Jung K, Grützmann K D, Egger E, Fechner C
Clin Chim Acta. 1977 Sep 15;79(3):515-26. doi: 10.1016/0009-8981(77)90171-1.
Details of a systematic approach to suitability testing of commercial control sera are given for substrate optimized L-aspartate aminotransferase and L-alanine aminotransferase methods at 37 degrees C. Their acceptability for control purposes of standardized methods depends on: (1) the range of control values in relation to borderline values, (2) stability, (3) aspect, clarity, (4) NADH consumption in preincubation time, (5) blank activities, (6) kinetic data as half saturation constants and saturation curves, (7) influence of effectors, (8) isoenzyme pattern. These evaluation criteria are proposed for suitability testing. The term "representativeness" should be introduced as a special criterion for main characteristics of control materials. The authors want to point out the close connection with standardization of methods.
给出了在37摄氏度下针对底物优化的L-天冬氨酸转氨酶和L-丙氨酸转氨酶方法进行商业对照血清适用性测试的系统方法细节。它们对于标准化方法的对照目的的可接受性取决于：(1) 对照值相对于临界值的范围，(2) 稳定性，(3) 外观、清晰度，(4) 预孵育时间内的NADH消耗，(5) 空白活性，(6) 作为半饱和常数和饱和曲线的动力学数据，(7) 效应物的影响，(8) 同工酶模式。这些评估标准被提议用于适用性测试。术语“代表性”应作为对照材料主要特性的一个特殊标准引入。作者想指出与方法标准化的密切联系。
