The Lancet Regional Health. Western Pacific (Sep 2023)

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

  • 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

Journal volume & issue
Vol. 38
p. 100846

Abstract

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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.

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