Evaluation of a multiparametric immunofluorescence assay for standardization of neuromyelitis optica serology

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 eval...

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Hauptverfasser: Granieri, Letizia (VerfasserIn) , Jarius, Sven (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: June 12, 2012
In: PLOS ONE
Year: 2012, Jahrgang: 7, Heft: 6
ISSN:1932-6203
DOI:10.1371/journal.pone.0038896
Online-Zugang:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1371/journal.pone.0038896
Verlag, kostenfrei, Volltext: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0038896
Volltext
Verfasserangaben:Letizia Granieri, Fabiana Marnetto, Paola Valentino, Jessica Frau, Agata Katia Patanella, Petra Nytrova, Patrizia Sola, Marco Capobianco, Sven Jarius, Antonio Bertolotto

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520 |a 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+ = ∞, 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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