NCT05219097

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

Completed Last updated 19 January 2023

What this trial tests

trial testing CBA Assay in Detection Autoantibody of Myasthenia Gravis in 2,663 participants. Completed in 31 December 2022.

Timeline

1 January 2021

Primary endpoint
30 September 2022

31 December 2022

Quick facts

Lead sponsor	Tianjin Medical University General Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,663
Start date	1 January 2021
Primary completion	30 September 2022
Estimated completion	31 December 2022
Sites	2 locations across China

Drugs / interventions tested

• CBA Assay

Conditions studied

• Detection Autoantibody of Myasthenia Gravis — all drugs for Detection Autoantibody of Myasthenia Gravis →

Sponsor

Tianjin Medical University General Hospital

Who can join

Adults 1 to 90, any sex, with Detection Autoantibody of Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study.
   Li Z, Zhang C, Chang T, Zhang X, et al · · 2023 · cited 16× · PMID 37554174 · DOI 10.1016/j.lanwpc.2023.100846