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The Specificity, Sensitivity and Clinical Correlation of CBA, RIPA and ELISA in Detecting AChR and MuSK IgG of Myasthenia Gravis

NCT05219097 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2663

Last updated 2023-01-19

No results posted yet for this study

Summary

Myasthenia gravis (MG) is a neuromuscular junction (NMJ) disorder mediated by autoantibodies against AChR, MuSK or other autoantigens located at the post synaptic membrane of the neuromuscular junction. Presence of autoantibodies specific for AChR or MuSK can establish diagnosis in conjunction with clinical presentations. In most established guidelines for the diagnosis and treatment of myasthenia gravis, determination of AChR and MuSK antibodies has been recommended. Radioimmunoprecipitation assay (RIPA), enzyme-linked immunosorbent assay (ELISA), and cell-based assay (CBA) are all commercially available and have been adopted for autoantibody detection by most referring neurologists. At present, specificity and sensitivity of these methods have not been compared in large cohorts within a context of stringent quality control. As a consequence, there are no national or international consensus regarding selection of methods and interpretation of results, resulting in challenges to neurologists managing these patients. To this end, the investigators proposed to conduct a multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA and ELISA assays to detect AChR and MuSK antibodies.

Conditions

  • Detection Autoantibody of Myasthenia Gravis

Interventions

DIAGNOSTIC_TEST

CBA Assay

Comparsion of specificity, sensitivity and clinical correlation of CBA, ELISA and RIPA assay in autoantibodies detection of myasthenia gravis

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    lead OTHER

Principal Investigators

  • Fu-Dong Shi, MD, Ph.D · Beijing Tiantan Hospital,Tianjin Medical University General Hospital

Eligibility

Min Age
1 Year
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • China

Study Locations

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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 NCT05219097 on ClinicalTrials.gov