针对韦格纳肉芽肿和显微镜下多血管炎中抗蛋白酶3和髓过氧化物酶的抗中性粒细胞胞浆抗体的商业免疫测定的批判性评估。

A critical evaluation of commercial immunoassays for antineutrophil cytoplasmic antibodies directed against proteinase 3 and myeloperoxidase in Wegener's granulomatosis and microscopic polyangiitis.

作者信息

Csernok E, Ahlquist D, Ullrich S, Gross W L

机构信息

Department of Rheumatology, University of Lübeck and Rheumaklinik Bad Bramstedt, Germany.

出版信息

Rheumatology (Oxford). 2002 Nov;41(11):1313-7. doi: 10.1093/rheumatology/41.11.1313.

DOI:10.1093/rheumatology/41.11.1313

PMID:12422006

Abstract

OBJECTIVE

To evaluate the performance of 11 commercial enzyme-linked immunosorbent assay (ELISA) kits for the detection of antineutrophil cytoplasmic antibodies (ANCA) directed against proteinase 3 (PR3) and myeloperoxidase (MPO) in patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA).

METHODS

Serum samples were taken from 92 patients with a histological and clinical diagnosis of WG (n=50) or MPA (n=42) and from 30 disease controls (systemic lupus erythematosus, n=15; rheumatoid arthritis, n=15) and 30 healthy controls. Each of the sera was tested for the presence of ANCA directed against PR3 and MPO using 11 commercially available direct ELISA kits, our in-house PR3- and MPO-ANCA capture ELISAs, and the indirect immunofluorescence technique (IFT).

RESULTS

In tests for WG using PR3-ANCA, the commercial direct ELISA kits differed widely in their sensitivity (from 22 to 70%) and negative predictive value (NPV) (from 43 to 70%), but only moderately in their specificity (from 93 to 100%) and positive predictive value (PPV) (from 93 to 100%). The highest sensitivity (74%) and specificity (100%) for PR3-ANCA were obtained with the in-house capture ELISA. Similar differences and trends were noted for MPO-ANCA assays. Diagnostic sensitivity was more than 60% for four and at least 50% for six of the 11 ELISA kits. The PPV varied from 84 to 100% and the NPV from 58 to 70%. In tests for MPA, the MPO-ANCA ELISA kit designated F and the in-house capture ELISA were best (both had sensitivity 62% and specificity 100%). For both WG and MPA, maximum sensitivity for ANCA was obtained with IFT (80 and 70% respectively).

CONCLUSION

Determination of PR3-ANCA and MPO-ANCA with the commercial direct ELISA kits achieved poor sensitivity for both WG and MPA. The in-house PR3 and MPO-ANCA capture ELISAs performed better than the commercial ELISAs, combining higher specificity with similar sensitivity. IFT remains the best method for ANCA detection in both diseases.

摘要

目的

评估11种商用酶联免疫吸附测定（ELISA）试剂盒检测韦格纳肉芽肿（WG）和显微镜下多血管炎（MPA）患者中抗蛋白酶3（PR3）和髓过氧化物酶（MPO）的抗中性粒细胞胞浆抗体（ANCA）的性能。

方法

采集92例经组织学和临床诊断为WG（n = 50）或MPA（n = 42）的患者、30例疾病对照（系统性红斑狼疮，n = 15；类风湿关节炎，n = 15）以及30例健康对照的血清样本。使用11种市售直接ELISA试剂盒、我们内部的PR3和MPO - ANCA捕获ELISA以及间接免疫荧光技术（IFT）检测每份血清中抗PR3和MPO的ANCA。

结果

在使用PR3 - ANCA检测WG时，商用直接ELISA试剂盒在敏感性（从22%到70%）和阴性预测值（NPV）（从43%到70%）方面差异很大，但在特异性（从93%到100%）和阳性预测值（PPV）（从93%到100%）方面差异适中。内部捕获ELISA对PR3 - ANCA的敏感性最高（74%），特异性最高（100%）。MPO - ANCA检测也有类似的差异和趋势。11种ELISA试剂盒中有4种的诊断敏感性超过60%，6种至少为50%。PPV从84%到100%不等，NPV从58%到70%不等。在检测MPA时，指定为F的MPO - ANCA ELISA试剂盒和内部捕获ELISA表现最佳（敏感性均为62%，特异性均为100%）。对于WG和MPA，IFT检测ANCA的敏感性最高（分别为80%和70%）。