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

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 th...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10404541/
https://www.ncbi.nlm.nih.gov/pubmed/37554174
http://dx.doi.org/10.1016/j.lanwpc.2023.100846
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author 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
author_facet 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
author_sort Li, Zhiguo
collection PubMed
description 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.
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spelling pubmed-104045412023-08-08 A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study 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 Lancet Reg Health West Pac Articles 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. Elsevier 2023-07-19 /pmc/articles/PMC10404541/ /pubmed/37554174 http://dx.doi.org/10.1016/j.lanwpc.2023.100846 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Articles
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
A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title_full A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title_fullStr A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title_full_unstemmed A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title_short A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study
title_sort multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the scream study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10404541/
https://www.ncbi.nlm.nih.gov/pubmed/37554174
http://dx.doi.org/10.1016/j.lanwpc.2023.100846
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