An observational study in Detection Autoantibody of Myasthenia Gravis, sponsored by Tianjin Medical University General Hospital. Completed at 2 sites in China. Open to participants aged 1 Year to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Tianjin Medical University General Hospital · Observational
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.
Participants: patients with suspected MG
Aim: the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
Study design: A multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA, and ELISA assays in detecting AChR and MuSK antibodies.
Total enrollment: 3000 patients with suspected MG will be enrolled.
Time frame: The enrollment time of this trial is 21 months, and the entire study period is about 24 months.
Reagent resource: 1. Acetylcholine receptor autoantibody RIA kit: RSR limited, recommended cut-off value=0.5 nmol/L.
Groups: The samples were divided into 3 groups according to the detected methods: CBA group, RIPA group and ELISA group.
Study protocol: 1. When patients suspected of MG matched up with the inclusion and exclusion criteria, the serum sample of each patient would be divided into equal aliquots and randomly assigned to the CBA, ELISA, and RIPA testing laboratories for detection.
Evaluation indicators: Evaluate the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's enrollment of 2,663 is above the median of 140 across 104 observational studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Tianjin Medical University General Hospital is the lead sponsor of 71 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with suspected MG, 1-90 years of age.
Exclusion Criteria:
Use AChR/MuSK Ab CBA Kit (Tianjin New Terrain Biological Technology Co., Ltd, China) to detect AChR and MuSK Ab of myasthenia gravis
Diagnostic Test: CBA Assay
Use AChR and MuSK Ab radioimmunoassay kit (RSR Limited, UK) to detect AChR and MuSK Ab of myasthenia gravis
Diagnostic Test: CBA Assay
Use AChR Ab ELISA Kit (RSR Limited, UK) and MuSK ELISA kit (IBL Limited, Germany) to detect AChR and MuSK Ab of myasthenia gravis
Diagnostic Test: CBA Assay
Comparsion of specificity, sensitivity and clinical correlation of CBA, ELISA and RIPA assay in autoantibodies detection of myasthenia gravis
Also known as: ELISA Assay, RIPA Assay
Comparsion of the specificity, sensitivity and clinical correlation
Comparsion the specificity,sensitivity and clinical correlation of CBA, RIPA and ELISA assay in autoantibodies detection of myasthenia gravis
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tianjin Medical University General Hospital