Lim L C, Taylor J G, Schmitz J L, Folds J D, Wilkman A S, Falk R J, Jennette J C
William W. McLendon Clinical Laboratories, Clinical Immunology Laboratory, University of North Carolina Hospitals, Chapel Hill, USA.
Am J Clin Pathol. 1999 Mar;111(3):363-9. doi: 10.1093/ajcp/111.3.363.
Antineutrophil cytoplasmic autoantibodies (ANCAs) are increasingly used as serologic markers for pauci-immune crescentic glomerulonephritis and small vessel vasculitis. Many hospital laboratories and referral laboratories use commercial assay kits to detect ANCAs, despite inadequate documentation in the medical literature of kit performance. We evaluated the diagnostic sensitivity, specificity, and predictive value of 3 commercial indirect immunofluorescence assay (IFA) kits and 7 commercial enzyme immunoassay (EIA) kits for several ANCA subtypes. Serum samples from 396 patients with a variety of renal diseases were analyzed, including 146 patients with pauci-immune crescentic glomerulo-nephritis with or without systemic vasculitis. With 1 exception, the kits had more than 90% agreement with the reference standard and gave results similar to those of research laboratories. IFA diagnostic sensitivity ranged from 81% to 91% and EIA sensitivity from 75% to 84%. Maximum specificity was obtained with combined IFA and EIA. Diagnostic specificity was more than 70% for 2 of 3 IFA kits and at least 90% for 5 of 7 EIA kits. Predictive values varied with clinical manifestations. Most commercial IFA and EIA kits that were evaluated provide acceptably accurate analytic results.
抗中性粒细胞胞浆自身抗体（ANCA）越来越多地用作少免疫性新月体性肾小球肾炎和小血管炎的血清学标志物。尽管医学文献中关于试剂盒性能的记录不足，但许多医院实验室和转诊实验室仍使用商业检测试剂盒来检测ANCA。我们评估了3种商业间接免疫荧光法（IFA）试剂盒和7种商业酶免疫法（EIA）试剂盒对几种ANCA亚型的诊断敏感性、特异性和预测价值。分析了396例患有各种肾脏疾病的患者的血清样本，其中包括146例伴有或不伴有系统性血管炎的少免疫性新月体性肾小球肾炎患者。除1个试剂盒外，其余试剂盒与参考标准的一致性均超过90%，其结果与研究实验室的结果相似。IFA诊断敏感性范围为81%至91%，EIA敏感性范围为75%至84%。联合使用IFA和EIA可获得最高特异性。3种IFA试剂盒中的2种诊断特异性超过70%，7种EIA试剂盒中的5种诊断特异性至少为90%。预测值因临床表现而异。大多数经过评估的商业IFA和EIA试剂盒提供的分析结果准确性可接受。
