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:专业:指导教师:教师职称:研究起止日期:研究提交日期:二○一三年十一月目录毕业论文乙肝表面抗原的ELISA法定量分析方法学验证中文摘要................................................................................................1英文摘要................................................................................................1前言........................................................................................................21.材料与方法.........................................................................................31.1试剂盒........................................................................................31.2仪器.............................................................................................31.3方法.............................................................................................31.3.1溶液配制...........................................................................41.3.2铺板方案...........................................................................41.3.3加样步骤...........................................................................52.结果....................................................................................................62.1标准曲线与线性范..................................................................62.2准确度(回收率)的验证......................................................62.3精密度的验证..........................................................................72.3.1板内精密度的验证.........................................................72.3.2板间精密度的验证.........................................................82.4检测限(LOD)计算.............................................................103.讨论...................................................................................................103.1乙肝表面抗原定量分析的意义.............................................103.2常用定量分析方法.................................................................113.3方法概述................................................................................113.4方法学验证内容....................................................................123.5结果分析及应用评价.............................................................13参考文献................................................................................................14综述........................................................................................................15致谢........................................................................................................18乙肝表面抗原的ELISA法定量分析方法学验证中文摘要目的: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法定量分析试剂盒不能用于临床标本的分析。关键词:乙肝表面抗原ELISA定量分析方法学验证ThereificationoftheHBsAgELISAquantitativmethodologyAbs...