中华临床免疫和变态反应杂志2017，Vol.11Issue(2)：112-118,7.DOI:10.3969/j.issn.1673-8705.2017.02.003
化学发光法检测抗髓过氧化物酶抗体和抗蛋白酶3抗体
Chemiluminescent Immunoassay for the Detection of Anti-myeloperoxidaseand Anti-proteinase 3 Autoantibodies
摘要
Abstract
Objective To evaluate the clinical performance of an automated, quantitative and random-accessed Chemiluminescent Immunoassay (CLIA) for testing anti-MPO and anti-PR3 autoantibodies.Methods A total of 242 clinical serum samples were screened by immunofluorescence assay (IFA) for anti-neutrophil autoantibody (ANCA) and then tested with CLIA and enzyme-linked immunosorbent assay (ELISA) for anti-MPO and anti-PR3 autoantibodies in parallel.Results CLIA and ELISA showed excellent agreement for anti-MPO.The overall agreement, negative agreement, and positive agreement were 93.8%, 98.8%, and 81.9% respectively.Receiver operating characteristics (ROC) analysis showed that area under the curve (AUC) was 0.966 for anti-MPO.While a relatively poor agreement between CLIA and ELISA for anti-PR3 was found.The overall agreement, negative agreement, and positive agreement were 86.8%, 96.1%, and 35.1%.Receiver operating characteristics (ROC) analysis showed that the AUC was 0.839 for anti-PR3.All CLIA and ELISA discrepant samples for anti-PR3 were retested with the reagents from other manufacturer (the validation reagent).No significant difference was observed between CLIA and the validation reagent.But a significant difference was detected in the test results between ELISA and the validation reagents.The positive, negative and total agreement between CLIA and IFA were 60.8%, 94.8%, and 79.8%, while the positive, negative, and total agreement between ELISA and IFA were 73.6%, 77.2% and 75.6%.Conclusions Excellent agreement can be found for anti-MPO but a relatively poor agreement for anti-PR3 between CLIA and ELISA has been found.The specificity of CLIA is superior to ELISA for both anti-MPO and anti-PR3.We recommend that careful verification and validation should be performed based on IFA screening test, clinical diagnosis and assay features before choosing a test method for anti-MPO and anti-PR3.关键词
化学发光法/抗髓过氧化物酶抗体/抗蛋白酶3抗体/抗中性粒细胞胞浆抗体/间接免疫荧光法/酶联免疫吸附法Key words
chemiluminescent immunoassay/anti-myeloperoxidase/anti-proteinase 3/immunofluorescent assay/enzyme-linked immunosorbent assay分类
医药卫生引用本文复制引用
马晋,张蜀澜,胡朝军,柳乐,李庆春,李梦涛,曾小峰..化学发光法检测抗髓过氧化物酶抗体和抗蛋白酶3抗体[J].中华临床免疫和变态反应杂志,2017,11(2):112-118,7.基金项目
国家863计划重大项目(2011AA02A104),江苏省重大科技成果转化项目(BA2013038) （2011AA02A104）
