基于生物芯片镶嵌的间接免疫荧光法与酶联免疫吸附测定法诊断重症肌无力的对比分析
Comparative Analysis of BIOCHIP Mosaic-Based Indirect Immunofluorescence with Enzyme-Linked Immunosorbent Assay for Diagnosing Myasthenia Gravis.
作者信息
Gambino Caterina Maria, Agnello Luisa, Lo Sasso Bruna, Scazzone Concetta, Giglio Rosaria Vincenza, Candore Giuseppina, Ciaccio Anna Maria, Di Stefano Vincenzo, Brighina Filippo, Vidali Matteo, Ciaccio Marcello
机构信息
Clinical Molecular Medicine and Laboratory Medicine, Institute of Clinical Biochemistry, Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, 90127 Palermo, Italy.
Unit of Clinical Biochemistry, University of Palermo, 90127 Palermo, Italy.
出版信息
Diagnostics (Basel). 2021 Nov 13;11(11):2098. doi: 10.3390/diagnostics11112098.
BACKGROUND
The detection of anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibodies is useful in myasthenia gravis (MG) diagnosis and management. BIOCHIP mosaic-based indirect immunofluorescence is a novel analytical method, which employs the simultaneous detection of anti-AChR and anti-MuSK antibodies in a single miniature incubation field. In this study, we compare, for the first time, the BIOCHIP MG mosaic with conventional enzyme-linked immunosorbent assay (ELISA) in the diagnosis of MG.
METHODS
A total of 71 patients with MG diagnosis were included in the study. Anti-AChR and anti-MuSK antibodies were measured separately by two different ELISA and simultaneously by BIOCHIP. The results were then compared.
RESULTS
The overall concordance between ELISA and BIOCHIP for anti-AChR reactivity was 74%. Cohen's kappa was 0.51 (95% CI 0.32-0.71), which corresponds to 90% of the maximum possible kappa (0.57), given the observed marginal frequencies. The overall concordance for anti-MuSK reactivity was 84%. Cohen's kappa was 0.11 (95% CI 0.00-0.36), which corresponds to 41% of the maximum possible kappa (0.27).
CONCLUSION
The overall concordance among assays is not optimal.
背景
抗乙酰胆碱受体（AChR）和抗肌肉特异性酪氨酸激酶（MuSK）抗体的检测对重症肌无力（MG）的诊断和管理很有用。基于生物芯片镶嵌的间接免疫荧光是一种新型分析方法，它能在单个微型孵育区域同时检测抗AChR和抗MuSK抗体。在本研究中，我们首次在MG诊断中比较了生物芯片MG镶嵌法与传统酶联免疫吸附测定（ELISA）。
方法
本研究共纳入71例确诊为MG的患者。通过两种不同的ELISA分别检测抗AChR和抗MuSK抗体，并通过生物芯片同时检测。然后比较结果。
结果
ELISA与生物芯片在抗AChR反应性方面的总体一致性为74%。科恩kappa系数为0.51（95%可信区间0.32 - 0.71），鉴于观察到的边缘频率，这相当于最大可能kappa值（0.57）的90%。抗MuSK反应性的总体一致性为84%。科恩kappa系数为0.11（95%可信区间0.00 - 0.36），这相当于最大可能kappa值（0.27）的41%。
结论
各检测方法之间的总体一致性并不理想。
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