化学发光免疫法检测甲胎蛋白的生物检测限和功能灵敏度研究

目的建立化学发光免疫法检测甲胎蛋白的生物检测限和功能灵敏度。方法参照相关文献,甲胎蛋白空白样品及系列稀释浓度样品在Bayer Centaur240化学发光免疫检测系统进行检测,计算其光强度均值、标准差及变异系数,确定该方法的检测低限、生物检测限和功能灵敏度。结果方法的检测低限为1.00ng/ml,低于厂家声明。生物检测限在2.65～3.53ng/ml之间,功能灵敏度为3.53ng/ml。结论各实验室应自行建立肿瘤标志物的生物检测限和功能灵敏度,才能为临床诊断和治疗提供更有价值的信息。

Research on Biologic Limit of Detection and Functional Sensitivity of Chemiluminescence Immunoassay in the Detection of AFP

Objective To establish the biologic limit of detection and functional sensitivity of chemiluminescence immunoassay in detection of AFP.Methods Referring to pertinent literature, the RLUs of blank and a serial diluted samples detected by Bayer Centaur 240 chemiluminescense immunoassay system would be calculated to average value, standard deviations and coefficient of variance,which to establish the low limit of detection ,biologic limit of detection and functional sensitivity of AFP.Results The low limit of detection was 1.00 ng/ml and it was lower than the declaration of the manufacturer.The biologic limit of detection was between 2.65 ng/ml and 3.53 ng/ml.The functional sensitivity was 3.53 ng/ml.Conclusion The biologic limit of detection and functional sensitivity must be established in laboratories,which can provide more important information for the clinic.