ObjectiveTo provide a reference for the establishment and appliance of enzyme reference measurement of CK in China by comparing and analyzing the RELA results of CK in IFCC from 2006-2008. Methods The RELA samples of CK were measured according to the reference procedure for the measurement of catalytic activity concentration of CK (37 ℃) ,which had been published by IFCC. The EP5A2 protocol was used for evaluation of the imprecision and ERM was used for verification of the trueness. Results In RELA 2006, the result of sample A was (9. 896 ±0. 112) μkat/L, and the result of sample B was (4.953 ±0. 120) μkat/L. In RELA 2007, the result of sample A was (2.684 ±0.054)μkat/L, and the result of sample B was (8.798 μ0. 101) μkat/L. In RELA 2008, the result of sample A was (10. 523 ±0. 149) μkat/L,and the result of sample B was (10. 551 ±0. 141) μkat/L. The precision of the CK reference method in the year 2006 to 2008 was 0. 92%, 0. 86% and 0. 88% respectively, each of them is less than 1% and the results of ERMs were consistent with the certified value(1. 68 ± 0. 07)μkat/L,which verify the imprecision and accuracy of the reference method. Conclusions All of the results in the continuous three years were in the range of equivalence limits suggested by IFCC. The CK reference method suggested by IFCC has been established and it is getting better.%目的 对2006-2008年3年来参加IFCC组织的参考实验室RELA的CK的测定结果 进行比较和分析,为我国CK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CK国际样本,不精密度评价按美国CLSI的EP5-A2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 CK值为(9.896±0.112)μkat/L,样本B为(4.953±0.120)μkat/L;2007年测定结果 ,样本A为(2.684 ±0.054)μkat/L,样本B为(8.798 ±0.101)μkat/L;2008年测定结果 ,样本A为(10.523±0.149)μkat/L,样本B为(10.551±0.141)μkat/L.2006-2008年CK参考方法 的不精密度分别为0.92%、0.86%、0.88%,均＜1%,ERM测定均值在"靶值±不确定度[(1.68±0.07)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 连续3年的CK国际样本测定结果 均在IFCC公布的置信区间(limit of equivalence)±5%范围内,CK的IFCC参考方法 已经建立并且日趋成熟.
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