校准和校准验证在临床血液学实验室中的应用课件.ppt

校准和校准验证在临床血液学实验室中的应用;主要内容;检测方法的分类;IFCC对方法分类的定义;标准品;;一级标准;来源：人样品混合物如混合血清，添加某些分析物增加含量。处理过的样品，和新鲜样品有着新的基质差异。 定值方法：无法由称量法和容量法确定，只能依赖于分析方法。校准值只能取决于分析方法和检测系统。;检测系统; 标准化的各要素;;;溯源性（Traceability）;校准值不是测定值，是纠正的调整值。;溯源性要求对实际工作的几点启示;主要内容;校准及校准验证过程;校准;校准验证;校准验???频率;校准验证材料; AMR VALIDATION is the process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The materials used for validation must be known to have matrix characteristics appropriate for the method. The matrix of the sample (i.e. the environment in which the sample is suspended or dissolved) may influence the measurement of the analyte. In many cases, the method manufacturer will recommend suitable materials. At a minimum, three test specimens must have analyte values, which are near the low, midpoint, and high values of the AMR. Specimen target values can be established by comparison with peer group values for reference materials, by assignment of reference or comparative method values, and by dilution or admixture ratios of one or more specimens with known values. Each laboratory must define limits for accepting or rejecting validation tests of the AMR. AMR验证是确认检测系统将正确还原被分析物在AMR的浓度或活性的过程。用于验证的材料必须有适当的基质特征的。样品的基质（即样品悬浮或溶解的环境）可能会影响分析物的测量。在许多情况下，制造商将推荐合适的材料。至少，三个测试样必须有分析值，其接近AMR的低，中间，和高值。样本目标值可通过同行间比对参考物质，或由比较方法或参考方法赋值，并通过稀释或混合一个或一个以上的已知值样品。每个实验室必须定义AMR验证可接受限或拒绝限。;AMR验证材料;主要内容;凝血试验的校准及校准验证;基于凝固法试验的校准及校准验证;INR的校准及校准验证;基于免疫学或其他方法直接测量分析物浓度/活性试验的校准及校准验证 ;主要内容;参考文件;全血细胞计数校准频率;全血细胞计数校准（重新校准）;全血细胞计数校准验证;全血细胞计数AMR 验证;其他项目校准及校准验证;谢 谢！