Segelmark Mårten, Phillips Brian D, Hogan Susan L, Falk Ronald J, Jennette J Charles
Department of Nephrology, Lund University, Lund, Sweden.
Clin Diagn Lab Immunol. 2003 Sep;10(5):769-74. doi: 10.1128/cdli.10.5.769-774.2003.
The clinical usefulness of antineutrophil cytoplasmic antibodies (ANCAs) in the monitoring of patients treated for small vessel vasculitis is debated. A capture enzyme-linked immunosorbent assay (ELISA) based on anti-proteinase 3 (anti-PR3) monoclonal antibody 4A3 has previously been proven to be superior to indirect immunofluorescence (IIF) and standard ELISA for the diagnosis of vasculitis. The present study compared the effectiveness of the capture ELISA for the detection of disease relapse. Samples from patients with relapses and remissions (relapse and remission samples, respectively) were identified through the database of the Glomerular Disease Collaborate Network. Twenty-one relapse samples and 49 remission samples were analyzed by the capture PR3-ANCA ELISA from Wieslab AB, the standard PR3-ANCA ELISA from Inova, and IIF. A Medline search was performed to identify published data on ANCA status at relapse. The capture ELISA was positive for 21 instances of relapses in 14 patients, while the standard ELISA and IIF each failed to detect 2 relapses (P was not significant). By using a higher cutoff value, the capture ELISA correctly categorized 84% of the remission samples and 81% of the relapse samples. Similar degrees of discrimination could be achieved by IIF but not by the standard ELISA. In previously published series, the median proportions of patients positive at relapse were 100% by IIF (range, 75 to 100%) and 86% by standard ELISA (range, 38 to 100%). The corresponding values for a rise that accompanied or preceded a relapse were 75% (range, 20 to 100%) for IIF and 50% (range, 25 to 81%) for ELISA. The capture PR3-ANCA ELISA is a sensitive tool for the detection of relapses. Larger studies are needed to detect differences between methods. Negative results by tests for ANCAs are rare during relapses.
抗中性粒细胞胞浆抗体(ANCA)在监测接受小血管炎治疗的患者中的临床实用性存在争议。基于抗蛋白酶3(抗PR3)单克隆抗体4A3的捕获酶联免疫吸附测定(ELISA)先前已被证明在血管炎诊断方面优于间接免疫荧光法(IIF)和标准ELISA。本研究比较了捕获ELISA检测疾病复发的有效性。通过肾小球疾病协作网络数据库识别复发和缓解患者的样本(分别为复发样本和缓解样本)。采用来自Wieslab AB的捕获PR3-ANCA ELISA、来自Inova的标准PR3-ANCA ELISA和IIF对21份复发样本和49份缓解样本进行分析。进行了Medline检索以确定关于复发时ANCA状态的已发表数据。捕获ELISA在14例患者的21次复发中呈阳性,而标准ELISA和IIF均未能检测到2次复发(P无显著性差异)。通过使用更高的临界值,捕获ELISA正确分类了84%的缓解样本和81%的复发样本。IIF可实现类似程度的区分,但标准ELISA不能。在先前发表的系列研究中,复发时阳性患者的中位比例通过IIF为100%(范围75%至100%),通过标准ELISA为86%(范围38%至100%)。复发伴随或之前出现升高时的相应值,IIF为75%(范围20%至100%),ELISA为50%(范围25%至81%)。捕获PR3-ANCA ELISA是检测复发的敏感工具。需要更大规模的研究来检测不同方法之间的差异。复发期间ANCA检测结果为阴性的情况很少见。