Department of Internal Medicine, Rheumatology and Immunology, Vasculitis Center Tübingen-Kirchheim, University Hospital Kirchheim, Germany.
Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, The Netherlands.
Autoimmun Rev. 2016 Jul;15(7):736-41. doi: 10.1016/j.autrev.2016.03.010. Epub 2016 Mar 9.
The aim of this multicenter EUVAS study was to evaluate the diagnostic performance of multi-parametric indirect immunofluorescence (IIF) assays to detect anti-neutrophil cytoplasmic antibodies (ANCA) in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
The study included 912 samples from diseased controls and 249 diagnostic samples from GPA (n=183) and MPA (n=66) patients. The performance of two automated multi-parametric assays [Aklides (Medipan/Generic Assays) and EuroPattern (Euroimmun)] combining IIF on cellular and purified antigen substrates was compared with two manual IIF analyses and with commercially available ELISAs for MPO- and PR3-ANCA (Euroimmun).
The area under the curve (AUC) of the receiver operating characteristics (ROC) curve to discriminate AAV from controls was 0.925, 0.848, 0.855 and 0.904 for, respectively, the two manual analyses, Aklides and EuroPattern, and 0.959, 0.921 and 0.886 for, respectively, antigen-specific ELISA, antigen-coated beads, and microdot, respectively. Variation in pattern assignment between IIF methods was observed.
The performance of IIF depends on the substrate used and the definition of IIF patterns. The performance of automated IIF is improved by multi-parameter testing (combined IIF and antigen-specific testing). Given the variability between IIF methods, the diagnostic importance of this technique is questioned.
本 EUVAS 多中心研究旨在评估多参数间接免疫荧光（IIF）检测在肉芽肿性多血管炎（GPA）和显微镜下多血管炎（MPA）患者抗中性粒细胞胞浆抗体（ANCA）中的诊断性能。
该研究纳入了来自疾病对照组的 912 个样本和来自 GPA（n=183）和 MPA（n=66）患者的 249 个诊断样本。比较了两种自动化多参数检测方法[Aklides（Medipan/Generic Assays）和 EuroPattern（Euroimmun）]与两种手动 IIF 分析以及两种用于 MPO-和 PR3-ANCA 的商业 ELISA（Euroimmun）在细胞和纯化抗原底物上的 IIF 组合性能。
用于区分 AAV 与对照组的 ROC 曲线下面积（AUC）分别为两种手动分析、Aklides 和 EuroPattern 的 0.925、0.848、0.855 和 0.904，以及抗原特异性 ELISA、抗原包被珠和微点的 0.959、0.921 和 0.886。观察到 IIF 方法之间在图案分配上的差异。
IIF 的性能取决于所使用的底物和 IIF 图案的定义。通过多参数检测（联合 IIF 和抗原特异性检测）可提高自动 IIF 的性能。鉴于 IIF 方法之间的可变性，该技术的诊断重要性受到质疑。
