeSH) ; Autoantibodies: blood (MeSH) ; Enzyme-Linked Immunosorbent Assay: methods (MeSH) ; COVID-19: prevention & control (MeSH) ; COVID-19: immunology (MeSH) ; Female (MeSH) ; Male (MeSH) ; Middle Aged (MeSH) ; COVID-19 Vaccines: immunology (MeSH) ; Adult (MeSH) ; SARS-CoV-2 (MeSH) ; Ranvier's Nodes: immunology (MeSH) ; Contactin 1: immunology (MeSH) ; Aged (MeSH) ; Cell Adhesion Molecules: immunology (MeSH) ; Nerve Growth Factors: immunology (MeSH) ; Autoimmune Diseases of the Nervous System: immunology (MeSH) ; Autoimmune Diseases of the Nervous System: blood (MeSH) ; Autoimmune Diseases of the Nervous System: diagnosis (MeSH) ; COVID‐19 ; ELISA ; SARS‐CoV‐2 ; autoimmune nodopathy ; contactin‐1 ; neurofascin ; Autoantibodies ; COVID-19 Vaccines ; Contactin 1 ; Cell Adhesion Molecules ; NFASC protein, human ; Nerve Growth Factors ; CNTN1 protein, human


Contributing Institute(s):
  1. Berlin common (Berlin common)
Research Program(s):
  1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2026
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 Record created 2026-03-31, last modified 2026-04-17