期刊
LANCET REGIONAL HEALTH-WESTERN PACIFIC
卷 38, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.lanwpc.2023.100846
关键词
Myasthenia gravis; Autoantibody diagnostic assays; Anti-acetylcholine receptor antibody; Anti-muscle-specific kinase antibody
This prospective multicenter cohort study evaluated the diagnostic accuracy of cell-based assay (CBA), radioimmunoprecipitation assay (RIPA), and enzyme-linked immunosorbent assay (ELISA) in detecting AChR and MuSK autoantibodies for the diagnosis of myasthenia gravis (MG).
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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