Clinical Neurobiology Unit, Regional Referring Multiple Sclerosis Centre, University Hospital San Luigi Gonzaga, Orbassano, Turin, Italy.
PLoS One. 2012;7(6):e38896. doi: 10.1371/journal.pone.0038896. Epub 2012 Jun 12.
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).
In this study, we evaluated a new multiparametric indirect immunofluorescence (IIF) assay for NMO serology.
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).
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.
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.
视神经脊髓炎（NMO）是一种严重的中枢神经系统自身免疫性疾病，主要影响视神经和脊髓。在大多数情况下，NMO 与抗水通道蛋白-4（AQP4）的抗体（称为 NMO-IgG）相关。
本研究评估了一种新的多参数间接免疫荧光（IIF）检测用于 NMO 血清学的方法。
使用商业复合免疫荧光检测试剂盒（“神经科马赛克 17”；Euroimmun，德国），对 20 名 NMO 患者、41 名多发性硬化症（MS）患者、30 名健康对照者和一种商业 AQP4 特异性 IgG 抗体进行检测。该试剂盒由五种不同的诊断底物组成（转染 AQP4 的 HEK 细胞、未转染的 HEK 细胞、灵长类小脑、大脑和视神经组织切片）。
我们确定了 AQP4 特异性和非特异性荧光染色模式，并建立了阳性标准。基于这些标准，该试剂盒对 NMO 具有高灵敏度（95%）和特异性（100%），且阳性和阴性似然比（LR+ = ∞，LR- = 0.05）显著。此外，还发现了该试剂盒具有良好的实验室间和实验室内重复性。
本研究中测试的生物芯片马赛克检测试剂盒是一种用于 NMO 血清学的强大工具，操作快速，对 NMO 具有高灵敏度和特异性，重复性好，适合进行实验室间标准化，满足多中心临床试验的要求。
