临床检验方法评价决定图的制作及应用

目的介绍一种新的图形工具用于对分析方法性能作出决定。方法制作方法评价决定图,需要以允许总误差(TEa)形式规定分析质量要求。在图上,Y轴为“允许不准确度[偏倚(b ias)]”,其刻度为0至TEa,X轴为“允许不精密度[变异系数(CV)],其刻度为0至1/2TEa,画出通过Y轴上的TEa点和X轴上的1/2TEa点的b ias 2s线,画出通过Y轴上的TEa点和X轴上的1/3TEa点的b ias 3s线,画出通过Y轴上的TEa点和X轴上的1/4TEa点的b ias 4s线,并在图上相应的区域标记出“差、边界、良好、优秀”。结果方法评价决定图与操作过程规范图有着密切的关系,并提供了将方法性能分为差、良好或优秀的指南。结论借助于方法评价决定图很容易并快速地作出方法性能的客观决定。

The preparation and application of method evaluation decision chart

Objective To introduce a new graphical tool that makes decisions about method performance. Methods To prepare a method evaluation decision chart for a test of interest,define the analytical quality requirement in the form of a total allowable error(TEa).Label the Y-axis "allowable inaccuracy(bias)" and scale from 0 to TEa,label the X-axis "allowable imprecision(CV)" and scale from 0 to (0.5) TEa,draw a line for bias 2s from TEa on the Y-axis to(0.5) TEa on the Xaxis,draw a line for bias 3s from TEa on the Y-axis to(0.33) TEa on the Xaxis,draw a line for bias 4s from TEa on the Y-axis to(0.25) TEa on the X-axis,label the regions "poor,marginal,good,and excellent," as shown in the figure. Results Relationship to charts of operating specifications(OPSpecs charts) provides guidance for classification of performance as poor,good or excellent. Conclusions Objective decisions on the performance of methods can be made quickly and easily with the aid of a method evaluation decision chart.