Comparative Analysis of BIOCHIP Mosaic-Based Indirect Immunofluorescence with Enzyme-Linked Immunosorbent Assay for Diagnosing Myasthenia Gravis

基于生物芯片嵌合体的间接免疫荧光法与酶联免疫吸附试验在重症肌无力诊断中的比较分析

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Abstract

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.

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