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Sensitivity and Specificity of TSA-CBA for Autoantibodies Against Neural Antigen Determination

NCT05414890 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2022-06-10

No results posted yet for this study

Summary

Determination of autoantibodies against fragments derived from neurons, glia, and myelin sheath is instrumental in aiding diagnosis, differential diagnosis, as well as determining disease status of neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis (AE). Cell based assay (CBA) has been frequently recommended to detect autoantibodies of neuroantigens in the aforementioned neurological disorders. However, antibodies with low abundance or low affinity often fall beyond the threshold of CBA and pose significant challenges in practice. To this end, the investigators adopted a tyramide signal amplification (TSA) technology with the basis of CBA to improve sensitivity. The preliminary results suggest that this TSA-CBA platform is superior to conventional CBA in registered signals of the titer autoantibodies. In elevating the sensitivity, TSA-CBA also preserves antigen confirmation. This prospective study is launched to compare the sensitivity, specificity, clinical correlation between CBA and CBA-TSA, in determining autoantibodies against aquaporin 4 (AQP4-IgG), myelin oligodendrocyte glycoprotein (MOG-IgG), N-methyl-D-aspartate receptor (NMDAR-IgG) in a multicenter, double-blind setting.

Conditions

  • NMO Spectrum Disorder
  • NMDA-R Encephalitis
  • Diagnostic Self Evaluation
  • Immune System Diseases
  • Nervous System Diseases
  • Autoimmune Diseases of the Nervous System
  • Autoimmune Diseases

Interventions

DIAGNOSTIC_TEST

CBA-TSA

Compare the specificity, sensitivity, and clinical correlation between CBA and CBA-TSA, in detecting AQP4, MOG, and NMDAR IgG

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-01-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414890 on ClinicalTrials.gov