[1]王 辉,徐克和,唐书强,等.临床化学实验室质量控制计算实际西格玛值的新方法[J].现代检验医学杂志,2019,34(02):132-136.[doi:10.3969/j.issn.1671-7414.2019.02.034]
　WANG Hui,XU Ke-he,TANG Shu-qiang,et al.New Method for Calculating the Actual Sigma Metricsin Clinical Chemistry Laboratory Quality Control[J].Journal of Modern Laboratory Medicine,2019,34(02):132-136.[doi:10.3969/j.issn.1671-7414.2019.02.034]
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临床化学实验室质量控制计算实际西格玛值的新方法()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年02期
页码:
132-136
栏目:
质量控制·实验室管理
出版日期:
2019-05-11

文章信息/Info

Title:
New Method for Calculating the Actual Sigma Metricsin Clinical Chemistry Laboratory Quality Control
文章编号:
1671-7414(2019)02-132-05
作者:
王 辉; 徐克和; 唐书强; 黄亨建
(四川大学华西医院实验医学科,成都 610041)
Author(s):
WANG Hui; XU Ke-he; TANG Shu-qiang; HUANG Heng-jian
(Department of Laboratory Medicine,the West China Hospital of Sichuan University,Chengdu 610041,China)
关键词:
六西格玛;  质量控制
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2019.02.034
文献标志码:
A
摘要:
目的 计算实际西格玛(sigma,σ)值,正确评估实验室检测项目分析性能。方法 方法①结合室内质量控制(internal quality control,IQC),与室间质量评价(external quality assessment,EQA),计算westgard两种σ计算公式σ1=(TEa-bias)/(s)和σ2=(TEa%-bias%)/(CV%)下的σ1与σ2值。以IQC累积均值χ1与EQA靶值μ2的比值(χ1/μ2)为横轴,σ1,σ2为纵轴绘制散点图,比较σ1,σ2的关系; 方法②以伯乐公司全球质控材料,批号为45751和45753,仪器为罗氏Cobas 8000全自动生化分析仪,累积到2018年1月份的均值作为靶值μ1,结合IQC数据计算Westgard两种公式下检测项目的σ1,σ2值。结果 方法①计算的σ1与σ2值并不相同,甚至相差很大,而且对钠(Na)、氯(Cl)、钙(Ca)三个TEa要求高的检测项目,σ值计算结果为负值。比较σ1,σ2的关系,当χ1/μ2<1时,σ1>σ2; 当χ1/μ2>1时,σ1<σ2。方法②中χ1 /μ1值接近于1,σ1,σ2大小非常接近。结论 结合IQC与EQA计算σ时,应选取与质控材料同一浓度水平的测定值,这才能真实反映实验室检测项目分析性能。
Abstract:
Objective To calculate the actual sigma metrics(σ)and correctly evaluate analytical performance of tests.MethodsMethod① combined internal quality assessment(IQC)with external quality assessment(EQA),σ1 and σ2 of two σ calculation formulas of westgard were calculated:σ1=(TEa-bias)/(s)and σ2=(TEa%-bias%)/(CV%).The ratio of cumulative mean χ1 of IQC to target value μ2 of EQA(χ1/μ2)were plotted on the horizontal axis,and σ1 and σ2 were plotted on the vertical axis.The relationship betweenσ1 and σ2 were compared.Method② was based on the quality control materials from Bio-Rad laboratory with batch numbers of 45 751 and 45 753.The instrument was the Roche Cobas 8 000 automatic biochemical analyzer.The average valueaccumulated in January 2018 was taken as the target value μ1.The IQC data was used to calculate σ1 and σ2 of tests using Westgard formula.Results σ1 and σ2 calculated by method ① were different,andthe σ value were negative for tests with high TEa requirements such as Na,Cl and Ca.In the relationship of σ1 and σ2,when χ1/μ2<1,σ1>σ2; when χ1/μ2>1,σ1<σ2.In the method ②,the value of χ1/μ1 was close to 1,and the values of σ1 and σ2 were very close.Conclusion When calculating σ by combining IQC and EQA.The measured value at the same concentration level as the quality control material should be selected,which can truly reflect analytical performance of tests.

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备注/Memo

备注/Memo:
基金项目:四川省科技厅(2017SZ0063和2014SZ0170)。 作者简介:王 辉(1982-),女,大学本科,研究方向:实验室管理,E-mail: 244183570@qq.com。 通讯作者:黄亨建(1964-),男,副主任技师,E-mail:huanghenjian@sina.com。 收稿日期:2018-12-12 修回日期:2019-02-15
更新日期/Last Update: 2019-04-30