医学检验本科毕业论文范例供参考

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..................................................................................................................

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)

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.