临床检验方法的评价CLSIEP文件.ppt

定量分析方法的线性评价 Evaluation of The Linearity of Quantitative Analytical Methods EP6-P 目的 为实验室中采用定量分析方法的用户提供评价仪器或方法是否满足厂家线性指标的评价方法。 用户可为分析方法设定线性范围。 定义 Assay Range（Linear Range) The range of concentration or activity in which the final output value of a system is proportional to the analyte concentration or activity within a stated tolerance. 定义 Linearity: The measure of the degree to which a curve approximates a straight line. It refers to overall system response (i.e., the final analytical answer rather than the instrument output) Scope and Limitations 线性是分析方法的一个特征，不同于准确性和精密度。 线性实验应该使用与待分析物基质相似