国际临床化学联合会酶学测定参考方法实验室网络的初步建立

Performance of IFCC enzyme reference method laboratory network in China

目的总结我国实验室运行国际临床化学联合会（IFCC）酶学测定参考方法情况和参加IFCC参考实验室室间质评（RELA）结果，了解我国酶学参考测量水平。方法目前国内有8家实验室运行全部或部分IFCC酶学参考方法。各实验室按IFCC参考方法建立测量程序，评价各自程序的精密度与准确性，精密度评价按美国临床和实验室标准协会（CLSI）EP-5进行，准确度评价采用国际有证参考物质。7家实验室参加2006年RELA。结果各实验室目前能达到的批内变异系数（CV）均在1．5％以内，批间精密度在2％以内。部分实验室进行了有证参考物质分析，测定结果偏倚在给定的不确定度范围内。我国酶学实验室在2006年RELA中具有与除外组相似的室间CV，只是样本A乳酸脱氢酶（LDH）及样本BALT的室间CV较大，但剔除可能离群值后室间CV与除外组相似。结论中国酶学实验室经过5年的发展，现在无论从硬件配置还是技术力量上均已接近国外同类实验室，我国临床酶学参考实验室网络已初步建立。

Objective To review the performance of the IFCC enzyme reference methods in China laboratories and to evaluate the competence of enzyme reference measurement in China. Methods The International Federation of Clinical Chemistry and laboratory Medicine （IFCC） enzyme reference methods were performed in 8 China laboratories. Reference procedures were developed by each laboratory and the performances were evaluated. The Clinical and Laboratory Stodards Institute （CLSI） EP-5 protocol was used for the evaluation of precision and certified reference materials （ CRMs ） were used for the verification of trueness. Seven of the 8 laboratories participated in the 2006 IFCC external quality assessment program for reference laboratories （RELA） for the assessment of the measurement performance. Results Within-run CVs of less than 1,5% and between-run CVs of less than 2% were achieved by all the China laboratories, Results on CRMs by some of the laboratories agreed with the certified value within the stated uncertainty, In the 2006 RELA, the averages and the interlaboratory CVs of the China laboratories were similar to those of international laboratories, Conclusion A preliminary enzyme reference method laboratory network has been established in China.