酶学参考实验室室间质量评价技术方案的建立

Established Technical Solutions of the Enzymology Reference Laboratory External Quality Assessment

目的建立酶学参考实验室室间质量评价技术方案，使之符合酶学参考实验室质量要求。方法以γ-谷氨酰氨转移酶（GOT）和乳酸脱氢酶（LDH）为例，按IFCC要求建立该室的酶学参考实验室技术方案，样本的测定采用JCTLM认可的IFCC37℃条件下酶催化活性测量参考方法，以均值和不确定度报告结果。结果返回后，撰写年度室间质量评价总结报告。以酶学参考实验室通过标准评价该室建立的酶学参考实验室室间质量评价技术方案。结果以该室建立的酶学参考实验室室间质量评价技术方案参加GGT和LDH质量评价。检测卫生部临检中心发放的用于监测国家酶学参考实验室的质控样本（GGT样本号是2008101和2008102；LDH样本号是2008103和2008104）。2008年GGT测定结果：该室2008101号样本为：76．27U／L，不确定度1．16U／L；2008102号样本为：225．47U／L，不确定度5．32U／L。国家酶学参考实验室（除掉离群值）：2008101号样本为：75．30U／L；2008102号样本为：221．49U／L。2008年LDH测定结果：该室2008103号样本为：225．67U／L，不确定度5．62U／L；2008104号样本为：297．37U／L，不确定度8．94U／L。国家酶学参考实验室（除掉离群值），2008103号样本为：227．90U／L；2008104号样本为：294.03U／L。国家评价标准为均值±5．25％为合格。结论该室建立的酶学参考实验室室间质量评价技术方案符合国家参考实验室质量要求。

Objective To establish technical solutions of the enzymology reference laboratory external quality assessment and to make it consistent with enzyme reference laboratory quality requirements. Methods Example for γ-glutamyl transferase （GGT） and lactate dehydrogenase （LDH）, established technical solutions of the enzymology reference laboratory by IFCC reference procedures. Methods of detected samples were approved by IFCC 37℃ and reported the results using mean and uncertainty. The results returned ,wrote an annual external quality assessment summary report. Evaluated enzyme reference laboratories by enzyme reference laboratory external quality assessment technology programs. Results GGT and LDH quality evaluation program. The sample was 2008 external quality assessment：GGT this lab：sample 2008101 was 76.27 U/L,and uncertainty was 1.16 U/L;sample 2008102 was 225.47 U/L and uncertainty was 5.32 U/L. National enzyme reference laboratory （to get rid of outliers） ：sample 2008101 was 75.30 U/L;sample 2008102 was 221.49 U/L. LDH this lab：sample 2008103 was 225.67 U/L and uncertainty was 5.62 U/L;sample 2008104 was 297.37 U/L and uncertainty was 8.94 U/L. National enzyme reference laboratory （to get rid of outliers）：sample 2008103 was 227.90 U/L;sample 2008104 was 294. 03 U/L. National evaluation standards was mean ±5. 25%. Conclusion This enzyme reference laboratory established EQA technical solutions in line with national reference laboratory quality requirements.