全自动流式点阵免疫发光法测定抗MPO和抗PR3抗体的性能评估  

Performance Evaluation of Anti-MPO and Anti-PR3 Antibodies by Automatic Multiplexed Bead Immunoassay

作　　者：殷波涛 汪峰 吴士及 Yin Botao;Wang Feng;Wu Shijin(Department of Laboratory,Tongji Hospital,Tongji Medical Colleg,Huazhong University of Science and Technology,Wuhan 430030,Chin)

机构地区：[1]华中科技大学同济医学院附属同济医院检验科,武汉430030

出　　处：《华中科技大学学报（医学版）》2018年第4期455-459,共5页Acta Medicinae Universitatis Scientiae et Technologiae Huazhong

基　　金：国家自然科学基金资助项目(No.81401639)

摘　　要：目的评估全自动流式点阵免疫发光法(MBIA法)测定抗髓过氧化物酶(MPO)和抗蛋白酶3(PR3)抗体的检测性能。方法按照美国临床实验室标准化委员会(CLIS)EP15-A3文件进行精密度验证,按照EP28-A3文件验证参考区间。比较MBIA法和ELISA法检测抗PR3和抗MPO结果,结合间接免疫荧光法(IFT)评价不同方法对抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)的诊断效能。结果 MBIA法检测抗PR3和MPO抗体批内、批间不精密度分别为3.65%、4.10%和2.28%、3.32%,小于厂家声明允许不精密度批内4.70%、批间8.60%,符合要求。MBIA和ELISA两种方法检测抗PR3和抗MPO的阳性、阴性、总符合率分别是40.00%、90.89%、90.72%和80.49%、97.65%、96.10%。MBIA法和ELISA法的敏感性、特异性以及阳性预测值分别是53.85%、91.69%、67.31%和55.38%、79.71%、46.45%。与IFT结果结合后,阳性预测值可分别提高至83.56%、73.48%。结论 MBIA法检测性能符合要求,其诊断AAV的效能要优于ELISA法,与IFT法结果结合可提高对AAV诊断的阳性预测值。Objective To evaluate the performance of MBIA assay in detecting anti-myeloperoxidase（MPO）and anti-protease 3（PR3）antibodies.Methods Precision validation was conducted in accordance with EP15-A3 document of clinical laboratory standardization commission（CLIS）,and the reference range was verified according to EP28-A3.Anti-PR3 and anti-MPO were detected by MBIA method and ELISA method,and the results were compared.Diagnostic efficiency of the two methods for ANCA associated vasculitis（AAV）was compared by indirect immunofluorescence method（IFT）.Results The with-run precision of anti-PR3 and anti-MPO detected by MBIA were 3.65%and 2.28%,between-day precision were 4.10%and 3.32%,respectively,smaller than the 4.70% and 8.60% declared by the manufacturer.The positive,negative and total coincidence rates of antiPR3 and anti-MPO detected by MBIA and ELISA were 40.00%,90.89%,90.72% and 80.49%,97.65% and 96.10%,respectively.The sensitivity,specificity and positive predictive values of MBIA and ELISA were 53.85%,91.69%,67.31%,55.38%,79.71% and 46.45%,respectively.Combined with the IFT results,the positive predictive value was elevated to 83.56% and73.48%for MBIA and ELISA,respectively.Conclusion The performance of MBIA method is better than that of ELISA,and combination with IFT can improve the positive predictive value of AAV diagnosis.

关 键 词：PR3 MPO ELISA 流式点阵发光免疫分析法 

分 类 号：R543[医药卫生—心血管疾病]