改良尿酸酶法测量程序的性能评价

doi:10.3969/j.issn.1673-8640.2016.05.013

摘要/Abstract

摘要：

目的评价改良尿酸酶法测量程序性能,并评估其测量结果的不确定度。方法根据美国临床化学协会（AACC）公布的相关文件《血清尿酸候选参考方法优化和评价》,通过标准溶液重量法改善尿酸酶法测量程序的正确度,通过多次离心改善其精密度。评估该法改良后的正确度和精密度,并依据《测量不确定度表示指南》（GUM）评估其测量结果不确定度。结果尿酸标准曲线线性方程为Y=0.005 74X+0.003 09,R²=0.999 99。测量血清样本的相对标准偏差[变异系数（CV）]<1.0%;加标回收率为98.5%~101.5%,国际临床化学和检验医学联合会（IFCC）参考实验室外部质量评价计划（RELA）样本的测量结果与靶值的偏移均在±1.5%以内,相对标准不确定度<2.0%。结论改良尿酸酶法测量程序为血清尿酸常规测量系统的溯源提供了简易、有效的方法。

关键词: 尿酸, 血清, 尿酸酶法测量程序, 改良, 不确定度

Abstract:

Objective To evaluate the performance of improved uricase determination procedure and its uncertainty. Method According to A Candidate Reference Method for Uric Acid in Serum： Optimization and Evaluation which was published by American Association for Clinical Chemistry （AACC）,the accuracy was improved by standard solution gravimetric method. The precision was improved by multiple centrifugation. The accuracy and precision were evaluated,and the uncertainty was evaluated according to Guide to the Expression of Uncertainty in Measurement（GUM）. Results The standard curve linear equation of uric acid was Y=0.005 74X+0.003 09（R²=0.999 99）. The standard bias [coefficient of variation （CV）] was < 1.0%. The recovery ranged from 98.5% to 101.5%. The results of the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC）external quality assessment scheme for reference laboratories in laboratory medicine（RELA） samples fell in the range of target value,with bias ±1.5% and relative standard uncertainty< 2.0%. Conclusions The improved uricase determination procedure is successfully established. It may provide an effective way for routine determination traceability of serum uric acid.

Key words: Uric acid, Serum, Uricase determination procedure, Improvement, Uncertainty

中图分类号:

R446.1

韩根良, 徐锋, 徐玲, 沈敏, 郭慧涛, 张宏. 改良尿酸酶法测量程序的性能评价[J]. 检验医学, 2016, 31(5): 399-404.

HAN Genliang, XU Feng, XU Ling, SHEN Min, GUO Huitao, ZHANG Hong. Performance of improved uricase determination procedure and comparison with chromatography-mass spectrometry reference determination procedure[J]. Laboratory Medicine, 2016, 31(5): 399-404.

图/表 7

参考文献 11

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样本号	加标量（mg/L）	CV（%）	测定值（mg/L）	回收率（%）
1	0	0.56	33.67
1＇	20	0.63	53.41	98.7
2	0	0.48	63.24
2＇	40	0.24	103.76	101.3

样本号	加标量（mg/L）	CV（%）	测定值（mg/L）	回收率（%）
1	0	0.56	33.67
1＇	20	0.63	53.41	98.7
2	0	0.48	63.24
2＇	40	0.24	103.76	101.3

样本	A法（μmol/L）	偏移（%）	B法（μmol/L）	偏移（%）	参考值（μmol/L）
2012年RELA-A	544.3	0.95	547.5	1.35	539.2
2012年RELA-B	369.4	2.44	361.8	-0.05	360.6
2013年RELA-A	220.8	-3.32	231.5	1.37	228.4
2013年RELA-B	452.1	-0.10	453.6	0.22	452.6

样本	A法（μmol/L）	偏移（%）	B法（μmol/L）	偏移（%）	参考值（μmol/L）
2012年RELA-A	544.3	0.95	547.5	1.35	539.2
2012年RELA-B	369.4	2.44	361.8	-0.05	360.6
2013年RELA-A	220.8	-3.32	231.5	1.37	228.4
2013年RELA-B	452.1	-0.10	453.6	0.22	452.6

样本	A法（μmol/L）	相对标准偏差（%）	B法（μmol/L）	相对标准偏差（%）
2012年RELA-A	544.3	1.64	547.5	0.29
2012年RELA-B	369.4	1.15	361.8	0.71
2013年RELA-A	220.8	1.38	231.5	0.70
2013年RELA-B	452.1	1.16	453.6	0.28