γ-谷氨酰基转移酶国际室间比对计划结果分析

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（NCCLS）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GGT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。

Analysis of the RELA results of gamma-glutamyltransferase reference method

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±0.035） μkat/L.In RELA 2008,the result of sample A was（3.392±0.024） 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.