PMID- 37554174 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230810 IS - 2666-6065 (Electronic) IS - 2666-6065 (Linking) VI - 38 DP - 2023 Sep TI - A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study. PG - 100846 LID - 10.1016/j.lanwpc.2023.100846 [doi] LID - 100846 AB - 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. CI - (c) 2023 The Author(s). FAU - Li, Zhiguo AU - Li Z AD - Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China. FAU - Zhang, Chao AU - Zhang C AD - Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China. FAU - Chang, Ting AU - Chang T AD - Department of Neurology, Tangdu Hospital, Air Force Medical University, Xi'an, Shanxi, China. FAU - Zhang, Xinghu AU - Zhang X AD - Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. FAU - Yang, Huan AU - Yang H AD - Department of Neurology, Xiangya Hospital, Central South University, Changsha, China. FAU - Gao, Feng AU - Gao F AD - Department of Neuroimmunology, Henan Institute of Medical and Pharmaceutical Sciences, Academy of Medical Science, Zhengzhou University, Zhengzhou, China. FAU - Feng, Jinzhou AU - Feng J AD - Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. FAU - Liu, Hongbo AU - Liu H AD - Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. FAU - Chen, Sheng AU - Chen S AD - Department of Neurology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Wang, Lihua AU - Wang L AD - Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Yang, Chunsheng AU - Yang C AD - Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China. FAU - Li, Huining AU - Li H AD - Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China. FAU - Pan, Yuesong AU - Pan Y AD - Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. FAU - Palace, Jacqueline AU - Palace J AD - Department of Neurology, John Radcliffe Hospital Oxford, Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK. FAU - Shi, Fu-Dong AU - Shi FD AD - Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China. AD - Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. CN - SCREAM Study Investigators LA - eng SI - ClinicalTrials.gov/NCT05219097 PT - Journal Article DEP - 20230719 PL - England TA - Lancet Reg Health West Pac JT - The Lancet regional health. Western Pacific JID - 101774968 PMC - PMC10404541 OTO - NOTNLM OT - Anti-acetylcholine receptor antibody OT - Anti-muscle-specific kinase antibody OT - Autoantibody diagnostic assays OT - Myasthenia gravis COIS- All authors declare no competing interests. FIR - Shi, Fu-Dong IR - Shi FD FIR - Li, Zhiguo IR - Li Z FIR - Zhang, Chao IR - Zhang C FIR - Yang, Chunsheng IR - Yang C FIR - Li, Huining IR - Li H FIR - Li, Minshu IR - Li M FIR - Zheng, Pei IR - Zheng P FIR - Yao, Nan IR - Yao N FIR - Wu, Siting IR - Wu S FIR - Ding, Xuelu IR - Ding X FIR - Chang, Guoqiang IR - Chang G FIR - Yang, Li IR - Yang L FIR - Fan, Moli IR - Fan M FIR - Liu, Xin IR - Liu X FIR - Wang, Qiuyu IR - Wang Q FIR - Chang IR - Chang FIR - Ruan IR - Ruan FIR - Zhang IR - Zhang FIR - Wang IR - Wang FIR - Tian IR - Tian FIR - Pan IR - Pan FIR - Yang IR - Yang FIR - Gao, Feng IR - Gao F FIR - Lv, Jie IR - Lv J FIR - Feng, Jinzhou IR - Feng J FIR - Liu, Hongbo IR - Liu H FIR - Chen, Sheng IR - Chen S FIR - Wang, Lihua IR - Wang L FIR - Kong, Xiaodan IR - Kong X FIR - Wang, Yu IR - Wang Y FIR - Palace, Jacqueline IR - Palace J EDAT- 2023/08/09 06:43 MHDA- 2023/08/09 06:44 PMCR- 2023/07/19 CRDT- 2023/08/09 03:55 PHST- 2023/04/03 00:00 [received] PHST- 2023/06/20 00:00 [revised] PHST- 2023/06/27 00:00 [accepted] PHST- 2023/08/09 06:44 [medline] PHST- 2023/08/09 06:43 [pubmed] PHST- 2023/08/09 03:55 [entrez] PHST- 2023/07/19 00:00 [pmc-release] AID - S2666-6065(23)00164-5 [pii] AID - 100846 [pii] AID - 10.1016/j.lanwpc.2023.100846 [doi] PST - epublish SO - Lancet Reg Health West Pac. 2023 Jul 19;38:100846. doi: 10.1016/j.lanwpc.2023.100846. eCollection 2023 Sep.