方法学验证-医学本科毕业论文实例.doc

本科毕业论文报告 题 目： ELISA法定量检测HBsAg的方法学评价 姓 名： 学 号： 系 别： 年 级： 专 业： ? 指导教师： ELISA法定量检测HBsAg的方法学评价 摘 要 目的：对ELISA法定量检测乙肝表面抗原（HBsAg）进行方法学评价。方法：首先制定标准曲线，配制中，高，低，三种浓度的质控品，用ELISA法进行5次批内重复试验，与另外两组测定结果进行批间重复性测定，从而进行准确度和精密度的评估。结果：标准曲线回归方程为：y = 0.1676x+0.0121，相关系数 r = 0.9928.HBsAg检测的回收率(高值、中值、低值)分别为104.9％、106.0％ 、109.1％；HBsAg批内重复性(高值、中值、低值)RSD分别为6.97％ 、8.11％、8.68％ ，批间重复性(水平1、水平2，水平3)CV分别为9.15％、12.16％ 、16.81％ ，均满足要求；结论:用ELISA法定量检测HBsAg，其准确度和精密度能够满足临床定量分析的要求。 关 键 词 乙肝表面抗原（HBsAg）；方法学评价；ELISA法；定量检测 ELISA quantitative detection of HBsAg methodology evaluation Abstract Objective: to ELISA quantitative detection antigen of second liver surface (HBsAg) methodology evaluation. Methods: first to establish a standard curve, configuration, high, low, three of the concentration of the product to control the five group of repeating test, and the other two groups on the determination results between determination of repetitive, and thus for accuracy and precision evaluation. Results: of HBsAg in repeatability (high value, median, low value) variation coefficient (CV) respectively for %, %, %, between of repeatability (level 1, level 2) CV were 9.6%, 4.9%, and can satisfy the requirements; HBsAg, this test negative rate was 100%; The health ministry clinical inspection center room asked quality evaluation result and patient samples results Yin, positive coincidence rate all for 100%. Conclusion: this system the detection performance meet the manufacturer of a given parameters and quality objectives, and can satisfy the requirements of clinical quantitative analysis. Key words Hepatitis b surface antigen (HBsAg)；Methodology evaluation；ELISA; Quantitative detection 中文摘要………………………………………………………………………………I 英文摘要……………………………………………………………………………I 前言……………………………………………………