Siekmann Lothar, Bonora Roberto, Burtis Carl A, Ceriotti Ferruccio, Clerc-Renaud Pascale, Férard Georges, Ferrero Carlo A, Forest Jean-Claude, Franck Paul F H, Gella F-Javier, Hoelzel Wieland, Jørgensen Poul Jørgen, Kanno Takashi, Kessner Art, Klauke Rainer, Kristiansen Nina, Lessinger Jean-Marc, Linsinger Thomas P J, Misaki Hideo, Mueller Mathias M, Panteghini Mauro, Pauwels Jean, Schiele Françoise, Schimmel Heinz G, Vialle Arlette, Weidemann Gerhard, Schumann Gerhard
Institut für Klinische Biochemie, Universität Bonn, Germany.
Clin Chem Lab Med. 2002 Jul;40(7):739-45. doi: 10.1515/CCLM.2002.127.
This paper is the seventh in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C and the certification of reference preparations. Other parts deal with: Part 1. The Concept of Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes; Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase; Part 3. Reference Procedure for the Measurement of Catalytic Concentration of Lactate Dehydrogenase; Part 4. Reference Procedure for the Measurement of Catalytic Concentration of Alanine Aminotransferase; Part 5. Reference Procedure for the Measurement of Catalytic Concentration of Aspartate Aminotransferase; Part 6. Reference Procedure for the Measurement of Catalytic Concentration of Gamma-Glutamyltransferase. A document describing the determination of preliminary reference values is also in preparation. The certification of the catalytic activity concentrations as determined by the recently elaborated IFCC primary reference methods at 37 degrees C of four enzyme preparations, namely IRMM/IFCC 452 (gamma-glutamyltransferase), IRMM/IFCC 453 (lactate dehydrogenase 1), IRMM/IFCC 454 (alanine aminotransferase) and IRMM/IFCC 455 (creatine kinase) is described. Homogeneity data were derived from previous results. Stability was assessed using recently obtained data as well as data from previous stability studies. The collaborative study for value assignment was performed under a strict quality control scheme to ensure traceability to the primary reference method. Uncertainty of the materials was assessed in compliance with the Guide to the Expression of Uncertainty in Measurement. The certified values obtained at 37 degrees C are 1.90 microkat/l +/- 0.04 microkat/l (114.1 U/l +/- 2.4 U/l), for gamma-glutamyltransferase, 8.37 microkat/l +/- 0.12 microkat/l (502 U/l +/- 7 U/l), for lactate dehydrogenase 1, 3.09 microkat/l +/- 0.07 microkat/l (186 U/l +/- 4 U/l), for alanine aminotransferase and 1.68 microkat/l +/- 0.07 microkat/l (101 U/l +/- 4 U/l), for creatine kinase. The materials are intended for internal quality control as well as for the evaluation of test systems as required by recent European Union legislation. Furthermore, the materials can be used to transfer accuracy from a reference method to a routine procedure provided the procedures exhibit the same analytical specificity and the certified materials are commutable.
本文是关于37℃下酶催化活性浓度测量的参考程序及参考制剂认证系列文章中的第七篇。其他部分包括：第1部分。酶催化活性浓度测量参考程序的概念；第2部分。肌酸激酶催化浓度的测量参考程序；第3部分。乳酸脱氢酶催化浓度的测量参考程序；第4部分。丙氨酸氨基转移酶催化浓度的测量参考程序；第5部分。天冬氨酸氨基转移酶催化浓度的测量参考程序；第6部分。γ-谷氨酰转移酶催化浓度的测量参考程序。一份描述初步参考值测定的文件也在编写中。本文描述了通过最近精心制定的国际临床化学和检验医学联合会（IFCC）在37℃下的一级参考方法测定的四种酶制剂，即IRMM/IFCC 452（γ-谷氨酰转移酶）、IRMM/IFCC 453（乳酸脱氢酶1）、IRMM/IFCC 454（丙氨酸氨基转移酶）和IRMM/IFCC 455（肌酸激酶）催化活性浓度的认证情况。均匀性数据来自先前的结果。稳定性评估使用了最近获得的数据以及先前稳定性研究的数据。定值的协作研究在严格的质量控制方案下进行，以确保可追溯至一级参考方法。按照《测量不确定度表示指南》评估了材料的不确定度。在37℃下获得的认证值分别为：γ-谷氨酰转移酶1.90微kat/l±0.04微kat/l（114.1 U/l±2.4 U/l），乳酸脱氢酶1 8.37微kat/l±0.12微kat/l（502 U/l±7 U/l），丙氨酸氨基转移酶3.09微kat/l±0.07微kat/l（186 U/l±4 U/l），肌酸激酶1.68微kat/l±0.07微kat/l（101 U/l±4 U/l）。这些材料旨在用于内部质量控制以及按照欧盟近期法规要求对检测系统进行评估。此外，如果程序具有相同的分析特异性且认证材料具有互换性，这些材料可用于将准确性从参考方法传递至常规程序。
