McDonagh B F
Comput Programs Biomed. 1977 Sep;7(3):179-90. doi: 10.1016/0010-468x(77)90026-5.
Methods for statistical quality control for the clinical laboratory in general, and radioimmunoassay in particular, have been proposed for many years. Unfortunately, only a very small number of laboratories have adapted these procedures. By use of teletypes and other remote terminals, it is possible for all laboratories to access centralized computers where a general purpose quality control program can be stored. This relieves each laboratory of the costly task of developing software, provides some degree of inter-laboratory standardization and facilitates comparison of precision and accuracy between laboratories. A prototype program for this purpose is described. This program evaluates within-assay and between-assay variability, by means of an analysis of variance for a one-way classification random-effects model, and can monitor any assay parameter by use of control chart techniques. In addition, several tests are provided to evaluate the temporal stability of the assay system, and appropriate tests for outliers are included. Also, methods are described for combination of information from several quality control samples. This provides a valid basis for adjustment of assay results or for outright rejection of an assay. For convenience, this program is designed for output on a teletype or similar terminal located in the laboratory. Simplified versions of this program can be readily adapted to desk-top calculators. The original purpose for developing this system was to provide the clinical laboratory with a simple, general, and flexible method for assessing the performance of radioimmunoassays, but its usefulness should extend to virtually all assay methods.
总体而言，针对临床实验室，特别是放射免疫分析的统计质量控制方法已提出多年。遗憾的是，只有极少数实验室采用了这些程序。通过使用电传打字机和其他远程终端，所有实验室都能够访问集中式计算机，在那里可以存储通用的质量控制程序。这免除了每个实验室开发软件的昂贵任务，提供了一定程度的实验室间标准化，并便于比较各实验室之间的精密度和准确度。本文描述了一个用于此目的的原型程序。该程序通过对单向分类随机效应模型进行方差分析来评估批内和批间的变异性，并可使用控制图技术监测任何分析参数。此外，还提供了几个测试来评估分析系统的时间稳定性，并包括了针对异常值的适当测试。同时，还描述了组合来自多个质量控制样本信息的方法。这为调整分析结果或直接拒绝一项分析提供了有效的依据。为方便起见，该程序设计为在实验室中的电传打字机或类似终端上输出。该程序的简化版本可轻松适配到台式计算器。开发此系统的最初目的是为临床实验室提供一种简单、通用且灵活的方法来评估放射免疫分析的性能，但其用途实际上应扩展到几乎所有分析方法。
