[1]费阳,王薇,何法霖,等.尿液定量生化检验项目室内质量控制变异系数调查与分析[J].现代检验医学杂志,2016,31(06):154-157.[doi:10.3969/j.issn.1671-7414.2016.06.046]
　FEI Yang,WANG Wei,HE Fa-lin,et al.Investigation and Analysis of the Coefficient of Variation of Internal Quality Control of Quantitative Urine Chemistry[J].Journal of Modern Laboratory Medicine,2016,31(06):154-157.[doi:10.3969/j.issn.1671-7414.2016.06.046]
点击复制

尿液定量生化检验项目室内质量控制变异系数调查与分析()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年06期
页码:
154-157
栏目:
质量控制·实验室管理
出版日期:
2016-12-20

文章信息/Info

Title:
Investigation and Analysis of the Coefficient of Variation of Internal Quality Control of Quantitative Urine Chemistry
作者:
费阳; 王薇; 何法霖; 钟堃; 王治国
北京医院 国家老年医学中心 卫生部临床检验中心/北京市临床检验工程技术研究中心,北京 100730
Author(s):
FEI Yang; WANG Wei; HE Fa-lin; ZHONG Kun; WANG Zhi-guo
National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital,National Center of Gerontology,Beijing 100730,China
关键词:
尿液定量生化;  室内质控;  变异系数;  质量规范
分类号:
R446.12
DOI:
10.3969/j.issn.1671-7414.2016.06.046
文献标志码:
A
摘要:
目的 评估尿液定量生化项目的室内质量控制(internal quality control,IQC)变异系数(coefficient of variation,CV)质量水平,并为实验室提供改进建议。方法 采用基于Web的室间质量评价 (external quality assessment,EQA)软件系统,收集参加全国尿液定量生化室间质评计划实验室2014年4月 的IQC数据。依据1/3室间质量评价限(total allowable error,TEa)和1/4TEa对IQC不精密度进行评价,计算 各实验室室内质控CV通过率。并按照是否使用配套检测系统分别统计。结果 研究中,上报尿液定量 生化项目各项目IQC相关数据的实验室数量从71到111不等。不同项目的当月和累积在控CV各不相同 ,其中K,Na和Cl的当月在控CV通过率高达100%,质量水平较高。Mg,Cre,Urea和mAlb则相对较低 (75.68%～93.51%),需要改进。不同实验室各项目使用仪器、试剂、校准品的配套情况各不相同,配套检测 系统累积CV中位数大于不配套检测系统。结论 不同实验室不同项目的CV情况各不相同,实 验室应该根据自身的情况选择适当的允许不精密度质量规范,将注意力更多地投入到CV不合格的项 目中,不断地提升自己,这样才能提供更加准确的结果和更加优质的服务。
Abstract:
Objective To evaluate the coefficient of variation(CV)of internal quality control(IQC)of quantitative urine chemistry and provide suggestions for improvement accordingly.Methods Web -based External Quality Assessment(EQA)system was used to collect IQC data of quantitative urine chemistry from EQA participant laboratories in April 2014.The precision of IQC were evaluated and percentages of laboratories meetingthe quality requirement were calculated according to 1/3 total allowable error(TEa)and 1/4TEa.And further analysis was done based on whether a complete set of measurement system was used.Results The number of participant laboratories in their survey ranged from 71 to 111.Current and accumulate CV varied among different analytes.The passing rates of current CVsfor K,Na and Cl were 100% while the passing rate of Mg,Cre,Urea and mAlb wererelatively low(75.68%～93.51%)which means improvement was needed for these analytes.The situation on whether a complete set of measurement system was usedvaried among laboratories.The cumulative median CV obtained by laboratoriesemploying a complete set of measurement system was lower than those not.Conclusion The imprecision of IQC of quantitative urine chemistry varied among different laboratories and different analytes.Laboratories should set proper quality requirements and make unremitting efforts to improve quality,especially for analytes which couldn't fulfill performance goals.Only inthis way,a more accurate result and high quality service can be obtained.

参考文献/References:

[1] 王宁蛟,姚文娟,魏源华.尿液生化分析对肾脏病变的诊断价值[J].检验医学与临床,2010,7(6):519- 521. Wang NJ,Yao WJ,Wei YH.Biochemical analysis of urine for diagnosisof kidney disease[J].Lab Med Clin,2010,7(6):519-521.
[2] 李熙建,谭同均,朱国文,等.胱抑素C与尿微量蛋白及尿酶联合检测在不同程度肾病中的应用价值[J].现 代检验医学杂志,2008,23(6):70-73. Li XJ,Tan TJ,Zhu GW,et al.Application of serum cystatin C,urinary microprotein and urinary enzyme in the degree of nephropathy[J].J Mod LabMed,2008,23(6):70-73.
[3] 赵海舰,张传宝,王 薇,等.脂类检验项目室内质控变异系数分析[J].中华检验医学杂志,2012,35 (12):1172-1175. Zhao HJ,Zhang CB,Wang W,et al.Analysis of the co-efficient of variation of internal quality control of lipid testing[J].Clin J Lab Med,2012,35(12):1172-1175.
[4] 刘晓春,周微雅,何 毅,等.广西三级医院临床化学互认检验项目室内质控变异系数调查与分析[J].现代 检验医学杂志,2013,28(5):147-150,154. Liu XC,Zhou WY,He Y,et al.Investigation and analysis of clinicalchemistry internal quality control coefficient of variation of the mutual recognition of test items in Guangxi tertiary hospital laboratories[J].J Mod Lab Med,2013,28(5):147-150,154.
[5] 白 玉,王治国,王 薇,等.全国常规化学检验项目室内质控变异系数的分析[J].检验医学,2011,26 (3):207-209. Bai Y,Wang ZG,Wang W,et al.Analysis of coefficient of variationof internal quality control of routine chemistry items[J].Lab Med,2011,26(3):207-209.
[6] Skiek M.Acceptability limits based on biology goals in haematology EQAS[J].Accred Qual Assur,2005,10(3):112-115.
[7] Klee GG.Establishment of outcome-related analytic performance goals[J].Clin Chem,2010,56 (5):714-722.
[8] Fraser CG.General strategies to set quality specifications for reliability performance characteristics[J].Scand J Clin Lab Invest,1999,59(7):487-490.
[9] 王治国.临床检验质量控制技术[M].3版.北京:人民卫生出版社,2014:124. Wang ZG.Quality control technology in clinical laborato-ry[M].3th Ed.Beijing:People's Medical Publishing House,2014:124.

相似文献/References:

[1]张培育,邓演超,李全双.自制C肽质控品及其性能评价[J].现代检验医学杂志,2016,31(03):156.[doi:10.3969/j.issn.1671-7414.2016.03.044]
　ZHANG Pei-yu,DENG Yan-chao,LI Quan-shuang.Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums[J].Journal of Modern Laboratory Medicine,2016,31(06):156.[doi:10.3969/j.issn.1671-7414.2016.03.044]
[2]张 路,王 薇,何法霖,等.国内临床实验室同型半胱氨酸室内质量控制变异系数调查与分析[J].现代检验医学杂志,2015,30(04):132.[doi:10.3969/j.issn.1671-7414.2015.04.040]
　ZHANG Lu,WANG Wei,HE Fa-lin,et al.Investigation and Analysis of the Coefficient of Variation of Internal Quality Control of Homocysteine[J].Journal of Modern Laboratory Medicine,2015,30(06):132.[doi:10.3969/j.issn.1671-7414.2015.04.040]
[3]刘佳丽,王 薇,何法霖,等.全国566家临床实验室血清降钙素原室内质量控制不精密度调查与分析[J].现代检验医学杂志,2018,33(02):139.[doi:10.3969/j.issn.1671-7414.2018.02.001]
　LIU Jia-li,WANG Wei,HE Fa-lin,et al.Investigation and Analysis of the Coefficient of Variation of Internal Quality Control of the Serum Procalcitonin in 566 Laboratories in China[J].Journal of Modern Laboratory Medicine,2018,33(06):139.[doi:10.3969/j.issn.1671-7414.2018.02.001]
[4]张志新,王 薇,何法霖,等.2014～2017年我国临床实验室HbA2和HbF检测室内质控变异系数分析[J].现代检验医学杂志,2018,33(02):143.[doi:10.3969/j.issn.1671-7414.2018.02.001]
　ZHANG Zhi-xin,WANG Wei,HE Fa-lin,et al.Analysis of the Coefficient of Variation for the Internal Quality Control of Hemoglobin A2 and Hemoglobin F from 2014 to 2017[J].Journal of Modern Laboratory Medicine,2018,33(06):143.[doi:10.3969/j.issn.1671-7414.2018.02.001]
[5]王 晟a,段小勇b,刘兴态a,等.临床POCT检测项目质量管理体系的建立与实践[J].现代检验医学杂志,2019,34(02):147.[doi:10.3969/j.issn.1671-7414.2019.02.038]
　WANG Shenga,DUAN Xiao-yongb,LIU Xing-taia,et al.Establishment and Practice of Quality Management Systemfor Clinical POCT Testing Project[J].Journal of Modern Laboratory Medicine,2019,34(06):147.[doi:10.3969/j.issn.1671-7414.2019.02.038]
[6]毛 瑞,曹三成,王 娟,等.临床实验室干式生化检测项目测量不确定度的评估与分析[J].现代检验医学杂志,2019,34(05):153.[doi:10.3969/j.issn.1671-7414.2019.05.039]
　MAO Rui,CAO San-cheng,WANG Juan,et al.Evaluation and Analysis of Uncertainty in Measurement of Dry Biochemical Testing Items in Clinical Laboratories[J].Journal of Modern Laboratory Medicine,2019,34(06):153.[doi:10.3969/j.issn.1671-7414.2019.05.039]

备注/Memo

备注/Memo:
基金项目:北京市自然科学基金资助项目 (7143182)。 作者简介:费 阳(1991-),女,在读研究生,研究方向:实验室质量管理,E-mail:277475101@qq.com。 通讯作者:王治国,硕士,研究员,主要从事临床检验技师质量控制方法研究和室间质量评价工作,E- mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2016-12-20