六种临床诊断酶学测定参考方法的应用及国际比对结果分析  

Application of reference methods suggested by IFCC and analysis of the 2006 ring trial results

作　　者：王涛[1] 齐丽丽[2] 刘海燕[1] 田真[1] 何振坤[1] 李淑葵[2] 但万春[1] 徐国宾[2] 

机构地区：[1]中生北控生物科技股份有限公司,北京102200 [2]北京大学第一医院检验科

出　　处：《中华检验医学杂志》2008年第3期264-269,共6页Chinese Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划（863计划）资助项目（2006AA020909）;“十一五”课题（2007BA105809）

摘　　要：目的应用国际临床化学联合会（IFCC）公布的参考方法对血清丙氨酸氨基转移酶（ALT）、（天）门冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）、肌酸激酶（CK）、γ-谷氨酰基转移酶（GGT）及淀粉酶（AMY）6个酶进行测定，并通过参加参考实验室国际比对计划评估参考方法的准确性。方法按照IFCC有关酶学活性测定（37℃）参考方法的标准操作程序（SOP），分别使用PE和Agilent的两套测定系统进行6个酶的测定。通过测定质控血清监测两套测定系统的稳定状态、有证参考物（CRM）并参加酶学国际比对（ring trial），验证参考方法的准确性。结果两套系统测定室内质控血清的测值稳定，6种酶天间测定变异系数为0．5％～1．9％；测定结果一致，两者结果偏移小于2．1％；CRM测定结果在允许的范围内，初步验证了参考方法的准确性；高低两个浓度样本，两个独立系统的国际比对结果中有4个酶（ALT、AST、GGT、AMY）的测定值位于所有参考实验室测定的^-x±s范围内，LDH与CK测值位于^-x±2s之间；用稳健统计学方法评价，除了LDH的样本A测值属于离散值以外，其他5个酶ALT、AST、CK、GGT、AMY及LDH样本B的比对结果未发现离群。结论应用IFCC参考方法采用两套测定系统对6个酶进行的测定结果稳定、准确，具有等效性。Objective To establish reference methods for the measurement of catalytic activity concentrations of enzymes at 37℃ which have been published by IFCC and evaluate accuracy of reference methods. Methods Six reference methods for the measurement of catalytic activity of enzymes were established with two sets of apparatus systems of PE and Agilent according to International Federation of Clinical Chemistry（IFCC） 37℃ reference procedures in two reference labs respectively. The commercial Roche calibrator c. f. a. s was used to monitor the precision of two reference labs as quality control material. Certified Reference Materials （CRMs） represented an efficient tool to assess the analytic performance for the verification of trueness and in two labs. The measurement accuracy of the assays for catalytic activity concentrations of 6 enzymes [ alanine aminotransferase （ ALT）, aspartate aminotransferase （ AST）, lactate dehydrogenase （LDH） , creatine kinase （CK） , gamma-glutamyltransferase （GGT） , amylase （AMY） ] was further verified and validated by international ring trial program. Results The within-laboratory variations of 6 enzymes in both of the reference lab were ranged from 0. 5% -1.9%. Their results showed fully agreement with deviation less than 2.1%. The value of CRM was in the tolerant limit and analytic accuracy was verified. The results of four enzymes （ ALT, AST, GGT, AMY） lay within ^-x ＋ s. However, the result of CK and LDH lay within ^-x ＋ 2s. Except sample A for the LDH testing, we did not find any deviation variable in the detection of other enzymes. Conclusions The reference methods for the measurement of catalytic activity of enzymes （ALT, AST, LDH, CK, GGT, AMY） at 37℃ in the two labs by use of two sets of apparatus systems of PE and Agilent have been established and these methods showed excellent stability and accuracy.

关 键 词：酶试验 实验室技术和方法 参考值 国际标准化比 

分 类 号：R686[医药卫生—骨科学]