[1]刘佳丽,王 薇,何法霖,等.脑脊液生化检测室内质量控制不精密度分析及Westgard西格玛规则的应用[J].现代检验医学杂志,2018,33(03):154-157.[doi:10.3969/j.issn.1671-7414.2018.03.040]
　LIU Jia-li,WANG Wei,HE Fa-lin,et al.Analysis on the Coefficient of Variation of Internal Quality Control in Cerebrospinal Fluid and Application of Westgard Sigma Rule[J].Journal of Modern Laboratory Medicine,2018,33(03):154-157.[doi:10.3969/j.issn.1671-7414.2018.03.040]
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脑脊液生化检测室内质量控制不精密度分析及Westgard西格玛规则的应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年03期
页码:
154-157
栏目:
质量控制·实验室管理
出版日期:
2018-07-17

文章信息/Info

Title:
Analysis on the Coefficient of Variation of Internal Quality Control in Cerebrospinal Fluid and Application of Westgard Sigma Rule
文章编号:
1671-7414(2018)03-154-04
作者:
刘佳丽; 王 薇; 何法霖; 钟 堃; 袁 帅; 张志新; 杜雨轩; 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):
LIU Jia-li; WANG Wei; HE Fa-lin; ZHONG Kun; YUAN Shuai; ZHANG Zhi-xin; DU Yu-xuan;  WANG Zhi-guo
Beijing Hospital,National Center of Gerontology,National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine,Beijing 100730,China
关键词:
脑脊液生化;  室内质量控制;  变异系数;  Westgard西格玛规则;  质控规则
分类号:
R446.14
DOI:
10.3969/j.issn.1671-7414.2018.03.040
文献标志码:
A
摘要:
目的 分析脑脊液生化检测项目室内质量控制不精密度及Westgard西格玛规则在葡萄糖项目室内质量控制(IQC)中的应用。方法 收集2014～2017年参加卫生部临床检验中心室间质量评价(EQA)单位回报的IQC数据,依据1/3TEa(室间质量评价限),1 /4TEa计算得到满足两种标准的实验室比例。根据IQC所使用的检测系统进行分组统计,并按两个评价标准计算各组的通过率。随机选择2017年10家同时上报葡萄糖项目EQA和IQC的实验室,以EQA中的百分差值作为偏倚(bias)估计值,以IQC的累积变异系数作为不精密度估计值,以EQA计划中的允许总误差TEa作为质量规范,依据公式σ=[(TEa-|bias|)/CV]计算σ值。结果 2014～2017年间清蛋白、总蛋白、氯化物3个项目达到两种标准的不精密度性能规范的实验室比例较低。葡萄糖、乳酸脱氢酶、IgA,IgG,IgM和乳酸6个项目通过率相对较高,且各项目的通过率略有上升趋势。使用不同检测系统的通过率比例参差不齐,并无规律。使用Westgard西格玛规则为葡萄糖项目选择合适的质控规则。3号实验室σ值>6,6σ质量应选择13s规则; 2,5,7号σ值分别为4.84,4.47和4.72,4σ质量水平应选择13s/22s/R4s/41s规则; 其余实验室σ值均<4,选用13s/22s/R4s/41s/8x规则。结论 各项目的IQC不精密度水平存在很大差距,各实验室应建立严格的IQC程序,积极参与IQC数据实验室间比对,进一步提高脑脊液生化检测的水平,并通过Westgard西格玛规则为实验室检测项目选择正确的质控规则。
Abstract:
Abstract:Objective To analyze the coefficient of variation of internal quality control(IQC)in cerebrospinal fluid(CSF)and applicationof Westgard sigma rule in IQC of glucose project.Methods The results of IQC reported by the laboratories which participated in externalquality assessment(EQA)of National Center for Clinical Laboratories(NCCL)from2014 to 2017 were collected,and then the coefficient of variation was comparedwith 1/3TEa and 1/4TEa.The instruments which had been used in laboratory internal quality control system of EQA based on CSF project were grouped and counted,and the acceptable rates of each group was calculated according to two evaluation standards.Randomlychose 10 laboratories from all participants that attendedboth glucose IQC and EQA schemes in 2017.The percentage difference in EQA schemes was viewed as the estimation value of bias,while the accumulated coefficient of variation in the IQC schemes was the estimation value of imprecision.Usedthe total allowable errors based upon EQA schemes was as the quality specification,calculating sigma value by the equation σ=[(TEa-|bias|)/CV].Results From 2014 to 2017,the acceptable rates of CVs met the two evaluation standards of albumin,total protein,chloride were relativelylow,and the acceptable rates of six projects of glucose,lactate dehydrogenase,IgA,IgG,IgM and lactic acid were relatively high.The acceptable rate of each project increased slightly.The ratio of passing rate of different instrumentsystem was different and irregular.Used the Westgard sigma rule to choose appropriate quality control rules for glucose projects.No.2 laboratory with sigmavalue more than 6 had to select 13s rule.No.2,5 and 7 whose sigma value were 4.84,4.47 and 4.72,should make a choice of 13s/22s/R4s/41s multirules.In addition,the 13s/22s/R4s/41s/8x multirules were selected for other laboratories whose sigma value were less than 4.Conclusion There was a big gap in the coefficient of variation between the IQC of each project.Laboratories shouldestablish strict IQC procedure,participate in inter-laboratory comparison andimprove the detection quality level much further.Clinical laboratories can take advantage of Westgard sigma rules to correctly choose the quality control rules.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:刘佳丽(1990-),女,本科,检验技师,研究方向:临床实验室管理,E-mail:1253480821@qq.com。 通讯作者:王治国,硕士,研究员,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2018-04-16