Roche电化学发光免疫法检测NT—proBNP的检测限值和功能灵敏度研究

Research on Limits of Detection and Sensitivity of Roche Electrochemiluminescence Immunoassay in the Detection of NT-proBNP

目的探讨电化学发光免疫法检测N末端B型利钠肽原（NT—proBNP）的检测限值和功能灵敏度。方法参照美国临床和实验室标准化协会（CLSI）Ep-17A文件制备空白样品及系列低浓度样品。‘空白样品采用配套的稀释液，系列低浓度样品采用倍比稀释的方法获得。样品制备后用RocheCobasE601电化学发光免疫系统检测NT-proBNP浓度，以确定该方法的空白限、检出限和功能灵敏度。结果NT—proBNP的空白限为2．53pg／ml，检出限为7．75pg／ml，10％CV时的功能灵敏度为8．82pg／ml。结论建立了RocheCobasE601电化学发光免疫系统检测NT-proBNP的空白限、检出限和功能灵敏度，为临床诊断和治疗提供了更有价值的信息。

Objective To evaluate the limits of detection and functional sensitivity of electro-chemiluminescence immunoassay in detection of NT-proBNP using Clinical and Laboratory Standards Institute（CLSI）EP-17A. Methods Blank and a serial low consistency samples were detected by Roche Cobas E601 electrochemiluminescence immunoassay system to establish the limit of blank,limit of detection and functional sensitivity of NT-proBNP. Suporting diluent was blank sample and a serial low consistency samples were abtained by dilution. Results The limit of blank and limit of detection of NT-proBNP was 2.53 pg/ml,7.75 pg/ml,respectively. The functional sensitivity was 8. 82 pg/ml. Conclusion The limit of blank,limit of detection and functional sensitivity were established successfully in laboratories, which could provide more important infor- mation for the clinical diagnosis and therapy.