Fraser C G, Petersen P H
Directorate of Biochemical Medicine, Ninewells Hospital and Medical School, Dundee, Scotland.
Arch Pathol Lab Med. 1995 Oct;119(10):909-13.
Many strategies exist for the delineation of desirable performance standards for imprecision and inaccuracy (bias). All have disadvantages and advantages. Currently, the professional consensus is that the favored approach is based on biology: desirable imprecision is less than one half of the within-subject biological variation and desirable inaccuracy is less than one quarter of the group (within-subject plus between-subject) biological variation. Current laboratory performance allows these goals to be met for many quantities. In the past, analyses done at sites other than the laboratory achieved poorer results, but recent advances in technology appear to allow some biology-based goals, which in our view are the appropriate standards, to be met. Further advances in setting and widely promulgating goals, making good calibrants widely available, and developing quality control, assessment, and management are all required to ensure that the desirable performance standards are obtained in all locations in the future.
存在多种用于确定不精密度和不准确度(偏差)的理想性能标准的策略。所有策略都各有优缺点。目前,专业共识是,首选方法基于生物学:理想的不精密度应小于个体内生物学变异的一半,理想的不准确度应小于组内(个体内加个体间)生物学变异的四分之一。当前的实验室性能使许多检测指标能够实现这些目标。过去,在实验室以外的场所进行的分析结果较差,但最近的技术进步似乎使一些基于生物学的目标(我们认为这是合适的标准)得以实现。在设定和广泛公布目标、广泛提供优质校准物以及发展质量控制、评估和管理方面进一步取得进展,对于确保未来在所有场所都能达到理想的性能标准都是必要的。