胶乳增强免疫比浊法NSE诊断试剂盒性能验证及临床应用  

A Performance Validation and Clinical Application of Latex Enhanced Immunoturbidimetric NSE Diagnostic Kit

作　　者：白晶[1] 刘瑜[1] 蒲云罡 刘向祎[1] BAI Jing;LIU Yu;PU Yungang;LIU Xiangyi(Department of Clinical Laboratory,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China)

机构地区：[1]首都医科大学附属北京同仁医院检验科,北京100730

出　　处：《标记免疫分析与临床》2024年第7期1315-1320,共6页Labeled Immunoassays and Clinical Medicine

基　　金：2022年北京市高层次公共卫生技术人才培养计划(编号:2022-3-045)。

摘　　要：目的对胶乳增强免疫比浊神经元特异性烯醇化酶(neuron-specific enolase,NSE)试剂盒进行性能验证。方法按照CNAS-GL037:2019《临床化学定量检验程序性能验证指南》、WS/T492-2016《临床检测定量测定项目精密度与正确度性能验证》并结合试验工作,重新设计了检验方法,在贝克曼库尔特AU5800全自动生化分析对北京九强金斯尔NSE胶乳增强免疫比浊法试剂盒的正确度、精密度、线性范围、可报告范围和生物参考区间等性能进行验证和评估,并与对应罗氏电化学发光法试剂盒进行方法学比对。测试结果与厂家所给出的产品分析性能以及美国国家卫生委员会临床检测中心(National Center for Clinical Laboratories,NCCL)的相关指标进行了对比。结果5个水平的正确度偏倚分别为1.74%、-1.42%、-0.88%、-3.09%和-0.90%;2个水平的批内及批间精密度的变异系数(coefficient of variation,CV)分别为1.85%和0.88%(判断标准CV<7.5%),4.99%和3.34%(判断标准CV<10%);线性范围(3.5~148.1ng/mL)验证回归系数a值为0.9894,R2=0.9978;最大稀释倍数为8倍,临床可报告上限为1165.2ng/mL;厂家提供的生物参考区间为0~16.3ng/L,符合率R为100%,各性能均通过验证。此外,与罗氏电化学发光试剂盒进行方法学比对,其相关性分析结果为:两种方法的相关性(R2=0.989)、一致性(CCC=0.984)均较好,在临床判定效果上同Roche的电化学发光试剂盒相比,免疫增强比浊方法阳性符合率为95.74%,阴性符合率为96.23%,两者测定值接近,相关系数达0.9894。结论基于全自动生化分析平台测定的NSE胶乳增强免疫比浊试剂盒,各性能均可以较好地满足临床使用要求,且与电化学发光法检测结果一致性较好,有望进一步推进NSE国产体外诊断试剂盒的临床应用。Objective To validate the performance of latex enhanced immunoturbidimetry neuron-specific enolase(NSE)kit.Methods In accordance with CNAS-GL037:2019《Performance Verification Guidelines for Clinical Chemistry Quantitative Testing Procedures》and WS/T492-2016《Performance Verification of Precision and Correctness of Clinical Testing Quantitative Determination Items》and combined with the experimental research,the test method was redesigned,and the correctness,precision,linear range of Beijing Jiuqiang Kingsl NSE Latex Enhanced Immunoturbidimetric Assay Kit were evaluated with Beckman Coulter AU5800 automatic biochemical analysis.Performance parameters,including reporting ranges and biological reference intervals,were validated and evaluated,and methodological comparisons were performed with the corresponding Roche electrochemiluminescence kits.The test results were compared to the analytical performance of the product as reported by the manufacturer and the quality index of the National Center for Clinical Laboratories(NCCL)of the U.S.National Health Commission.Results The correctness bias of the five levels were 1.74%,-1.42%,-0.88%,-3.09%and-0.90%,respectively.The coefficient of variation(CV)for intra-and inter-assay precision were 1.85%and 0.88%(7.5%<CV),4.99%and 3.34%(CV)for intra-and inter-assay precision,respectively<10%;The linear range(3.5-148.1ng/mL)validation regression coefficient value was 0.9894,(R 2=0.9978);The maximum dilution factor was 8 times,and the upper limit of clinical reportability was 1165.2ng/mL.The biological reference interval provided by the manufacturer was 0-16.3ng/mL,the coincidence rate R was 100%,and all the properties were validated.In addition,the correlation analysis results showed that the correlation(R 2=0.989)and consistency(CCC=0.984)of the two methods were good,and compared with Roche’s electrochemiluminescence kit,the positive coincidence rate of the immune-enhanced turbidimetry method was 95.74%and the negative coincidence rate was 96.23%.The measured values of the

关 键 词：NSE 胶乳免疫比浊法 生化分析仪 性能验证 方法学比对 

分 类 号：R-331[医药卫生]