两种生化试剂测定GGT的方法对比及偏差评估  

Method comparison and bias estimation for serum r-glutamyl transferase assays with two kinds of reagent

作　　者：贾雄飞[1] 王慧萱[1] 陈忠明[1] 滕毅[1] 夏正武[1] 李忠涛[1] 刘凌[1] 

机构地区：[1]中国人民解放军成都军区昆明总医院检验科,云南昆明650032

出　　处：《中国实验诊断学》2010年第3期334-336,共3页Chinese Journal of Laboratory Diagnosis

基　　金：国家高技术研究发展计划(863计划)资助项目(2006AA020901)

摘　　要：目的在全自动生化分析仪上使用国产中生北控生物科技公司和瑞士ROCHE(罗氏)公司试剂共同检测临床患者血清r-谷氨酰转移酶(r-glutamyl transferase,GGT)。比对国产试剂与国际试剂的准确性和可靠性。方法依据原美国临床和实验室标准化委员协会(CLSI)EP9-A文件要求,每天随机抽取临床样本8份,分别用两种试剂共同测定5 d,以中生北控试剂为实验方法,瑞士ROCHE试剂为对比方法,共测定40份新鲜的患者血清GGT,然后对结果进行分析。结果经统计学分析,两种试剂测定的血清GGT结果的相关系数为0.999 3,无方法间的离群点,测定结果的偏差在允许误差范围内。结论经过方法对比及偏差评估确定在本实验室,用中生公司的GGT试剂与罗氏公司生产的GGT试剂盒对比,符合临床要求。Objective To explore the feasibility of the patient＇ s serum r-glutamyl transferase by using the reagents of Zhong- sheng and ROCHE in the automatic biochemical analyzer. Methods According to the file of NCCLS-EP9-A of America. Every day, 8 patients samples were analyzed with two kinds of reagent separately for 5 days and record the test results in 5 days together,then evaluate the bias estimation of the different reagents, Reagents of Zhongsheng for the experimental method, roche reagent for the comparison. Results The related coefficient of using two kinds of phosphor reagent was 0. 999 3 without outlier between methods, the bias of results were accepted in the range of the allowable error. Conclusion It is feasible that Zhongsheng reagent replacet ROCHE, in our laboratory after method comparison and bias estimation.

关 键 词：R-谷氨酰转移酶 方法比对 偏差评估 

分 类 号：R446.1[医药卫生—诊断学]