抗中性粒细胞胞浆抗体标准化检测在特发性系统性血管炎中的诊断价值。抗中性粒细胞胞浆抗体检测标准化的欧洲共同体/英国关节炎研究运动项目。
Diagnostic value of standardized assays for anti-neutrophil cytoplasmic antibodies in idiopathic systemic vasculitis. EC/BCR Project for ANCA Assay Standardization.
作者信息
Hagen E C, Daha M R, Hermans J, Andrassy K, Csernok E, Gaskin G, Lesavre P, Lüdemann J, Rasmussen N, Sinico R A, Wiik A, van der Woude F J
机构信息
Department of Nephrology, University Hospital Leiden, The Netherlands.
出版信息
Kidney Int. 1998 Mar;53(3):743-53. doi: 10.1046/j.1523-1755.1998.00807.x.
Anti-neutrophil cytoplasmic antibodies (ANCA) are widely used as diagnostic markers for Wegener's granulomatosis (WG), microscopic polyangiitis (MPA), Churg-Strauss syndrome (CSS) and idiopathic rapidly progressive glomerulonephritis (iRPGN). The objective of this study was to evaluate the diagnostic value of ANCA measurement by the indirect immunofluorescence (IIF) test, and by anti-PR3 and anti-MPO ELISA performed in different locations, in patients with idiopathic small vessel vasculitis. Fourteen centers participated in a standardization study of ANCA assays, and entered a total number of 169 newly diagnosed and 189 historical patients with idiopathic systemic vasculitis or iRPGN. Patients were classified according to a pre-defined diagnostic classification system. Results were compared with those of 184 disease controls and 740 healthy controls. The IIF test was performed according to standard methodology; ELISAs had been standardized among the participants in a previous phase of the study. The sensitivities of assays in patients were as follows. The sensitivity in WG was: cANCA 64%, pANCA 21%, anti-PR3 66%, anti-MPO 24%. In MPA the sensitivity was: cANCA 23%, pANCA 58%, anti-PR3 26%, anti-MPO 58%. Sensitivity in iRPGN was: cANCA 36%, pANCA 45%, anti-PR3 50%, anti-MPO 64%. The specificity of assays (related to disease controls) was: cANCA 95%, pANCA 81%, anti-PR3 87%, anti-MPO 91%. When the results of the IIF test were combined with those of the ELISAs (cANCA/anti-PR3 positive, pANCA/anti-MPO positive), the diagnostic specificity increased to 99%. The sensitivity of the combination of cANCA + anti-PR3 or pANCA + anti-MPO for WG, MPA or iRPGN was 73%, 67% and 82%, respectively. From this study we conclude that the value of the IIF test for ANCA detection can be greatly increased by the addition of a well standardized antigen-specific ELISA. In a significant number of patients with idiopathic small vessel vasculitis, however, the ANCA test results (either in IIF or ELISA) are negative.
抗中性粒细胞胞浆抗体（ANCA）被广泛用作韦格纳肉芽肿（WG）、显微镜下多血管炎（MPA）、变应性肉芽肿性血管炎（CSS）和特发性快速进展性肾小球肾炎（iRPGN）的诊断标志物。本研究的目的是评估在不同地点进行的间接免疫荧光（IIF）试验以及抗蛋白酶3（PR3）和抗髓过氧化物酶（MPO）酶联免疫吸附测定（ELISA）检测ANCA对特发性小血管炎患者的诊断价值。14个中心参与了ANCA检测的标准化研究，共纳入169例新诊断的和189例既往诊断的特发性系统性血管炎或iRPGN患者。根据预先定义的诊断分类系统对患者进行分类。将结果与184例疾病对照者和740例健康对照者的结果进行比较。IIF试验按照标准方法进行；ELISA在该研究的前一阶段已在参与者之间进行了标准化。各检测方法在患者中的敏感性如下。WG中的敏感性为：胞浆型ANCA（cANCA）64%，核周型ANCA（pANCA）21%，抗PR3 66%，抗MPO 24%。MPA中的敏感性为：cANCA 23%，pANCA 58%，抗PR3 26%，抗MPO 58%。iRPGN中的敏感性为：cANCA 36%，pANCA 45%，抗PR3 50%，抗MPO 64%。各检测方法（与疾病对照者相关）的特异性为：cANCA 95%，pANCA 81%，抗PR3 87%，抗MPO 91%。当将IIF试验结果与ELISA结果（cANCA/抗PR3阳性，pANCA/抗MPO阳性）相结合时，诊断特异性提高到99%。cANCA + 抗PR3或pANCA + 抗MPO联合检测对WG、MPA或iRPGN的敏感性分别为73%、67%和82%。从本研究我们得出结论，通过添加标准化良好的抗原特异性ELISA可大大提高IIF试验检测ANCA的价值。然而，在相当数量的特发性小血管炎患者中，ANCA检测结果（无论是IIF还是ELISA）均为阴性。
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