Naka H
Nihon Rinsho. 1995 Sep;53(9):2213-9.
Although the basic concept for quality control of enzyme immunoassay (EIA) is the same as that of quality control of the usual chemical analysis, immunological analytic methods including enzyme immunoassay have some specific features depending on the method as compared with the chemical method. In addition to the usual QC method, therefore, it is necessary to add some QC techniques to control the variables derived from the method. In accuracy control of EIA, standard materials, reagents and analytical equipment will be the major sources of error. Points to be considered in accuracy control are described. In precision control of EIA, between-run precision is generally larger than within-run precision. In consideration of the characteristics, mean-Rs-R control chart method and Z-V control chart method appropriate for immunological method are described. Analytical sensitivity expressed as detectability and detection limits is very important in EIA. A procedure to determine the detection limits is described in detail. Between reagent lot difference in immunological reagent is considerably larger than that of chemistry reagent and a shift of the point on the control chart is not adequate to assess the reliability of the patient data. Therefore, an evaluation method of the between reagent lot difference is described. General procedures of precision control are not described here because the procedures are well known.
尽管酶免疫测定（EIA）质量控制的基本概念与常规化学分析的质量控制相同，但与化学方法相比，包括酶免疫测定在内的免疫分析方法根据方法不同具有一些特定特征。因此，除了常规的质量控制方法外，还需要添加一些质量控制技术来控制该方法产生的变量。在EIA的准确性控制中，标准物质、试剂和分析设备将是主要误差来源。文中描述了准确性控制中需要考虑的要点。在EIA的精密度控制中，批间精密度通常大于批内精密度。考虑到这些特点，文中描述了适用于免疫方法的均值-Rs-R控制图法和Z-V控制图法。在EIA中，以可检测性和检测限表示的分析灵敏度非常重要。文中详细描述了确定检测限的程序。免疫试剂的不同试剂批次间差异比化学试剂大得多，控制图上点的偏移不足以评估患者数据的可靠性。因此，文中描述了一种评估试剂批次间差异的方法。由于精密度控制的一般程序广为人知，此处不再赘述。
