两种系统检测血清IgG4结果一致性研究  

A Consistency Study of Two Systematic Detection of Serum IgG4 Results

作　　者：夏雨鑫 嵇金陵 杨艳艳 靳德甫 谢军 潘胜男 叶耘峰 姜玉章[1] XIA Yuxin;JI Jinling;YANG Yanyan;JIN Defu;XIE Jun;PAN Shengnan;YE Yunfeng;JIANG Yuzhang(Department of Clinical Laboratory,The First Affiliated Hospital of Huaian,Nanjing Medical University,Huaian 223300,China;Department of Clinical Laboratory,Sihong Fen Jinting Hospital,Suqian 223900,Jiangsu,China;Laboratory Department of Xuyi County People’s Hospital,Huaian 211700,Jiangsu,China;Jiangsu Nursing Vocational College,Huai’an 223300,China)

机构地区：[1]南京医科大学附属淮安第一医院检验科,江苏淮安223300 [2]泗洪分金亭医院检验科,江苏宿迁223900 [3]盱眙县人民医院检验科,江苏淮安211700 [4]江苏护理职业学院,江苏淮安223300

出　　处：《标记免疫分析与临床》2024年第3期545-549,共5页Labeled Immunoassays and Clinical Medicine

基　　金：淮安市创新服务能力建设计划-重点实验室建设项目(编号:HAP202004)。

摘　　要：目的IgG4相关性疾病(IgG4-RD)是一种少见的慢性炎症伴纤维化疾病,其临床表现缺乏特异性,易造成漏诊或误诊。评估西门子特定蛋白分析仪BNII(简称西门子)和贝克曼特定蛋白分析仪Immage800(简称贝克曼)检测IgG4结果的一致性,为IgG4相关疾病(IgG4-related disease,IgG4-RD)临床诊断与治疗提供精准的检测结果。方法收集2019年4月至2022年4月在南京医科大学附属淮安第一医院进行血清IgG4检测的患者血清标本127份。采用西门子BNII特定蛋白分析仪(配套试剂)作为参比系统,贝克曼Immage 800特定蛋白分析仪(配某国产试剂)为待评系统,分别检测127份血清标本,高浓度结果西门子系统仪器自动稀释,贝克曼系统手工稀释,比较两种方法检测结果的一致性,拟合Deming回归曲线。结果以西门子结果分组,IgG4水平在1.35~2.7g/L之间时,两系统检测结果间差异未见统计学意义(P=0.27),而IgG4结果在小于1.35、2.7~4.05g/L以及大于4.05g/L组间结果差异存在统计学意义(P<0.05)。127份标本中有10份IgG4异常高浓度结果标本在两系统间差异大,剔除后对剩余的117份标本进行Pearson相关性分析提示两种方法检测IgG4有良好的相关性(r=0.96,P<0.001),Bland-Altman分析两种方法检测的血清IgG4实测值一致性较好,拟合回归曲线为IgG4(贝克曼)=0.8597×IgG4(西门子)+0.1319。结论临床应用西门子仪器(配套试剂)和贝克曼仪器(配某国产试剂)检测血清IgG4时,对于≤4.05g/L的结果两台仪器一致性相对较好,但血清IgG4水平大于12.0g/L时,由于后带现象等因素,使用某国产试剂会使结果严重偏低引起假阴性,不利于疾病的动态评估,需引起临床重视。Objective IgG4-related disease(IgG4-RD)is a rare fibro-inflammatory disease,which is prone to missed diagnosis or mis-diagnosis due to non-specific clinical manifestations.In this study,we aim to evaluate the consistency of IgG4 results of Siemens specific protein analyzer BNII(referred to as Siemens)and Beckman specific protein analyzer Immage800(referred to as Beckman)to provide accurate test results for the clinical diagnosis and treatment of IgG4-related diseases(IgG4-RD).Methods From April,2019 to April,2022,127 serum samples were collected from patients who underwent serum IgG4 detection at The Affiliated Huai’an No.1 People’s Hospital of Nanjing Medical University.Siemens BN-II specific protein analyzer(supporting reagent)was used as the reference system,while Beckman Immage800 specific protein analyzer(with a domestic reagent)was used as the evaluation system.127 serum samples were detected respectively.The high concentration result was automatically diluted by Siemens system instruments,and Beckman system was manually diluted.We then compared the consistency of the detection results of the two methods and fit the Deming regression curve.Results Grouped by Siemens results,when the level of IgG4 was between 1.35-2.7g/L,there was no statistical difference between the detection results of the two systems(P=0.27),while the IgG4 results were lower than 1.35g/L,2.7-4.05g/L and greater than 4.05g/L.There were significant differences in the results(P<0.05).Among 127 serum samples,10 of the abnormally high concentration of IgG4 were very different between the two systems.After rejection,Pearson correlation analysis of the remaining 117 serum samples suggested that the two methods of detect IgG4 had a good correlation(r=0.96,P<0.001).The consistency of serum IgG4 detected by the two methods of blend-Altman analysis was good,and the fitting regression curve was:IgG4(Beckman)=0.8597×IgG4(Siemens)+0.1319.Conclusion For the clinical application of Siemens instrument(supporting reagent)and Beckman instrument(with a

关 键 词：IGG4相关性疾病 血清 IGG4 散射免疫比浊法 

分 类 号：R392-33[医药卫生—免疫学]