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

Granieri L, Marnetto F, Valentino P, Frau J, Patanella AK, Nytrova P, Sola P, Capobianco M, Jarius S, Bertolotto A.

Source: Clinical Neurobiology Unit, Regional Referring Multiple Sclerosis Centre, University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy

Abstract

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.

PMID: 22719979 [PubMed – indexed for MEDLINE]

PMCID: PMC3373605

PLoS One. 2012;7(6):e38896. doi: 10.1371/journal.pone.0038896. Epub 2012 Jun 12

Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3373605/

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