检验医学 ›› 2025, Vol. 40 ›› Issue (7): 703-707.DOI: 10.3969/j.issn.1673-8640.2025.07.012

• 论著 • 上一篇    下一篇

不同品牌线粒体天门冬氨酸氨基转移酶试剂检测结果一致性分析

林斐然, 欧元祝(), 虞啸炫, 葛丹红, 龚敬凯, 赵品琪, 王雯琴   

  1. 上海市临床检验中心,上海 200126
  • 收稿日期:2024-02-28 修回日期:2024-11-21 出版日期:2025-07-30 发布日期:2025-07-28
  • 通讯作者: 欧元祝,E-mail:ouyuanzhu@sccl.org.cn
  • 作者简介:林斐然,女,1990年生,学士,主管技师,主要从事临床化学检验质量控制工作。

Consistency of mitochondrial aspartate aminotransferase reagent test results from different brands

LIN Feiran, OU Yuanzhu(), YU Xiaoxuan, GE Danhong, GONG Jingkai, ZHAO Pinqi, WANG Wenqin   

  1. Shanghai Center for Clinical Laboratory,Shanghai 200126,China
  • Received:2024-02-28 Revised:2024-11-21 Online:2025-07-30 Published:2025-07-28

摘要:

目的 比较7个品牌线粒体天门冬氨酸氨基转移酶(m-AST)试剂检测结果,分析不同品牌m-AST试剂检测结果一致性的影响因素,为上海地区m-AST检测结果互认提供参考。方法 采用7个品牌m-AST、天门冬氨酸氨基转移酶(AST)试剂与日立3500全自动生化分析仪组成7个m-AST检测系统和7个AST检测系统,检测30例血清样本。7个m-AST系统两两配对组成21个组。统计21个组的相关系数,采用Passing-Bablok回归分析计算21个组的斜率、截距;采用Bland-Altman分析计算相对平均偏差,并计算14个检测系统检测同一血清样本m-AST、AST值的变异系数(CV)及其均值,以及7个m-AST检测系统与对应的AST检测系统检测结果的比值。结果 21个组中,有20个组检测结果一致性较差。7个m-AST检测系统和7个AST检测系统检测同一血清样本的平均CV分别为39.53%和6.17%。各检测系统的m-AST和AST比值差异均较明显,除1个m-AST检测系统与对应的AST检测系统检测结果在各浓度水平的比值波动较为恒定外,其他系统检测结果在各浓度水平的比值均有较大幅度波动,但波动趋势一致。结论 不同品牌试剂检测m-AST结果差异显著,尚缺乏可比性,原因可能为不同品牌试剂细胞质天门冬氨酸氨基转移酶(c-AST)抑制率的差异。

关键词: 线粒体天门冬氨酸氨基转移酶, 天门冬氨酸氨基转移酶, 一致性, 可比性

Abstract:

Objective By comparing the determination results of mitochondrial aspartate aminotransferase (m-AST) reagents of 7 brands,the influencing factors of the harmonization of serum samples determined by different brands of m-AST reagents have been discussed in order to provide a reference for the harmonization of m-AST determination results in Shanghai. Methods Seven m-AST determination systems and 7 aspartate aminotransferase(AST)determination systems were composed of m-AST and AST determination reagents of 7 brands and Hitachi 3500 automatic analyzer. Seven m-AST and AST determination systems were used to determine 30 serum samples. The 7 m-AST systems were paired in pairs to form 21 comparison combinations,and the correlation coefficients of 21 groups were calculated. Passing-Bablok regression analysis was used to analyze the slope and intercept of the 21 groups,and Bland-Altman analysis was used to analyze the relative average deviation of the 21 groups. The coefficient of variation(CV)and mean CV of m-AST and AST results of the same serum samples determined by 7 m-AST and AST determination systems were calculated,respectively,as well as the ratio of the determination results of 7 m-AST determination systems to the corresponding AST determination systems. Results Among the 21 m-AST system comparison combinations,except for one group,the harmonization of the results in the remaining 20 groups was poor. The average CV of the same clinical sample determined by 7 m-AST determination systems was 39.53%,and the average CV of the same clinical sample determined by 7 AST determination systems was 6.17%. The ratio of m-AST to AST was different from that of each determination system,except for one determination system and the corresponding AST determination system,and the ratio of the determination results of the other systems at each concentration level fluctuated significantly,but the fluctuation trend was consistent. Conclusions There are significant differences in the results of m-AST,which lacks comparability. The reason for the lack of comparability of m-AST results is mainly the difference in the inhibition rate of cytoplasmic aspartate aminotransferase (c-AST) among various reagents.

Key words: Mitochondrial aspartate aminotransferase, Aspartate aminotransferase, Harmonization, Comparability

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