Assessment of the trueness and inter-laboratory precision of routine uric acid assays using 4 frozen pooled serum samples measured by the Japan Society of Clinical Chemistry's HPLC method.
Assessment of the trueness and inter-laboratory precision of routine uric acid assays using 4 frozen pooled serum samples measured by the Japan Society of Clinical Chemistry's HPLC method.
复制标题
DOI：
10.3343/alm.2014.34.2.104
复制
发表时间：
2014-03
影响因子：
4.9
通讯作者：
Xu G
中科院分区：
文献类型：
--
作者：
Jiang Y;Liu O;Xu G
需要参考程序来评价尿酸（UA）常规分析系统的准确度。UA的室间质量评价（EQA）仅在中国进行了质量控制，结果尚未公布。本研究旨在研究使用候选参考方法在常规分析系统中UA测量的真实性和实验室间精密度。我们进行了日本临床化学学会（JSCC）推荐的HPLC方法。接下来，我们评估了它的分析性能并验证了它的正确性。根据生物学相关质量目标，使用HPLC法测定的4份冷冻合并血清样本，评估了4个常规分析系统（每个系统5台仪器，n=20）对UA的性能。批内、批间、日间和总变异系数分别小于0.3%、0.4%、1.8%和2.6%。UA测量结果与标准参考物质（SRM）909 b、参考实验室第六次环试（RELA-2008）标本和国家一级参考物质的目标值一致。4份冷冻合并血清样本均质、稳定且可互换。所有常规系统都达到了预期的性能目标（总误差<11.9%）。我们成功地复制了JSCC的HPLC方法，该方法简单，专属性强，精密度高，准确度好。我们推荐此方法作为人血清中UA测定的参考方法。四种常规分析系统的尿酸测定结果具有较好的一致性。
Reference procedures are required for evaluating the accuracy of routine analytical systems for uric acid (UA). External quality assessment (EQA) for UA has only been conducted with quality controls in China, and the results have not been published. This study was designed to investigate both the trueness and inter-laboratory precision of UA measurements among routine analytical systems using a candidate reference method. We performed the HPLC method recommended by the Japan Society of Clinical Chemistry (JSCC). Next, we evaluated its analytical performance and validated its trueness. The performance of 4 routine analytical systems (5 instruments per system, n=20) for UA was assessed by using 4 frozen pooled serum samples measured by the HPLC method according to biologically relevant quality goals. Within-run, between-run, inter-day, and total CV of the method were less than 0.3%, 0.4%, 1.8%, and 2.6%, respectively. The UA measurements were consistent with the target values of standard reference material (SRM) 909b, the sixth ring trial for Reference Laboratories (RELA-2008) specimen, and national primary reference materials. The 4 frozen pooled serum samples were homogeneous, stable, and commutable. All routine systems achieved the desirable performance goal (total error <11.9%). We successfully reproduced the JSCC's HPLC method, which was simple, specific, precise, and accurate. We recommend this method as a reference method for UA measurement in human serum. Four routine analytical systems for UA measurement had acceptable traceability, and their UA results showed good concordance.
登录
查看更多内容
DOI：
10.1016/j.jchromb.2007.07.035
发表时间：
2007-10-01
影响因子：
3
作者：
Dai, Xinhua;Fang, Xiang;Xu, Bei
通讯作者：
Xu, Bei
影响因子：
19.6
作者：
WILSON, DM;GOLDSTEIN, NP
通讯作者：
GOLDSTEIN, NP
影响因子：
4.6
作者：
AuBuchon, J. P.;de Wildt-Eggen, J.;Dumont, L. J.
通讯作者：
Dumont, L. J.
影响因子：
7.4
作者：
ELLERBE, P;COHEN, A;WHITE, E
通讯作者：
WHITE, E
影响因子：
1.5
作者：
Lanaspa, Miguel A.;Sautin, Yuri Y.;Johnson, Richard J.
通讯作者：
Johnson, Richard J.