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 information for the clinical diagnosis and therapy.%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Roche Cobas E601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2.53 pg/ml,检出限为7.75 pg/ml,10％ CV时的功能灵敏度为8.82 pg/ml.结论 建立了Roche Cobas E601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.
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