医学检验本科毕业论文范例-供参考 1 / 10 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： 张珊 学 号： 系 别： 年 级： 专 业： 医学检验

指导教师：

二 ○一 一 年 十二 月 目 录 中文文献.......................................................................................................................... 英文摘要.......................................................................................................................... 前 言.............................................................................................. 错误!未定义书签。 1. 材料及方法............................................................................... 错误!未定义书签。 1.1 试剂盒.............................................................................................................. 1.2 仪器.................................................................................................................. 1.3 方法.................................................................................................................. 医学检验本科毕业论文范例-供参考 2 / 10 1.3.2．铺板方案................................................................................................ 1.3.3．加样步骤................................................................................................ 2. 结果............................................................................................................................. 2.1 标准曲线及线性范围........................................................................................ 2.2 准确度（回收率）的验证.............................................................................. 2 2.3 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 ..................................................................................... 5 3. 讨论........................................................................................................................... 5 3.1 乙肝表面抗原定量分析的意义...................................................................... 5 3.2 常用定量分析方法.......................................................................................... 6 3.3 方法概述.......................................................................................................... 6 3.4 方法学验证内容.............................................................................................. 6 3.5 结果分析及应用评价...................................................................................... 7 参考文献........................................................................................................................ 7 医学检验本科毕业论文范例-供参考

I / 10 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/ml 3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

The reification of the HBsAg ELISA quantitative methodology Abstract Object: to verify the quantitative methodology of Fuzhou blueprint biological engineering company to make sure whether it ca be used to the analysis of Clinical Sample. Methods: ELISA quantitative methodology , make an Application of the standard HBsAg kit from the concentration of 8 ng/ml do 2 times diluted six concentration gradient to constitute a standard curve, testing With 6, 3, 1.5 ng/ml 3 a concentration gradient 5 accurately precise and detection .Results: standard curve ,R2=0.997, the accuracy of RSD of 1.5ng/m is 16.78%，the RSD that cannot meet the demand of ng/ml basic level is less than <15% in common. The LOD is 0.172ng/ml, the testing of Low concentration samples （<1.5ng/ml）are lower than high concentration samples in both accuracy and precision , which as a result make it unsuitable for low concentration sample testing. Conclusion: the ELISA quantitative analysis kit of HBsAg cannot be used for the analysis of Clinical Sample.

Key words HBsAg Quantitative analysis Verification Methodology.