A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context
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. Meth...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Language: | English |
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Elsevier
2023-09-01
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| Series: | The Lancet Regional Health. Western Pacific |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666606523001645 |
| _version_ | 1797776650525474816 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Zhiguo Li |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T22:52:58Z |
| format | Article |
| id | doaj.art-5da668214ce7427f87472322c33f1285 |
| institution | Directory Open Access Journal |
| issn | 2666-6065 |
| language | English |
| last_indexed | 2024-03-12T22:52:58Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health. Western Pacific |
| spelling | doaj.art-5da668214ce7427f87472322c33f12852023-07-20T04:39:13ZengElsevierThe Lancet Regional Health. Western Pacific2666-60652023-09-0138100846A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in contextZhiguo Li0Chao Zhang1Ting Chang2Xinghu Zhang3Huan Yang4Feng Gao5Jinzhou Feng6Hongbo Liu7Sheng Chen8Lihua Wang9Chunsheng Yang10Huining Li11Yuesong Pan12Jacqueline Palace13Fu-Dong Shi14Fu-Dong ShiZhiguo LiChao ZhangChunsheng YangHuining LiMinshu LiPei ZhengNan YaoSiting WuXuelu DingGuoqiang ChangLi YangMoli FanXin LiuQiuyu Wang Chang Ruan Zhang Wang Tian Pan YangFeng GaoJie LvJinzhou FengHongbo LiuSheng ChenLihua WangXiaodan KongYu WangJacqueline PalaceDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Neurology, Tangdu Hospital, Air Force Medical University, Xi'an, Shanxi, ChinaCentre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Neuroimmunology, Henan Institute of Medical and Pharmaceutical Sciences, Academy of Medical Science, Zhengzhou University, Zhengzhou, ChinaDepartment of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Neurology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, ChinaDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, ChinaCentre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Neurology, John Radcliffe Hospital Oxford, Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UKDepartment of Neurology, Tianjin Medical University General Hospital, Tianjin, China; Centre for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Corresponding author. Department of Neurology, Institute of Neuroimmunology, Tianjin Medical University General Hospital, Tianjin, China.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.http://www.sciencedirect.com/science/article/pii/S2666606523001645Myasthenia gravisAutoantibody diagnostic assaysAnti-acetylcholine receptor antibodyAnti-muscle-specific kinase antibody |
| spellingShingle | 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 A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context The Lancet Regional Health. Western Pacific Myasthenia gravis Autoantibody diagnostic assays Anti-acetylcholine receptor antibody Anti-muscle-specific kinase antibody |
| title | A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context |
| title_full | A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context |
| title_fullStr | A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context |
| title_full_unstemmed | A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context |
| title_short | A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM studyResearch in context |
| title_sort | multicentre prospective double blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis the scream studyresearch in context |
| topic | Myasthenia gravis Autoantibody diagnostic assays Anti-acetylcholine receptor antibody Anti-muscle-specific kinase antibody |
| url | http://www.sciencedirect.com/science/article/pii/S2666606523001645 |
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