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Published on: April 5, 2019
Comparative Analysis of BIOCHIP Mosaic-Based Indirect Immunofluorescence with Enzyme-Linked Immunosorbent Assay for
Caterina Maria Gambino1, Luisa Agnello1, Bruna Lo Sasso1
1Clinical Molecular Medicine and Laboratory Medicine, Institute of Clinical Biochemistry, Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, 90127 Palermo, Italy.
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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