Férard G, Edwards J, Kanno T, Lessinger J M, Moss D W, Schiele F, Tietz N W, Vassault A
Laboratoire de Biochimie Appliquée, Faculté de Pharmacie, Université Louis Pasteur, Illkirch, France.
Clin Biochem. 1998 Aug;31(6):495-500. doi: 10.1016/s0009-9120(98)00039-3.
The objective of this guideline is to improve standardization in clinical enzymology in order to improve intermethod comparability of patients' results.
The reference system, combination of the reference method and the reference material, is used to produce a reference value for a given catalytic activity. Sets of methods are formed of methods exhibiting the same analytical specificity. Materials intended to be used as enzyme calibrators are experimentally checked for their commutability.
The transfer of accuracy from the reference value to patients' results is dependent on methods (analytical specificity) and on materials (experimentally assessed commutability). The feasibility of this approach was demonstrated with materials of high level for several enzymes and for each of them for several routine methods.
Expected advantages of this approach in clinical enzymology are presented.
本指南的目的是提高临床酶学的标准化程度，以提高患者检测结果在不同方法间的可比性。
参考系统，即参考方法与参考物质的组合，用于生成给定催化活性的参考值。方法集由具有相同分析特异性的方法组成。对拟用作酶校准品的材料进行实验性可互换性检验。
从参考值到患者检测结果的准确性传递取决于方法（分析特异性）和材料（经实验评估的可互换性）。对于几种酶的高水平材料以及每种酶的几种常规方法，均证明了该方法的可行性。
阐述了该方法在临床酶学中的预期优势。
