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

Diagnostics (Basel). 2021 Nov 13;11(11):2098. doi: 10.3390/diagnostics11112098.

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.

Keywords: BIOCHIP; anti-acetylcholine receptor antibodies; anti-muscle-specific tyrosine kinase antibodies; biomarker; diagnosis; myasthenia gravis.