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

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ClinicalTrials.gov Identifier: NCT05219097

Recruitment Status : Completed

First Posted : February 1, 2022

Last Update Posted : January 19, 2023

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Sponsor:

Information provided by (Responsible Party):

Fu-Dong Shi, Tianjin Medical University General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Detection Autoantibody of Myasthenia Gravis	Diagnostic Test: CBA Assay

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Detailed Description:

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.

2. Acetylcholine receptor autoantibody CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.

3. Acetylcholine receptor autoantibody ELISA kit: RSR limited; recommended cut-off value=0.45 nmol/L.

4. Muscle-specific tyrosine kinase RIA kit: RSR limited, recommended cut-off value =0.05 nmol/L.

5. Muscle-specific tyrosine kinase CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.

6. Muscle-specific tyrosine kinase ELISA kit: IBL, recommended cut-off value=0.4 U/ml.

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.

2. All patient's information will be masked and monitored by members of ethics committees. Serum specimens from participants will be renumbered without any clinical information before doing the tests to be investigated. According to the standard procedure of kits, the operator in laboratories to perform the CBA, ELISA, or RIPA will complete the detection of AChR and MuSK antibodies of the enrolled participants' serum, and record the original value, control, or reference value.

3. Each MG center will provide the clinical diagnosis results of the enrolled patients, treatment and follow up information of the participants. The diagnosis of MG and the tests to be investigated will be double blindly done.

4. The data statistics, analysis, and summary of the project are operated by an independent third-party statistic team.

Evaluation indicators: Evaluate the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.

Study Design

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Study Type :	Observational
Actual Enrollment :	2663 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Comparison of the Specificity, Sensitivity and Clinical Correlation of CBA, RIPA and ELISA Assay in Detecting AChR and MuSK IgG of Myasthenia Gravis: a National Multicenter Study
Actual Study Start Date :	January 1, 2021
Actual Primary Completion Date :	September 30, 2022
Actual Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Myasthenia gravis

MedlinePlus related topics: Allergy Myasthenia Gravis

Drug Information available for: Musks

Genetic and Rare Diseases Information Center resources: Myasthenia Gravis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cell Based Assay (CBA) 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 Comparsion of specificity, sensitivity and clinical correlation of CBA, ELISA and RIPA assay in autoantibodies detection of myasthenia gravis Other Names: ELISA Assay RIPA Assay
RIPA Assay Use AChR and MuSK Ab radioimmunoassay kit (RSR Limited, UK) 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 Other Names: ELISA Assay RIPA Assay
ELISA 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 Other Names: ELISA Assay RIPA Assay

Outcome Measures

Primary Outcome Measures :

Comparsion of the specificity, sensitivity and clinical correlation [ Time Frame: 24 months ]
Comparsion the specificity,sensitivity and clinical correlation of CBA, RIPA and ELISA assay in autoantibodies detection of myasthenia gravis

Biospecimen Retention: None Retained

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Eligibility Criteria

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Ages Eligible for Study:	1 Year to 90 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients with suspected MG, 1-90 years of age.

Criteria

Inclusion Criteria:

Patients with compatible clinical features of weakness of skeletal muscles, including ptosis, diplopia, dysphonia, dysphagia, or limb weakness.
Patients need to do the diagnosis of MG, requiring serum autoantibody, electrophysiological, pharmacological neostigmine test, thymic computed tomography (CT) and magnetic resonance imaging (MRI), etc in the diagnostic evaluation of MG.

Exclusion Criteria:

Patients with uncertain diagnoses or incomplete clinical data for data analysis.
Patients with abnormal serum samples, such as hemolysis or lipemia, which will affect the detection base value and the final interpretation of CBA, RIPA and ELISA.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219097

Locations

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China
Beijing Tiantan Hospital
Beijing, China, 100070
Tianjin Medical University General Hospital
Tianjin, China, 30000

Sponsors and Collaborators

Tianjin Medical University General Hospital

Investigators

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Study Chair:	Fu-Dong Shi, MD, Ph.D	Beijing Tiantan Hospital,Tianjin Medical University General Hospital

More Information

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Responsible Party:	Fu-Dong Shi, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:	NCT05219097
Other Study ID Numbers:	IRB2021-YX-260-01
First Posted:	February 1, 2022 Key Record Dates
Last Update Posted:	January 19, 2023
Last Verified:	January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Fu-Dong Shi, Tianjin Medical University General Hospital:


Cell-based assay Radioimmunoprecipitation assay (RIPA) Enzyme-linked immunosorbent assay (ELISA) Autoantibody determination Myasthenia gravis

Additional relevant MeSH terms:

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Myasthenia Gravis Muscle Weakness Immune System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System	Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases

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