ELISA试验基础知识培训（45页）.pptxVIP

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;免疫技术;5;6;7;8;9;10;11;12;13;14;15;16;17;18;酶;20;采用辣根过氧化物酶的原因;22;23;24;捕获法;ELISA方法的适用范围;用途广泛;双抗体夹心法;29;甲肝疫苗抗原检测的方法——双抗体夹心法;第二部分;目录;FDA 对生物分析方法验证的要求;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. 生物分析方法精密度评价的规定： ?对生物分析方法进行精密度检测实验时，检测范围内最少设置 3个不同浓度，每个浓度最少进行 5次重复试验。 ?考察因素：时间、人员、设备、试剂和实验室 ——导致结果的因素 ?验证结果：在相同浓度下，试验结果 变异系数CV 应小于15% （最低检出限的要求是CV 小于20% ）。;Application of validated method to routine drug analysis 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.;举例说明;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？