不同试剂检测血清ALT结果的可比性及偏倚评估研究  

Comparability and Bias Evaluation of Serum ALT Levels Determined by Different Regents

作　　者：王惠萱[1] 贾雄飞[1] 滕毅[1] 余文婕[1] 朱光旭[1] 陈忠明[1] 夏正武[1] 李雪梅[1] 

机构地区：[1]解放军成都军区昆明总医院检验科,昆明650032

出　　处：《现代检验医学杂志》2009年第5期61-63,共3页Journal of Modern Laboratory Medicine

基　　金：国家高技术研究发展计划（863计划）编号：2006AA020901生物和医药领域：生物化学诊断试剂临床研究.

摘　　要：目的进行国产与进口ALT（丙氨酸氨基转移酶）诊断试剂对血清ALT测定结果的可比性及偏倚评估研究。方法按NCCLS EP9-A文件，每天选择高、中、低值临床血清标本8份，分别用中生试剂和罗氏试剂在日本0LYMPUS AU5421自动生化分析仪上测定ALT，以进口罗氏试剂为对照组，国产中生北控生物试剂为实验组。每份标本正序、倒序各测定1次，连测5d每天8份，共计40份标本。记录测定结果，做统计学分析。结果进口罗氏和国产中生两种ALT检验试荆对临床标本ALT的检测结果显示，方法内重复性检查DX′1≤4DX′，DY′≤4DY′，离群点检查Eij≤4^-E，Eij′≤4^-E′，线性回归R^2=0．9994、系统误差的估计值及其置信区间｜^BClow,^BChigh｜〈允许误差，系统误差符合临床要求。结论国产中生北控生物科技股份有限公司与进口罗氏诊断公司ALT诊断试剂分别对ALT进行测定时，两者间具有良好的可比性和相关性。Objective To evaluate the comparability and the bias of serum ALT results determined by domestic ALT diagnostic regent and imported diagnostic regent. Methods According to the NCCLS EP9-A document,eight serum samples with high-, middle- and low-ALT value were selected and the ALT concentrations determination were carried out by OLYMPUS AU5421 automatic biochemical analyzer with Zhongsheng ALT regent and Roche ALT regent respectively. The control group was Roche reagent,the experimental group was Zhongsheng reagent. The working group that were 40 patient samples was analyzed 5 operatingdays. The results were recorded and statistical analysis was performed. Results Two types of ALT diagnostic regent ,Roche and Zhongsheng on detection of clinical specimens ALT showed that ,methods with in the repetitive inspection DX′1≤4DX′,DY′≤4DY′ ,Outlier checks Eij≤4^-E,Eij′≤4^-E′ ,linear regression R^2= 0. 999 9,systematic errors estimates and confidence interval｜^BClow,^BChigh｜〈Permissible error and systematic errors in line with the clinical requirements. Conclusion Determination of the results of ALT determined by Domestic BIOSINO BIOT echnology Co. ALT diagnostic regent and Roche diagnostics corporation ALT diagnostic regent. There is a well comparability and positive correlation between the results resulted from two kinds of regents.

关 键 词：丙氨酸氨基转移酶 诊断试剂 可比性 偏倚评估 

分 类 号：R446.112[医药卫生—诊断学]