首页> 中文期刊> 《检验医学》 >γ-谷氨酰基转移酶国际室间比对计划结果分析

γ-谷氨酰基转移酶国际室间比对计划结果分析

         

摘要

Objective To compare and analyze the RELA [ International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) external quality assessment scheme for reference laboratories in laboratorg medicine ] results of gamma-glutamyltransferase (GGT) from the IFCC 2006-2008 in order to provide the reference for the establishment and application of GGT reference method. Methods The GGT levels of RELA samples were measured according to the standard operation procedure (SOP) (37 ℃ ) published by IFCC. The precision was evaluated according to the EP5-A2 document from National Committee for Clinical Laboratory Standards (NCCLS), and the accuracy was evaluated by European reference materials (ERM). Results In RELA 2006, the result of sample A was (1.829 ±0.021) μkat/L, and the result of sample B was (3.331 ±0.019) μkat/L. In RELA 2007, the result of sample A was ( 1. 533 ± 0.017 ) μkat/L, and the result of sample B was ( 3. 840 ± O. 035) μkat/L, In RELA 2008, the result of sample A was ( 3. 392 ± O. 024 ) μkat/L, and the result of sample B was ( 3. 058 ± 0. 024) μkat/L. The precisions of the year 2006, 2007 and 2008 were 1.29%, 0.44% and 0.65% respectively, and the results of ERM agreed with the certified value [ target value ± precision value: ( 1.90 ± 0.04) μkat/L], which verified the precision and accuracy of the reference method. Conclusions All of the results of the 3 years agree to the confidence interval by IFCC. The GGT reference method has been established.%目的 对2006~2008年参加国际临床化学联合会(IFCC)组织的参考实验室国际比对计划(RELA)的γ-谷氨酰基转移酶(GGT)测定结果进行比较和分析,为GGT参考方法的建立和应用提供借鉴.方法 按照IFCC公布的酶学活性测定(37℃)参考方法的标准操作程序(SOP)测定GGT国际样本,不精密度评价按美国临床实验室标准化委员会(NCCIS)EP5-A2文件进行,准确度评价采用国际有证参考物质(ERM).结果 2006年测定结果 样本A为(1.829±0.021)μkat/L,样本B为(3.331±0.019)μkat/L;2007年测定结果 样本A为(1.533±0.017)μkat/L,样本B为(3.840±0.035)μkat/L;2008年测定结果 样本A为(3.392±0.024)μkat/L,样本B为(3.058±0.024)μkat/L.2006~2008年GGT参考方法的不精密度分别为1.29%、0.44%、0.65%,ERM测定均值在"靶值±不确定度"[(1.90±0.04)μkat/L]范围内,初步验证了参考方法的不精密度和准确度.结论 2006~2008年RELA样本GG7,测定结果均在IFCC公布的可信区间内,GGT的IFCC参考方法已经建立.

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