Journal
PLOS ONE
Volume 7, Issue 6, Pages -Publisher
PUBLIC LIBRARY SCIENCE
DOI: 10.1371/journal.pone.0038896
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Funding
- Alenia Areonautica S.p.A.
- FORB (Fondazione per la Ricerca Biomedica, ONLUS)
- Fondazione San Luigi ONLUS
- Czech Ministry of Education [MSM 0021620849]
- Grant Agency of Charles University [GAUK 132010]
- Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
- Bayer Vital
- Merck Serono
- Alenia Aeronautica Spa
- Euroimmun, Luebeck, Germany
- Biogen Idec
- Novartis
- Roche
- Bayer Schering
- Sanofi-Aventis
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Background: Neuromyelitis optica (NMO) is a severely disabling autoimmune disorder of the central nervous system, which predominantly affects the optic nerves and spinal cord. In a majority of cases, NMO is associated with antibodies to aquaporin-4 (AQP4) (termed NMO-IgG). Aims: In this study, we evaluated a new multiparametric indirect immunofluorescence (IIF) assay for NMO serology. Methods: Sera from 20 patients with NMO, 41 patients with multiple sclerosis (MS), 30 healthy subjects, and a commercial anti-AQP4 IgG antibody were tested in a commercial composite immunofluorescence assay (Neurology Mosaic 17; Euroimmun, Germany), consisting of five different diagnostic substrates (HEK cells transfected with AQP4, non-transfected HEK cells, primate cerebellum, cerebrum, and optic nerve tissue sections). Results: We identified AQP4 specific and non-specific fluorescence staining patterns and established positivity criteria. Based on these criteria, this kit yielded a high sensitivity (95%) and specificity (100%) for NMO and had a significant positive and negative likelihood ratio (LR+=infinity, LR-=0.05). Moreover, a 100% inter- and intra-laboratory reproducibility was found. Conclusions: The biochip mosaic assay tested in this study is a powerful tool for NMO serology, fast to perform, highly sensitive and specific for NMO, reproducible, and suitable for inter-laboratory standardization as required for multi-centre clinical trials.
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