毕业论文题目:乙肝表面抗原的ELISA法定量分析方法学验证姓名:学号:系别:年级:专业:指导教师:二○一一年十二月目录中文文献..........................................................................................................................英文摘要..........................................................................................................................前言..........................................................................Error:Referencesourcenotfound1.材料与方法...........................................................Error:Referencesourcenotfound1.1试剂盒................................................................................................................1.2仪器....................................................................................................................1.3方法....................................................................................................................1.3.2.铺板方案................................................................................................1.3.3.加样步骤................................................................................................2.结果..............................................................................................................................2.1标准曲线与线性范围.........................................................................................2.2准确度(回收率)的验证...............................................................................22.3精密度的验证.....................................................................................................2.3.1板内精密度的验证...................................................................................2.3.2板间精密度的验证...................................................................................2.4检测限(LOD)计算.......................................................................................53.讨论............................................................................................................................53.1乙肝表面抗原定量分析的意义.......................................................................53.2常用定量分析方法...........................................................................................63.3方法概述...........................................................................................................63.4方法学验证内容...............................................................................................63.5结果分析及应用评价.......................................................................................7参考文献........................................................................................................................7乙肝表面抗原的ELISA法定量分析方法学验证摘要目的:对福州蓝图生物工程有限公司生产的HBsAg的ELISA法定量分析试剂盒进行方法学验证,以判断是否能用于临床样本分析。方法:ELISA法定量分析,应用试剂盒HBsAg标准品从浓度为8ng/ml做2倍稀释的6个浓度梯度做标准曲线,以6,3,1.5ng/ml3个浓度梯度5复孔做准确度,精密度和检测限等方法学验证。结果:标准曲线R2=0.997,准确度97.07%,1.5ng/ml的RSD为16.78%,不满足ng/ml级水平的RSD一般应<15%的要求,检测限LOD为0.172ng/ml,低浓度样品(<1.5ng/ml)的检测在准确性和精密度方面都低于高浓度样品,不适合低浓度样品的检测。结论:该HBsAg的ELISA法定量分析试剂盒...