基于化学发光磁微粒免疫分析技术检测血清Lp- PLA2浓度  

The Detection of the Concentration of Lp-PLA2 in Serum Based on Magnetic Particle Chemiluminescence Immunoassay

作　　者：李慧杰 周佩洋 杨进波 丁艳 LI Huijie;ZHOU Peiyang;YANG Jinbo;DING Yan(Department of Clinical Laboratory,Xiangyang No.1 People’s Hospital,Hubei University of Medicine,Xiangyang 441000,China;Department of Neurology,Xiangyang No.1 People’s Hospital,Hubei University of Medicine,Xiangyang 441000,China)

机构地区：[1]湖北医药学院附属襄阳市第一人民医院检验科,湖北襄阳441000 [2]湖北医药学院附属襄阳市第一人民医院神经内科,湖北襄阳441000

出　　处：《标记免疫分析与临床》2023年第9期1571-1576,共6页Labeled Immunoassays and Clinical Medicine

基　　金：湖北省科技计划项目(编号:2021CFB567)。

摘　　要：目的 建立一种脂蛋白相关性磷脂酶A2(Lp-PLA2)直接化学发光免疫分析方法并进行性能评价。方法 根据双抗夹心法原理,将磁珠-Lp-PLA2抗体1(MAb, Coating)与血清中的Lp-PLA2抗原以及吖啶酯-Lp-PLA2抗体2(MAb, Labeling)反应形成免疫复合物,磁场吸附清洗,加入预激发液和激发液后仪器检测反应过程中相对发光单位(RLU),通过标准曲线方程计算样本中Lp-PLA2浓度,并对试剂各项性能进行评估。结果 本方法空白限为0.5ng/mL,线性范围为5~1 000ng/mL,回收率在85%~115%范围内,批内精密度为2.26%~3.80%,批间精密度为3.82%~4.63%,特异性和抗干扰能力符合要求,与热景Lp-PLA2检测试剂盒比对相关系数r=0.9874。结论 本方法各项性能指标均达到临床检验质量要求,与现有试剂盒比对结果具有较好的一致性,可供广大研究者借鉴参考。Objective To develop a direct chemiluminescence immunoassay for Lp-PLA2 and to evaluate its performance.Methods According to the principle of double antibody sandwich method,we conducted a series of experiments as follows:Mag-Lp-PLA2 antibody 1(mAb,coating)reacted with Lp-PLA2 antigen in serum and AE-Lp-PLA2 antibody 2(mAb,labeling)to form immune complex;adding re-trigger solution and trigger solution after magnetic field adsorption and performing cleaning;the relative light unit(RLU)in the reaction process was detected by the instrument;the concentration of Lp-PLA2 in the sample was calculated through standard curve equation;and the performance of the reagent was then evaluated.Results The minimum detection limit of this method was 0.5 ng/mL,while the linear range was 5-1000ng/mL,and the recovery was in the range of 85%-115%.The intra-batch coefficient of variation was 2.26%-3.80%,and the inter-batch coefficient of variation was 3.82%-4.63%.The specificity and anti-interference ability met the requirements.Compared with the hotgen Lp-PLA2 detection kit,the correlation coefficient was r=0.9874.Conclusion The performance indexes of the studied method can meet the quality requirements of clinical test,and it has a good correlation with an existing kit,which can be used as a reference for researchers.

关 键 词：脂蛋白相关性磷脂酶A2 化学发光免疫分析 临床检验 

分 类 号：R446.6[医药卫生—诊断学]