Marcovina S M, Albers J J
Department of Medicine, University of Washington School of Medicine, Seattle 98104-2499.
Scand J Clin Lab Invest Suppl. 1990;198:58-65.
A correct approach to standardization, accuracy-based methods, and well-defined quality assurance programs is indispensable for the definition of international reference intervals of apo A-I and apo B. Variability in the immunochemical determination of apo A-I and apo B can be due to both preanalytical and analytical variations, and standardized laboratories should evaluate and minimize each source of error in determining the reference intervals. A key requirement to reduce the variation between measurement techniques is the use of a common protocol for the calibration of the different methods. The basis of a calibration system is the primary standard with the absolute mass accurately determined. The primary standard is indispensable in assigning an accurate target value to reference materials with a reference method in which the primary standard immunochemically reacts the same as the protein in plasma. The reference material, which must behave immunochemically the same as the patient's sample in all methods, is then used to assign a target value to the calibrator in each method and system. Following this procedure, all assay results can be traced back to the primary standard via the serum reference material. The development and distribution of reference and quality control materials, which do not exhibit matrix effects between methods, is fundamental for the standardization process.
正确采用标准化方法、基于准确性的方法以及定义明确的质量保证程序，对于确定载脂蛋白A-I和载脂蛋白B的国际参考区间必不可少。载脂蛋白A-I和载脂蛋白B免疫化学测定中的变异性可能源于分析前和分析过程中的变异，标准化实验室在确定参考区间时应评估并尽量减少每种误差来源。减少测量技术之间差异的一个关键要求是使用通用方案对不同方法进行校准。校准系统的基础是准确测定绝对质量的一级标准品。一级标准品对于用参考方法为参考物质赋予准确的目标值必不可少，在该参考方法中，一级标准品与血浆中的蛋白质具有相同的免疫化学反应。然后，在所有方法中必须与患者样本具有相同免疫化学行为的参考物质，被用于为每种方法和系统中的校准品赋予目标值。按照此程序，所有检测结果都可以通过血清参考物质追溯到一级标准品。开发和分发在不同方法之间不表现出基质效应的参考物质和质量控制物质，对于标准化过程至关重要。
