摘要
目的：探讨东芝TBA-120FR全自动生化分析仪线性扩展功能（即FLEX模式）检测高浓度酶样本的性能。方法分别采用FLEX模式及稀释模式检测丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）高浓度样本（ALT：2185～5240 U/L，AST：2520～6625 U/L），计算FLEX模式与稀释模式检测结果的相对偏差，并将2种模式检测的结果进行线性回归分析。结果FLEX模式与稀释模式检测的ALT及AST结果相对偏差均〈6%，符合卫生行业标准WS/T403-2012要求。2种模式的测定结果经线性回归分析，具有良好的相关性[ALT：决定系数（R2）=0.999，P〈0.001；AST：R2=0.999，P〈0.001]。将ALT、AST医学决定水平的高浓度值代入回归方程，得出其在医学决定水平的相对偏差为1.9%和2.2%，低于1/2美国临床实验室改进修正法案（CLIA88）允许总误差，为临床可接受水平。结论FLEX模式扩展了酶活性检测的可报告范围，保证了检验结果的准确、快速，提高了工作效率，具有重要的应用价值。
Objective To investigate the performance of FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer in the determination of high-concentration enzyme samples. Methods The high-concentration alanine aminotransferase （ALT）and aspartate aminotransferase（AST）samples（ALT：2 185-5 240 U/L,AST：2 520-6 625 U/L）were determined by FLEX mode and manual dilution mode,the relative deviation of 2 modes was calculated,and the 2 modes were analyzed by linear regression analysis. Results The relative deviation was 〉6%between FLEX mode and manual dilution mode,which met the health industry standard WS/T403-2012 requirements. The linear regression analysis showed that the 2 modes had a good correlation [ALT：coefficient of determination （R2）=0.999,P〈0.001;AST：R2=0.999,P〈0.001]. The medical decision levels of high-concentration ALT and AST generated into regression equation,and the relative deviations were 1.9% and 2.2% for calculating medical decision levels. Less than half of allowable total error from the Clinical Laboratory Improvement Amendments in 1988（CLIA88）was used as clinical acceptable level. Conclusions The reportable range of enzyme activity determination is expanded by FLEX mode,which can ensure obtaining results accurately and rapidly and improve work efficiency, and FLEX mode is of significance.
出处
《检验医学》
CAS
2016年第8期684-687,共4页
Laboratory Medicine
