ELISA实验基础知识培训.pptx

ELISA实验基础知识培训;1. 酶联免疫吸附实验（ELISA）基本原理及概念;第一部分 酶联免疫吸附实验（ELISA）基本原理及概念;免疫技术;5;6;7;8;9;10;11;12;13;14;15;16;17;18;;20;采用辣根过氧化物酶的原因;22;23;24;;ELISA方法的适用范围;;28;29;甲肝疫苗抗原检测的方法——双抗体夹心法;第二部分 酶联免疫吸附实验（ELISA） 定量检测应用;目录;Guidance for Industry Bioanalytical Method Validation;34;Precision should be measured using a minimum of five determinations per concentration. A minimum of three concentrations in the range of expected concentrations is recommended. The precision determined at each concentration level should not exceed 15% of the coefficient of variation (CV) except for the LLOQ, where it should not exceed 20% of the CV … which measures precision with time, and may involve different analysts, equipment, reagents, and laboratories.; Once the analytical method has been validated for routine use, its accuracy and precision should be monitored regularly to ensure that the method continues to perform satisfactorily. To achieve this objective, a number of QC samples prepared separately should be analyzed with processed test samples at interval based on the total number of samples. The results of the QC samples provide the basis of accepting or rejecting the run. At least four of every six QC samples should be within 15% of their respective nominal value. Two of the six QC samples may be outside the 15% of their respective nominal value, but not both at the same concentration.;质控品——甲型肝炎灭活疫苗内控参比品（内参） 内参设置频次 每块酶标板设置1个内参 内参成立要求 体外效力检验值在1.04-1.28之间，试验成立 内参均值1.16，其 ±15%范围 为0.99-1.33 内参实际应用情况 2013年6-7月间，内参共检验124次，其中10次不符合要求，合格率92%＞（4/6） ;目录;双抗夹心ELISA抗原定量检测应用举例;不同ELISA试剂盒验证的变异系数;不同ELISA试剂盒验证的变异系数;目录;分析模型的选择 根据不同ELISA检验方法的属性与要求，适用模型不同;为什么选择量反应平行线法进行有效抗原含量定量检验？;为什么选择量反应平行线法进行有效抗原含量定量检验？