重症肌无力
自身抗体
医学
内科学
抗体
前瞻性队列研究
胃肠病学
队列
免疫学
作者
Zhiguo Li,Chao Zhang,Ting Chang,Xinghu Zhang,Huan Yang,Feng Gao,Jinzhou Feng,Hongbo Liu,Sheng Chen,Lihua Wang,Chun-Sheng Yang,Huining Li,Yuesong Pan,Jacqueline Palace,Fu‐Dong Shi,Fu‐Dong Shi,Zhiguo Li,Chao Zhang,Chun-Sheng Yang,Huining Li,Minshu Li,Pei Zheng,Nan Yang,Shao-Yi Wu,Xuelu Ding,Guoqiang Chang,Li Yang,Moli Fan,Xin Liu,Qiuyu Wang,Tsung-Hui Chang,Ruan,Haixia Zhang,Jiandong Wang,Ye Tian,Yongxin Pan,Jinfu Yang,Feng Gao,Jie Lü,Jinzhou Feng,Hongbo Liu,Sheng Chen,Lihua Wang,Xiaodan Kong,Yu Wang,Jacqueline Palace
标识
DOI:10.1016/j.lanwpc.2023.100846
摘要
BackgroundLaboratory determination of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK) and other autoantigens have been integrated into the diagnosis of myasthenia gravis (MG). However, evidence supporting the selection of methodologies is lacking.MethodsIn this prospective, multicentre cohort study, we recruited patients with suspected MG to evaluate the diagnostic accuracy of cell-based assay (CBA), radioimmunoprecipitation assay (RIPA) and enzyme-linked immunosorbent assay (ELISA) in detecting AChR and MuSK autoantibodies. This study is registered with www.clinicaltrials.gov, number NCT05219097.Findings2272 eligible participants were recruited, including 2043 MG, 229 non-MG subjects. AChR antibodies were detected in 1478, 1310, and 1280 out of a total of 2043 MG patients by CBA, RIPA, and ELISA, respectively; sensitivity, 72.3% (95% CI, 70.3–74.3), 64.1% (95% CI, 62.0–66.2), 62.7% (95% CI, 60.5–64.8); specificity, 97.8% (95% CI, 95.0–99.3), 97.8% (95% CI, 95.0–99.3), 94.8% (95% CI, 91.9–97.7). MuSK antibodies were found in 59, 50, and 54 from 2043 MG patients by CBA, RIPA and ELISA, respectively; sensitivity, 2.9% (95% CI, 2.2–3.7), 2.4% (95% CI, 1.8–3.2), 2.6% (95% CI, 2.0–3.4); specificity, 100% (95% CI, 98.4–100), 100% (95% CI, 98.4–100), and 99.1% (95% CI, 96.9–99.9). The area under the curve of AChR antibodies tested by CBA was 0.858, and there were statistical differences with RIPA (0.843; p = 0.03) and ELISA (0.809; p < 0.0001).InterpretationCBA has a higher diagnostic accuracy compared to RIPA or ELISA in detecting AChR and MuSK autoantibodies for MG diagnosis.FundingNew Terrain Biotechnology, Inc., Tianjin, China.