电化学发光免疫法检测NT—proBNP的分析性能评价

Evaluation of NT-proBNP assay performance on electro-chemiluminescence immunoassay system

目的 评价电化学发光免疫法检测NT-proBNP的分析性能.方法 参考CLSI发布的方法学评价系列文件,对Roche Cobas E601电化学发光免疫系统检测NT-proBNP的精密度、正确度、空白限（LoB）和检出限（LoD）、功能灵敏度（FS）、分析测量范围（AMR）、最大稀释度、临床可报告范围（CRR）以及胆红素、血红蛋白和乳靡对分析的干扰进行评价,并与厂商声明的性能和有关的质量标准进行比较.根据CLSI C28-A2文件,选择18～74岁的健康体检者80名,按年龄分为4组,每组20名,以验证厂商声明的生物参考区间的适用性.结果 电化学发光免疫法检测NT-proBNP的批内CV和总CV分别为1.1％ ～2.2％和1.5％ ～2.9％,与卫生部临床检验中心室间质量评价调查品同方法组的均值和配套校准品标示值的偏差分别为2.7％ ～5.9％和2.7％～7.5％,LoB、LoD和FS分别为2.5、7.8和8.8 pg/ml,AMR为8～35 126 pg/ml,最大允许稀释度为1∶2,CRR为9～70 252 pg/ml,胆红素（428 μmol/L）、血红蛋白（2 g/L）和乳靡（2 200 FIU）对NT-proBNP测定无干扰.不同年龄组各20名健康参考个体NT-proBNP浓度除1个检测值（167 pg/ml）超出厂商提供的参考区间外,其余均在厂商提供的参考区间内.结论Roche Cobas E601电化学发光免疫系统检测NT-proBNP的主要分析性能达到了厂商声明的性能和有关的质量要求,建立的LoD、FS、最大稀释度和CRR可为临床提供更好的质量保证,厂商声明的生物参考区间可满足临床需要.

Objective To evaluate analytical performance of NT-proBNP on Electro-Chemiluminescence Immunoassay system.Methods The precision,accuracy,limit of blank （ LoB ）,limit of detection （LoD）,functional sensitivity （FS）,analytical measure range （AMR）,maximal dilution rate,clinical reportable range（CRR） and the analytical anti-interference ability of NT-proBNP were evaluated according to EP documents issued by CLSI and related references.The analytical performance data were compared to quality standards declared by the manusfacturers.According to CLSI C28-A2,80 healthy volunteers,aged from 18 to 74, were chosen and divided into 4 groups on average for biological reference intervals verification.Results The within-run CV and total CV were 1.1% -2.2% and 1.5% -2.9% respectively.The deviations from controls distributed by National Center for Clinical Laboratory and affiliated calibrators were 2.7% -5.9% and 2.7% -7.5%,respectively.The results of LoB,LoD and FS were 2.5,7.8 and 8.8 pg/ml,respectively.AMR was 8 -35 126 pg/ml,and the most suitable dilution rate was 1∶ 2,so the CRR was 9 -70 252 pg/ml.428 μmol/L bilirubin,2 g/L haematoglobin and 2 200 FIU chyle didn＇t interfere with the NT-proBNP assay.Moreover,almost all the data from different age groups were in the range of biological reference intervals declared by the manusfacturers, except one test data （167 pg/ml）.Conclusions The analytical performance of NT-proBNP analyzed on Roche Cobas E601 electrochemiluminescence immunoassay system is consistent with the standarls which manufacturers has proclaimed.The establishment of LoD,FS,maximal dilution and CRR for NT-proBNP assay could provide the quality assurance for clinical use and the biological reference intervals declared by manusfacturers could meet the clinical needs.