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After MG suspected patients in each center matched up with the inclusion and exclusion criteria, each patient's serum was divided into 4 equal parts (500 ul/part), and were randomly assigned to the CBA, ELSIA and RIPA testing laboratories for detecting. Groups: The samples were divided into 4 groups according to the detected methods: CBA group, CBA-TSA group, RIPA group and ELISA group. The kit of AChR or MuSK IgG ELISA Kits was purchased by RSR Limited, UK or IBL Limited, Germany. The method of ELISA was performed by Tianjin Medical University General Hospital Neuroimmunology Laboratory. The kit of AChR or MuSK IgG RIPA was purchased by RSR Limited, UK. The method of RIPA was performed by Beijing North Biotechnology Co., Ltd. The kit of AChR or MuSK IgG CBA and CBA-TSA was purchased from Tianjin New Terrain Biological Technology Co., Ltd, China. The method of CBA and CBA-TSA antibody IgG detected was performed by Tianjin Jinyu Medical Laboratory Co., Ltd.
#The signal state igg trial
Trial Period: The trial recruiting duration is 5-6 months, and the entire study period is estimated to be about 8 months. At least 50 cases for each other centers, competitive recruited.Ä¢) Recruiting 200 people as normal controls that has already completed by the Beijing-Tianjin Center. The Beijing-Tianjin Center has already recruited 1,500 cases. Total cases: 1) Recruiting 3000 patients with suspected myasthenia gravis. Study design: Multicenter, double-blind, CBA/CBA-TSA, ELSIA and RIPA methodology comparison To verify the function of AChR subunits in detecting the AChR antibody IgG through CBA testing. Secondary aim: Analyzing the advantage of CBA-TSA assay when AChR or MuSK IgG in low abundance and low affinity. Primary aim: Comparison of the specificity, sensitivity and clinical correlation of CBA, CBA-TSA, RIPA and ELISA assay in detecting AChR and MuSK IgG of myasthenia gravis.
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Participants: The serum of myasthenia gravis patients. Condition or diseaseÄiagnostic Self Evaluation Myasthenia Gravis To this end, we propose to conduct a multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, CBA-TSA (Tyramide Signal Amplification), RIPA and ELISA assays. 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. At present, specificity and sensitivity of these methods have not been compared in large cohorts in the context of stringent quality control. Radioimmunoprecipitation assay (RIPA), enzyme-linked immunosorbent assay (ELISA) and cell-based assay (CBA) that are all commercially available, have been adopted for detection by most referring neurologists. In the guidelines for the diagnosis and treatment of myasthenia gravis in the United States or the United Kingdom, determination of AChR and MuSK antibodies has been recommended. Presence of autoantibody specific for AChR or MuSK can establish diagnosis in conjunction with clinical presentations. Myasthenia gravis (MG) is a neuromuscular junction (NMJ) transmission disorder mediated by autoantibodies against AChR, MuSK and other autoantigens located at the post synaptic membrane of neuromuscular junction.