Linnet K
Department of Clinical Chemistry, University Hospital, Copenhagen, Denmark.
Clin Chem. 1989 Jul;35(7):1416-22.
Design of control charts for the mean, the within-run component of variance, and the ratio of between-run to within-run components of variance is outlined. The between-run component of variation is the main source of imprecision for analytes determined by an enzymo- or radioimmunoassay principle; accordingly, explicit control of this component is especially relevant for these types of analytes. Power curves for typical situations are presented. I also show that a between-run component of variation puts an upper limit on the achievable power towards systematic errors. Therefore, when the between-run component of variation exceeds the within-run component, use of no more than about four controls per run is reasonable at a given concentration.
概述了均值控制图、批内方差分量控制图以及批间与批内方差分量之比控制图的设计。对于通过酶免疫分析或放射免疫分析原理测定的分析物，批间变异分量是不精密度的主要来源；因此，对该分量进行明确控制对于这类分析物尤为重要。给出了典型情况下的功效曲线。我还表明，批间变异分量对系统误差的可实现功效设置了上限。因此，当批间变异分量超过批内变异分量时，在给定浓度下每次运行使用不超过约四个质控品是合理的。
