AST和ALT参考方法在室间质评靶值中的应用  

Application of AST and ALT reference method in assessing the target values from EQA

作　　者：罗晓旭 秦大鹏 梁转霞 申彬 杜怡青 杨泽华[2] LUO Xiaoxu;QIN Dapeng;LIANG Zhuanxia;SHEN Bin;DU Yiqing;YANG Zehua(Department of Laboratory Medicine,First Hospital of Shanxi Medical University,Taiyuan 030001,China;Department of Laboratory Medicine,Sixth Hospital of Shanxi Me-dical University)

机构地区：[1]山西医科大学第一医院检验科,太原030001 [2]山西医科大学第六医院检验科

出　　处：《山西医科大学学报》2019年第10期1466-1470,共5页Journal of Shanxi Medical University

摘　　要：目的探讨天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)的参考方法测定值与室间质评(EQA)公议靶值二者的相关性,为EQA公议靶值在评价临床实验室性能中的正确性提供依据。方法采用AST和ALT参考方法分别对2017年山西省临床检验中心的10个样本及2019年卫生部临床检验中心(NCCL)的5个样本的AST和ALT分别进行测定,将所得值与各自EQA公议靶值进行相关分析、偏倚评估,并根据美国临床实验室改进修正案’88(CLIA’88)规定的1/2允许总误差(TEa)为标准,判断结果是否通过。结果AST和ALT的EQA公议靶值与参考方法测定值均具有良好的相关性,2017年和2019年室间质评样本的AST、ALT项目的回归方程分别为Y AST2017=1.010 6X+1.1078,R 2=0.998 8;Y ALT2017=1.060 2X-0.611 7,R 2=0.998 8;Y AST2019=1.021 9X-0.782 8,R 2=0.999 9;Y ALT2019=1.022 4X-0.682 3,R 2=0.999 1。所有批号的相对偏倚均在CLIA’88规定的1/2 TEa内。结论EQA公议靶值现阶段在一定程度上可用于我国EQA计划。Objective To explore the comparability between the target values of EQA and values determined by reference method for asparate aminotransferase(AST)and alanine aminotransferase(ALT),and provide the basis for the clinical validity of target values of EQA in external qualitative assessment(EQA).Methods Ten EQA samples from Shanxi Center for Clinical Laboratory in 2017 and five EQA samples from National Center for Clinical Laboratories(NCCL)in 2019 were measured by reference method,and then the determined results were compared with the target values of EQA for the correlation analysis and bias evaluation according to the 1/2 total allowable error(TEa)of Clinical Laboratory Improvement Amendments 88(CLIA’88).Results There was a good correlation between the target values of EQA and the determined values by reference method for AST and ALT,and the correlation equation was Y AST2017=1.010 6X+1.107 8(R 2=0.998 8),Y ALT2017=1.060 2X-0.611 7(R 2=0.998 8),Y AST2019=1.021 9X-0.782 8(R 2=0.999 9)and Y ALT2019=1.022 4X-0.682 3(R 2=0.999 1),respectively.The relative bias of all batches were not exceeding 1/2 TEa of CLIA’88.Conclusion The target values of EQA for AST and ALT can be accepted to some extent in China’s EQA program.

关 键 词：丙氨酸氨基转移酶 天门冬氨酸氨基转移酶 参考方法 室间质量评价 

分 类 号：R446[医药卫生—诊断学]