论文部分内容阅读
目的对索林LIAISON XL化学发光免疫分析系统主要性能进行评价。方法以CLSI(美国临床实验室标准化委员会)制定的评价标准,通过一系列实验设计,对索林LIAISON XL化学发光免疫分析系统乙肝两对半检测的精密度、线性范围、符合率、分析灵敏度等进行评价。结果 LIAISON XL化学发光免疫分析系统进行乙肝两对半检测,批内不精密度CV在1.56~3.07%,批间不精密度在2.64~5.44%,HBsAg、HBsAb、HBeAg的分析灵敏度分别为0.03IU/ml、5 mlU/ml、0.01PEIU/ml。结论 LIAISON XL化学发光免疫分析系统各方面性能良好,测定样本快速,准确度精密度可靠,能适应医院临床样本的检测需要。“,”Objective Analytical performance of the chemiluminescence immunoassay system in Liaison. Methods The precision, accuracy, linearity and sensitivity analysis of HBV markers were validated according to Clinical and Laboratory Standards Institute (CLSI) documents through a series of experimental design. Results The intra-and inter-precisions of HBV markers by LIAISON XL were 1.56%~3.07%and 2.64%~5.44%, respectively. The sensitivity analysis of HBsAg, HBsAb and HBeAg were 0.03IU/ml, 5 mlU/ml and 0.01 PEIU/ml, respectively. Conclusion Liaison is suitable for clinical application with good precision, accuracy and faster detection speed.