"A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study"

作者全名："Li, Zhiguo; Zhang, Chao; Chang, Ting; Zhang, Xinghu; Yang, Huan; Gao, Feng; Feng, Jinzhou; Liu, Hongbo; Chen, Sheng; Wang, Lihua; Yang, Chunsheng; Li, Huining; Pan, Yuesong; Palace, Jacqueline; Shi, Fu-Dong"

作者地址："[Li, Zhiguo; Zhang, Chao; Yang, Chunsheng; Li, Huining; Shi, Fu-Dong] Tianjin Med Univ Gen Hosp, Dept Neurol, Tianjin, Peoples R China; [Chang, Ting] Air Force Med Univ, Tangdu Hosp, Dept Neurol, Xian, Shaanxi, Peoples R China; [Zhang, Xinghu; Pan, Yuesong; Shi, Fu-Dong] Capital Med Univ, Beijing Tiantan Hosp, Ctr Neurol Dis, Beijing, Peoples R China; [Yang, Huan] Cent South Univ, Xiangya Hosp, Dept Neurol, Changsha, Peoples R China; [Gao, Feng] Zhengzhou Univ, Acad Med Sci, Henan Inst Med & Pharmaceut Sci, Dept Neuroimmunol, Zhengzhou, Peoples R China; [Feng, Jinzhou] Chongqing Med Univ, Affiliated Hosp 1, Dept Neurol, Chongqing, Peoples R China; [Liu, Hongbo] Zhengzhou Univ, Affiliated Hosp 1, Dept Neurol, Zhengzhou, Peoples R China; [Chen, Sheng] Shanghai Jiao Tong Univ, Shanghai Ruijin Hosp, Dept Neurol, Sch Med, Shanghai, Peoples R China; [Wang, Lihua] Harbin Med Univ, Affiliated Hosp 2, Dept Neurol, Harbin, Peoples R China; [Palace, Jacqueline; Shi, Fu-Dong] Univ Oxford, John Radcliffe Hosp Oxford, Dept Neurol, Nuffield Dept Clin Neurosci, Oxford, England"

通信作者："Shi, FD (通讯作者)，Tianjin Med Univ Gen Hosp, Inst Neuroimmunol, Dept Neurol, Tianjin, Peoples R China."

来源：LANCET REGIONAL HEALTH-WESTERN PACIFIC

ESI学科分类：　

WOS号：WOS:001061761400001

JCR分区：Q1

影响因子：7.6

年份：2023

卷号：38

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：Myasthenia gravis; Autoantibody diagnostic assays; Anti-acetylcholine receptor antibody; Anti-muscle-specific kinase antibody

摘要："Methods In 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. Findings 2272 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). Interpretation CBA has a higher diagnostic accuracy compared to RIPA or ELISA in detecting AChR and MuSK autoantibodies for MG diagnosis. Funding New Terrain Biotechnology, Inc., Tianjin, China. Copyright <(c)> 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)."

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