电化学发光法和即时检验法测N末端B型利钠肽原的方法学比较和性能评估  

Evaluation of NT-proBNP assay performance on POCT device and methodology comparison with electro-chemiluminescence immunoassay

作　　者：钱明理[1] 任懿倩[2] 杜坤[2] 张广慧[2] 

机构地区：[1]上海交通大学医学院附属新华医院生物医学工程室,上海200092 [2]上海交通大学医学院附属新华医院检验科,上海200092

出　　处：《诊断学理论与实践》2012年第3期273-277,共5页Journal of Diagnostics Concepts & Practice

摘　　要：目的:评价即时检验(POCT)法检测N末端B型利钠肽原(NT-proBNP)的分析性能,并与电化学发光法进行比较。方法:参照美国临床和实验室标准协会(CLSI)提供的方法学评价的EP系列文件,研究两台POCT仪器检测NT-proBNP的精密度、线性范围、方法学比对及进行评价血红蛋白、乳糜和胆红素对分析的干扰,且与厂商声明的有关标准进行比较。根据CLSI C28-A2文件,对厂商声明的生物参考区间进行验证,确定其是否适用于本实验室。结果:A仪器检测NT-proBNP的批内变异系数(CV)和总CV分别为6.96%～11.22%和7.54%～11.75%,线性范围为98.0～32 924.5 pg/mL,检测结果与Roche Cobas e411的检测结果间有较好的相关性,对测试产生干扰的干扰物浓度为乳糜浓度≥725.5 FTU、血红蛋白≥2747.7 mg/L、游离型胆红素≥180.8 mg/L、结合型胆红素≥256.9 mg/L。不同年龄组共50名参考个体中除1名的NT-proBNP浓度(127 pg/mL)超出厂商提供的参考区间外,其余均在参考范围内。B仪器检测NT-proBNP的批内CV和总CV分别为10.25%～14.23%和11.46%～14.81%,线性范围为267.82～8627.28pg/mL,检测结果与Roche Cobas e411的检测结果间有细微的差异,对测试产生干扰的干扰物浓度为乳糜浓度≥694.98 FTU、血红蛋白≥3490.9 mg/L、游离型胆红素≥172.2 mg/L、结合型胆红素≥303.1 mg/L。不同年龄组共50名参考个体NT-proBNP浓度除了一个检测值(305.72 pg/mL)超出厂商提供的参考区间外,其余均在参考范围内。结论:A仪器(免疫荧光法)检测NT-proBNP的主要分析性能达到厂商声明的性能及相关质量的要求,B仪器(胶体金免疫层析法)除与电化学发光法的方法学比较上有差异外,其余分析性能也达到厂商声明的性能和有关质量要求。Objective： To evaluate the analytical performance of NT-proBNP on POCT（point-of-care testing） device and compare with that of electro-chemiluminescence immunoassay.Methods The precision,linearity,methodology comparison and analytical anti-interference ability of NT-proBNP assay on two POCT devices were evaluated according to the EP documents issued by Clinical and Laboratory Standards Institute（CLSI）.In addition,the analytical performance data were compared with the standards declared by the manufacturer.The biological reference intervals were verified according to CLSI C28-A2 document to define whether it could be used in our laboratory.Results The within-run CV（coefficient of variation） and total CV of device A were 6.96%-11.22% and 7.54%-11.75%,respectively,and the linearity range was 98.0 pg/mL-32 924.5 pg/mL.The results of device A were comparable to that of the Roche Cobas e411.Interference in NT-proBNP assay occurred when hemoglobin was over 2747.7mg/L,chyle was over 725.5FTU,free bilirubin was over 180.8 mg/L,and conjugated bilirubin was over 256.9 mg/L.Except one test datum（127pg/mL）,all the test data from 50 individuals of various age groups were in the range of biological reference intervals declared by the manufacturer.The within-run CV and total CV of device B were 10.25%-14.23% and 11.46%-14.81%,respectively,and the linearity range was（267.82-8627.28）pg/mL.The results of device B had slight deviation when compared with that of the Roche Cobas e411.Interference of NT-proBNP assay was seen when hemoglobin was over 3490.9mg/L,chyle was over 694.98FTU,free bilirubin was over 172.2mg/L,and conjugated bilirubin was over 303.1mg/L.Except one test datum（305.72pg/mL）,all the test data from 50 individuals of various age groups were in the range of biological reference intervals declared by the manufacturer.Conclusions The analytical performance of device A is in the range of standards declared by the manufacturer.The analytical performance of device B is also in the range of standard

关 键 词：即时检验 电化学发光 N末端B型利钠肽原 性能评价 

分 类 号：R446.1[医药卫生—诊断学]