[1]钟堃,王薇,何法霖,等.2014年全国452家实验室全血铜、锌、钙、镁、铁检验项目实验室内不精密度分析[J].现代检验医学杂志,2015,30(06):149-153.[doi:10.3969/j.issn.1671-7414.2015.06.046]
　ZHONG Kun,WANG Wei,HE Fa-lin,et al.Analysis of the Imprecision of Internal Quality Control of 452 Laboratories Testing Copper，Zinc，Calcium，Magnesium and Iron in Whole Blood of Children in China[J].Journal of Modern Laboratory Medicine,2015,30(06):149-153.[doi:10.3969/j.issn.1671-7414.2015.06.046]
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2014年全国452家实验室全血铜、锌、钙、镁、铁检验项目实验室内不精密度分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年06期
页码:
149-153
栏目:
质量控制·实验室管理
出版日期:
2015-12-30

文章信息/Info

Title:
Analysis of the Imprecision of Internal Quality Control of 452 Laboratories Testing Copper，Zinc，Calcium，Magnesium and Iron in Whole Blood of Children in China
作者:
钟堃; 王薇; 何法霖; 王治国
北京医院卫生部临床检验中心，北京100730
Author(s):
ZHONG Kun; WANG Wei; HE Fa-lin; WANG Zhi-guo
Beijing Hospital，National Center for Clinical Laboratories，Beijing 100730，China
关键词:
全血五元素; 临床检验; 室内质量控制; 生物学变异
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.06.046
文献标志码:
A
摘要:
目的调查全血五元素(铜、锌、钙、镁、铁)室内质量控制的精密度现状，并与目前所确定的生物学变异(此处作为室内质量控制精密度的评价标准)进行比较，提出改进措施。方法采用基于Web方式的室间质量评价(external quality assessment，EQA)软件系统，收集2014年参加全国全血五元素检验室间质量评价计划的实验室的室内质量控制数据，为2014年2月份的452家实验室，包括当月的和累积的室内质量控制变异系数，所使用的方法、仪器等信息，其他室内质量控制相关信息等。使用Microsoft Excel 2007和SPSS 13.0对数据进行分析。根据生物学变异导出最佳、适当和最低允许不精密度的评价标准，计算这5个项目的室内质量控制变异系数的通过率。全血五元素铜、锌、钙、镁、铁的生物学变异，适当、最低和最佳标准分别为铜2.50%，3.68%和1.23%；锌4.70%，6.98%和2.33%；钙1.00%，1.43%和0.48%；镁1.80%，2.70%和0.90%；铁13.30%，19.88%和6.63%。结果377~382家实验室有效的上报了批号1的室内质控数据，96家实验室上报了批号2。达到适当质量规范的变异系数比例范围：批号1(2014年2月)，1.85%(钙)~95.5%(铁)；批号2(2014年2月)，3.13%(钙)~96.88%(铁)；批号1(累积)，2.82%(钙)~96.06%(铁)；批号2(累积)，1.10%(钙)~98.90%(铁)。各批号内不同质量规范的各检验项目间不精密度的通过率差异均有统计学显著性意义(P＜0.01)。目前有A，B，C三个检测系统，除铜当月不精密度适当和最低标准，锌当月和累积不精密度的适当和最低标准，钙累积不精密度最低标准和铁累积不精密度最佳标准外，其余项目和标准各检测系统间均差异无统计学显著性意义(P＞0.05)。结论通过对当月和累积的室内质控数据的变异系数的监测，并将室内质量控制数据计算的变异系数与相关要求进行比较，可以评价该检测系统的不精密度水平是否满足规定的质量要求。对于全血五元素项目来说，除了铁外，目前使用基于生物学变异的质量规范来评价不精密度水平还是过于严格了。
Abstract:
ObjectiveTo investigate the coefficient of variations (CV) of internal quality control (IQC) of five elements (copper，zinc，calcium，magnesium，and iron) of whole blood in children testing，and compare with the quality specification derived from biological variations．MethodsData had been collected by web-based submission system，the laboratories which enrolled in 2014 five elements of whole blood in children external quality assessment (EQA) program had attended．The data was included：the CV of February of 2014 and long-term cumulative data，method and instrument，etc．Microsoft Excel 2007 and SPSS 13.0 had been used to analyze the data．The optimum，desirable and minimum performance of quality specification of allowable imprecision had been derived from biological variations，1.23%，2.50% and 3.68% for copper，2.33%，4.70% and 6.98% for zinc，0.48%，1.00% and 1.43% for calcium，0.90%，1.80% and 2.70% for magnesium，6.63%，13.30% and 19.88% for iron，respectively．Results377~382 laboratories reported effective results，96 of them reported CV of two lots of IQC material．The range of acceptable rate of CV meeting desirable quality specification was：lot 1 (February)，1.85% (calcium) to 95.5% (iron)；lot 2 (February)，3.13% (calcium) to 96.88% (iron)；lot 1 (cumulative)，2.82% (calcium) to 96.06% (iron)；lot 2 (cumulative)，1.10% (calcium) to 98.90% (iron)．There was significant difference between analytes in the acceptable rate of CV of each lot of IQC material for every quality specification(P＜0.01)．The mainstream of measurement systems of five elements of whole blood in children testing in China were A，B and C．There was no significant difference of the acceptable rate of CV between different measurement systems for all quality specification (P＞0.05)，except the February CV of copper and zinc，cumulative CV of zinc for desirable and minimum quality specification，cumulative CV of calcium for minimum quality specification，and cumulative CV of iron for optimum quality specification．ConclusionIt is an effective method for clinical laboratories to improve test quality by monitoring the current and cumulative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification．For the five elements of whole blood，the quality specification derived from biological variation was too strict to be used in the quality assessment for clinical laboratories in China．

参考文献/References:

［1］王薇，钟堃，李少男，等．全血五元素检测的实验室间质量调查结果分析［J］．中国预防医学杂志，2010，11(8)：839-841． Wang W，Zhong K，Li SN，et al．The analysis of results of investigation of performance of inter-laboratory providing the test of five elements in whole blood［J］．Chinese Prevention Medicine，2010，11(8)：839-841．
[2]Tapiero H，Townsend DM，Tew KD．Trace elements in human physiology and pathology Copper［J］．Biomedicine & Pharmacotherapy，2003，57(9)：386-398．
[3]Seyrek A，Kocyigit A，Erel O．Essential trace elements selenium，zinc，copper，and iron concentrations and their related acute-phase proteins in patients with vivax malaria［J］．Biological Trace Element Research，2005，106(2)：107-115．
[4]Kocyigit A，Armutcu F，Gurel A，et al．Alterations in plasma essential trace elements selenium，manganese，zinc，copper and iron concentrations and the possible role of these elements on oxidative status in patients with childhood asthma［J］．Biological Trace Element Research，2004，97(1)：31-41．
[5]赵海建，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 coefficient of variation of interval quality control of lipid testing［J］．Chinese Journal of Laboratory Medicine，2012，35(12)：1172-1175．
[6]Fraser CG．General strategies to set quality specifications for reliability performance characteristics［J］．Scand J Clin Lab Invest，1999，59(7)：487-490．
[7]Skitek M．Acceptability limits based on biology goals in haematology EQAS［J］．Accred Qual Assur，2005，10(3)：112-115．
[8]Klee GG．Establishment of outcome-related analytic performance goals［J］．Chin Chem，2010，56(5)：714-722．
[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． Wang ZG．The techniques of clinical tests quality control［M］．3th Ed．Beijing：People’s Health Press，2014．
[10]陈文样．申子瑜，杨振华．临床检验分析质量指标的设定［J］．中华检验医学杂志，2006，29(4)：298-300． Chen WX，Shen ZY，Yang ZH．Analytical quality spe-cifications in laboratory medicine［J］．Chinese Journal of Laboratory Medicine，2006，29(4)：298-300．
[11]何法霖，白玉，王薇，等．由生物学变异确定的质量规范在常规化学室间质评和室内质控中的应用［J］．中华检验医学杂志，2012，35(6)：531-537． He FL，Bai Y，Wang W，et al．The application of qu-ality specifications derived from biological variation in routine chemistry external quality assessment and internal quality control［J］．Chinese Journal of Laboratory Medicine，2012，35(6)：531-537．
[12]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 for imprecision and variation in internal quality control of nationwide routine chemistry［J］．Laboratory Medicine，2011，26(3)：207-209．
[13]Ricos C，Alvarez V，Cava F，et al．Current databases on biological variation：pros，cons and progress［J］．Scand J Clin Lab Invest，1999，59(7)：491-500．
[14]王治国，王薇，李小鹏，等．临床检验生物学变异与参考区间［M］．北京：人民卫生出版社，2012． Wang ZG．Biological variation and reference intervals of clinical laboratories［M］．Beijing：People’s Medical Publishing House，2012．
[15]Kinns H，Pitkin S，Housley D，et al．Internal quality control：best practice［J］．J Clin Pathol，2013，66(12)：1027-1032．
[16]肖亚玲，王薇，王治国．ISO 15189：2012与室内质量控制［J］．临床检验杂志，2014，32(2)：124-125． Xiao YL，Wang W，Wang ZG．ISO 15189：2012 and internal quality control［J］．Chinese Journal of Clinical Laboratory Science，2014，32(2)：124-125．
[17]王治国，王薇，李小鹏，等．应用操作过程规范图设计临床检验室内质控方法［J］．中国卫生统计，2003，20(5)：292-295． Wang ZG，Wang W，Li XP，et al．Apply Operational Process Specifications chart to design the method of clinical tests internal quality control［J］．China Health Statistics，2003，20(5)：292-295．
[18]王治国．临床检验方法确认与性能验证［M］．北京：人民卫生出版社，2009． Wang ZG．The methods accreditation and performance verification of clinical laboratory［M］．Beijing：People’s Medical Publishing House，2009．

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：钟堃(1984-)，男，满族，助理研究员，主要从事临床实验室管理工作。 作者通讯：王治国，E-mail：zgwang@ncclorg.cn。
更新日期/Last Update: 1900-01-01