[1]张诗诗,王 薇,赵海建,等.Westgard西格玛规则在糖化血红蛋白检验项目室内质量控制中的选择应用[J].现代检验医学杂志,2016,31(02):157-160.[doi:10.3969/j.issn.1671-7414.2016.02.046]
　ZHANG Shi-shi,WANG Wei,ZHAO Hai-jian,et al.Application of Westgard Sigma Rules in Selecting Internal Quality Control Rules for Hemoglobin A1C Tests[J].Journal of Modern Laboratory Medicine,2016,31(02):157-160.[doi:10.3969/j.issn.1671-7414.2016.02.046]
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Westgard西格玛规则在糖化血红蛋白检验项目室内质量控制中的选择应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年02期
页码:
157-160
栏目:
质量控制·实验室管理
出版日期:
2016-06-01

文章信息/Info

Title:
Application of Westgard Sigma Rules in Selecting Internal Quality Control Rules for Hemoglobin A1C Tests
作者:
张诗诗1; 2; 王 薇2; 赵海建2; 王治国1; 2
1.北京协和医学院研究生院,北京 100730; 2.北京医院 卫生部临床检验中心,北京 100730
Author(s):
ZHANG Shi-shi1; 2; WANG Wei2; ZHAO Hai-jian2; WANG Zhi-guo1; 2
1.Graduate School of Reking Union Medical College,Beijing 100730,China; 2.National Center for Clinical Laboratories,Beijing Hospital,Beijing 100730,China
关键词:
Westgard西格玛规则;  糖化血红蛋白;  室内质量控制;  质控规则
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.02.046
文献标志码:
A
摘要:
目的 运用Westgard西格玛规则帮助临床实验室选择适合糖化血红蛋白(HbA1C)检验项目的室内质量控制(质控)规则。方法 在参加2015年卫生部临床检验中心HbA1C室间质量评价(EQA)和室内质控(IQC)计划的所有实验室中按地区(华北、华中、华东等)随机选取10家,把每家实验室在EQA计划中的百分差值当作其偏倚(bias)的估计值,在IQC计划中的累积变异系数当作其不精密度(CV)的估计值。以生物学变异导出的适当要求、美国病理家学会(CAP)、中国EQA计划中的允许总误差(TEa)作为质量规范,利用公式σ=[(TEa-|bias|)/CV]计算σ值,结合Westgard西格玛规则为各实验室HbA1C检验项目选择正确的质控规则。结果 使用基于生物学变异的TEa,各实验室σ值均<2,应选13s/22s/R4s/41s/规则。使用源自CAP的TEa,2号实验室σ值为5.04,应选13s/22s/R4s规则; 其余实验室σ值均<4,应选13s/22s/R4s/41s/规则。使用我国EQA计划可接受限作为TEa,2号实验室σ值>6,应选13s规则; 1号实验室σ值为5.45,应选13s/22s/R4s规则; 6,10号实验室σ值分别为4.76和4.18,应选13s/22s/R4s/41s规则; 其余实验室σ值均<4,应选13s/22s/R4s/41s/规则。结论 临床实验室可以运用简便快捷的Westgard西格玛规则为检验项目选择正确的质控规则。
Abstract:
Objective To help clinical laboratories to select internal quality control rules which was adapt to HemoglobinA1C(HbA1C)testsby the use of Westgard Sigma Rules.Methods Randomly chose 10 clinical laboratories in accordance with region(Northern China,Central China,Eastern China,et al)from all participants that attended both HbA1C external quality assessment(EQA)and internal quality control(IQC)schemes in 2015.The percentage difference in the external quality assessment scheme was viewed as the estimation value of bias,while the accumulated coefficient of variation in the internal quality control scheme was used as the estimation value of imprecision.Using the total allowable errors based upon desirable requirements from biological variation.College of American Pathologists(CAP)and EQA scheme of China as the quality specification,calculating sigma value by the equation σ=[(TEa-|bias|)/CV] and then combining Westgard Sigma Rules to choose proper quality control rules for HbA1C tests in every laboratory.Results Using the total allowable error based upon biological variation as quality specification,13s/22s/R4s/41s/multi-rules were selected for all laboratories whose sigma values were less than 2.If the total allowable error derived from CAP was used,No.2 laboratory(the number represents the corresponding laboratories in the following)should choose13s/22s/R4smultirules due to its sigma value 5.04and other laboratories whose sigma values were less than 4 should choose 13s/22s/R4s/41s/multi-rules.When the total allowable error from acceptable limits of Chinese EQA sheme was employed,No.2 laboratory with sigma value more than 6 had to select 13s rule,No.1 laboratory with sigma value 5.45 should make achoice of 13s/22s/R4s multirules,and 13s/22s/R4s/41s multirules were suitable option for No.6 and No.10 laboratory whose sigma values were 4.76 and 4.18,respectively.In addition,13s/22s/R4s/41s/multi-rules were selected for other laboratories whose sigma values were less than 4.Conclusion Due to theconvenience and rapidness,clinical laboratories can take advantage of WestgardSigma Rules to correctly choose quality control rules.

参考文献/References:

[1] 中华人民共和国国家卫生和计划生育委员会.WS/T 461-2015 糖化血红蛋白检测[S].北京:中国标准出版社,2015. National Health and Family Planning Commission of the People's Republic of China.WS/T 461-2015,Measurement of Hemoglobin A1C[S].Beijing:Standards Press of China,2015.
[2] 费 阳,王 薇,王治国.临床检验室内质量控制规则设计新工具-Westgard西格玛规则[J].现代检验医学杂志,2015,30(1):149-152. Fei Y,Wang W,Wang ZG.A new internal quality control rules designtool in clinical laboratory-Westgard sigma rules[J].Journal of Modern Laboratory Medicine,2015,30(1):149-152.
[3] Desirable Biological Variation Database specifications[EB/OL](2014).https://www.westgard.com/quality-requirements.htm.
[4] 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.
[5] College of Americun Pathologists(CAP)GH-5a 2015 summary[EB/OL](2015).https://www.ngsp.org/CAPdata.asp.
[6] Westgard JO,Groth T.Power functions for statistical control rules[J].Clin Chem,1979,25(6):863-869.
[7] Westgard JO.Charts of Operational process specifications(OPSpecs Charts)for assessing the precision,accuracy,and quality control needed to satisfy proficiency testing criteria[J].Clin Chem,1992,38(7):1226-1233.
[8] 王治国.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 interval in clinical laboratory[M].Beijing:People's Medical Publishing House,2012.
[9] Friedecky B,Krathochvila J,Budina M.Why do different EQA shemes have apparently different limits of acceptability[J].Clin Chem Lab Med,2011,49(4):743-745.

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备注/Memo

备注/Memo:
基金项目:北京市自然科学基金资助项目(7143182),北京医院课题资助(BJ-2015-025)。 作者简介:张诗诗(1991-),女,在读硕士研究生,研究方向:实验室质量管理。 通讯作者:王治国,研究员,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2016-02-20