毕 业 论 文
题 目：乙肝表面抗原的ELISA法定量分析方式学验证
姓 名： 张珊
学 号：
系 别：
年 级：
专 业： 医学查验
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. 材料与方式 ...............................................................................错误!未定义书签。
1.1 试剂盒 ............................................................................................................. 1.2 仪器 ................................................................................................................. 1.3 方式 .................................................................................................................
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 ............................................................................. 2 2.3 周密度的验证 ...................................................................................................
2.3.1 板内周密度的验证 ................................................................................. 2.3.2 板间周密度的验证 ................................................................................. 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 经常使用定量分析方式 ................................................................................. 6 3.3 方式概述 ......................................................................................................... 6 3.4 方式学验证内容 ............................................................................................. 6 3.5 结果分析及应用评判 ..................................................................................... 7 参考文献 ....................................................................................................................... 7
乙肝表面抗原的ELISA法定量分析方式学验证
摘 要
目的：对福州蓝图生物工程生产的HBsAg的ELISA法定量分析试剂盒进行方式学验证，以判定是不是能用于临床样本分析。方式：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，周密度和检测限等方式学验证。结果：标准曲线R2=0.997，准确度97.07%，1.5ng/ml的RSD为16.78%，不知足ng/ml级水平的RSD一样应<15%的要求，检测限LOD为0.172ng/ml，
低浓度样品（<1.5ng/ml）的检测在准确性和周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 方式学验证
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.
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