摘要
目的调查我国4家参考实验室应用国际临床化学联合会（IFCC）推荐加和不加磷酸吡哆醛参考方法测定ALT和AST的室内和室间变异，为设定合适的室内和室间变异的范围提供依据。方法建立加和不加磷酸吡哆醛的IFCC方法，用均一性良好的5个浓度冰冻混合人血清作为比对材料，观察各实验室测量比对样本的室内和室间变异，并与2006年和2007年参考实验室外部质量评价计划（RALE）的结果做比较。同时分析加与不加磷酸吡哆醛时AST、ALT测定值及AST／ALT比值的差异。结果本次比对的室间变异大于室内变异，仅个别实验室在个别结果出现室内变异大于室间变异的情况。室内变异不大于RELA比对室内变异的变化，室间变异亦明显小于后者。加磷酸吡哆醛法的ALT和AST测量值均比未加法高，两种方法得到的AST／ALT比值具有显著性差异。结论建议酶学参考实验室ALT、AST测定室内变异分别小于2．72％、2．58％；使用冰冻血清作比对材料时，二者的室间变异小于3．5％；冰冻干燥品作比对材料时，二者的室间变异小于4．5％。应观察不同个体样本加和不加磷酸吡哆醛转氨酶测定值及其比值的变化在疾病诊断与预后评估中的临床意义。
Objective To investigate the intralaboratory and interlaboratory variations of measurements for ALT and AST among four domestic reference laboratories. Methods The International Federation of Clinical Chemistry and Laboratory Medicine （IFCC） reference procedures and IFCC procedures without pyridoxal 5-phosphate （PLP） were performed in the reference laboratories. Intralaboratory and interlaboratory CVs were compared with those in 2006 and 2007 IFCC External Quality Assessment Scheme for Reference Laboratories （RELA）. Meanwhile, deviations of results for ALT, AST and AST/ALT between two methods were calculated. Results Interlaboratory CVs were generally higher than intralaboratory CVs. Interlaboratory CVs among the 41 laboratories were lower than those in RELA. Results of ALT and AST using method with PLP were higher than those using method without PLP. Difference of AST/ALT ratio between the two methods was significant. Conclusions For reference measurement of the 2 enzymes, interlaboratory CVs of 〈 3.5 are achievable on frozen serum materials. Measurements on lyophilized materials may have higher CVs. Further studies are needed for the investigation of the differences between results obtained in the absence and presence of PLP.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2009年第5期499-503,共5页
Chinese Journal of Laboratory Medicine
基金
国家十一五科技支撑计划资助项目（2007BA105B09）
国家高技术研究发展计划（863计划）资助项目（2006AA020909）通信作者：徐国宾,电子信箱：bdyyjyk@vip.sina.com
关键词
丙氨酸转氨酶
天冬氨酸氨基转移酶类
磷酸吡哆醛
临床酶试验
参考标准
评价研究
Alanine transaminase
Apartate aminotransferase
Pyridoxal phosphate
Clinical enzyme tests
Reference standards
Evaluation studies
