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A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context
oleh: Zhiguo Li, Chao Zhang, Ting Chang, Xinghu Zhang, Huan Yang, Feng Gao, Jinzhou Feng, Hongbo Liu, Sheng Chen, Lihua Wang, Chunsheng Yang, Huining Li, Yuesong Pan, Jacqueline Palace, Fu-Dong Shi, Fu-Dong Shi, Zhiguo Li, Chao Zhang, Chunsheng Yang, Huining Li, Minshu Li, Pei Zheng, Nan Yao, Siting Wu, Xuelu Ding, Guoqiang Chang, Li Yang, Moli Fan, Xin Liu, Qiuyu Wang, Chang, Ruan, Zhang, Wang, Tian, Pan, Yang, Feng Gao, Jie Lv, Jinzhou Feng, Hongbo Liu, Sheng Chen, Lihua Wang, Xiaodan Kong, Yu Wang, Jacqueline Palace
Format: | Article |
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Diterbitkan: | Elsevier 2023-09-01 |
Deskripsi
Summary: Background: Laboratory 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. 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.