[1]汪蓓蕾,侯秉璋,郭 刚.Westgard西格玛规则和生物学变异确定的质量规范在新生儿筛查项目中的应用[J].医学信息,2022,35(02):105-109.[doi:10.3969/j.issn.1006-1959.2022.02.025]
　WANG Bei-lei,HOU Bing-zhang,GUO Gang.Application of Westgard Sigma Rules and Quality Criteria for Biological Variantsin Neonatal Screening Projects[J].Medical Information,2022,35(02):105-109.[doi:10.3969/j.issn.1006-1959.2022.02.025]
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Westgard西格玛规则和生物学变异确定的质量规范在新生儿筛查项目中的应用()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
35卷
期数:
2022年02期
页码:
105-109
栏目:
论著
出版日期:
2022-01-15

文章信息/Info

Title:
Application of Westgard Sigma Rules and Quality Criteria for Biological Variantsin Neonatal Screening Projects
文章编号:
1006-1959（2022）02-0105-05
作者:
汪蓓蕾; 侯秉璋; 郭 刚
天津医科大学朱宪彝纪念医院天津市内分泌研究所，天津 300134
Author(s):
WANG Bei-lei; HOU Bing-zhang; GUO Gang
Tianjin Medical University Chu Hsien-I Memorial Hospital,Tianjin Institute of Endocrinology,Tianjin 300134,China
关键词:
新生儿筛查; 生物学变异; Westgard西格玛规则; 质量控制
Keywords:
Neonatal screening; Biological variation; Westgard sigma rules; Quality control
分类号:
R446.1
DOI:
10.3969/j.issn.1006-1959.2022.02.025
文献标志码:
A
摘要:
目的 利用Westgard西格玛规则和基于生物学变异的质量规范，评价新生儿筛查项目分析性能，指导选择室内质量控制（IQC）规则及质量改进。方法 于2019年10月-2020年10月对国家卫生健康委临床检验中心（NCCL）提供的4批次新筛项目室间质量评价（EQA）样本进行苯丙氨酸（Phe）、促甲状腺激素（TSH）检测并取得EQA回报结果，同时选取同期IQC数据，分别获得两项目的实验室偏倚（Bias）和不精密度（CV），以生物学变异导出的允许总误差（TEa）为要求，计算项目西格玛（σ）值，绘制标准化σ性能验证图选择质控规则；计算质量目标指数（QGI），查找导致项目性能不佳的主要原因。结果 Phe采用生物学变异导出最低要求，低浓度性能一般（σ＜4），使用13S/22S/R4S/41S/8x规则；高浓度性能优秀（σ＞5）。TSH以适当性能要求，低、高浓度性能均一般（σ＜4），选择13S/22S/R4S/41S/8x规则。两项目QGI指数均＜0.8，优先改进精密度。结论 基于生物学变异质量规范是实验室质量管理的更高层次，Westgard西格玛规则能够客观、有效地评价新筛项目分析性能，有助于筛查实验室质量水平不断提高。
Abstract:
Objective To evaluate the analytical performance of inherited metabolic diseases screening tests with Westgard sigma rules and quality specification derived from biological variation ,in order to select suitable internal quality control rules(IQC) and to promote the qualitv improvement.Methods From October 2019 to October 2020, phenylalanine (Phe) and thyroid stimulating hormone (TSH) were detected in four batches of EQA samples of new screening projects provided by National Health and Health Commission Clinical Laboratory Center (NCCL), and EQA reward results were obtained. Meanwhile, IQC data of the same period were selected to obtain laboratory bias (Bias) and inaccuracy (CV) of the two projects, respectively. The allowable total error (TEa) derived from biological variation was used as the requirement to calculate the Sigma (σ) value of the project, and the standardized σ performance verification diagram was drawn to select the quality control rules. Calculate the Quality Objective Index (QGI) to find out the main reasons for poor project performance.Results The minimum requirement of Phe was derived by biological variation, and the low concentration performance was general (σ<4), 13S/22S/R4S/41S/8 x multi-rules were selected; the high concentration performance was excellent(σ>5).TSH with appropriate performance requirements, low and high concentration performance were general (σ<4),13S/22S/R4S/41S/8 xmulti-rules were selected. The calculated QGI of the analytes were all less than 0.8, suggesting that the detection precision needed to be improved first.Conclusion The quality specifications derived from biological variation is a higher standard of quality requirements, and the use of Westgard sigma rules can effectively and exactly evaluate the performance of inherited metabolic diseases screening tests and is conducive to continuous quality improvement of neonatal screening laboratory.

参考文献/References:

[1]童凡,赵正言.新生儿疾病筛查结果解读[J].中华儿科杂志,2019,57(6):494-496.[2]傅启华,郑昭璟.新生儿遗传代谢性疾病的实验室筛查与诊断[J].中华检验医学杂志,2014,37(4):248-251.[3]Westgard QC website.Desirable Biological Variation Database Specifications[EB/OL].https://www.westgard.com/biodatabase1.htm,2020-12-12/2021-05-31.[4]European Federation of Clinical Chemistry and Laboratory Medicine(EFLM) website.The EFLM Biological Variation Database[EB/OL].https://biologicalvariation.eu/,2020-12-12/2021-05-31.[5]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.[6]Westgard QC website.QC Selection Grid [EB/OL].https://www.westgard.com/mqcsg2.htm,2020-12-12/2021-05-31.[7]吴海婴,左林,韦入翠,等.标准化西格玛性能验证图在临床生化质量管理中的应用[J].标记免疫分析与临床,2020,27(7):1241-1246.[8]李润清,宫丽君,王腾蛟,等.西格玛方法在临床生化检验检验质量管理中的应用[J].中华检验医学杂志,2017,40(9):727-732.[9]Sandberg S,Fraser CG,Horvath AR,et al.Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine[J].Clin Chem Lab Med,2015,53(6):833-835.[10]冯仁丰.临床实验室分析质量目标的共识(上)[J].检验医学,2016,31(1):1-8.[11]程威,孙亦骏,梁晓威,等.江苏省苯丙氨酸室内质量控制数据实验室间比对结果与分析[J].临床检验杂志,2016,34(6):470-473.[12]Carobene A,Strollo M,Jonker N,et al.Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine [J].Clin Chem Lab Med,2016,54(10):1599-1608. [13]Tze PL,Sunil KS,Michael P.Paediatric reference interval and biological variation trends of thyrotropin (TSH) and free thyroxine (T4) in an Asian population[J].J Clin Pathol,2015,68(8):642-647.[14]王琼,齐志业,赵小龙,等.新生儿遗传代谢病筛查室间质量评价5年回顾[J].中国妇幼健康研究,2018,29(10):1292-1295.[15]黄丽辉.解读2010年版新生儿听力筛查技术规范[J].听力学及言语疾病杂志,2011,19(6):495-496. [16]王琼,齐志业,赵小龙,等.2016年至2019年先天性甲状腺功能减低症筛查质量分析[J].中国妇幼健康研究,2020,31(10):1349-1354.[17]宋真真,李臣宾,周文宾,等.血细胞分析全国质评参加实验室的室内质量控制数据分析[J].中华医学杂志,2018,98(24):1931-1936.[18]洪冬洋,王彦云,孙云,等.患者数据移动均值法在新生儿遗传代谢病筛查项目室内质控的应用[J].中华临床实验室管理电子杂志,2019,7(3):169-172. [19]张慧,田永芳,王昌敏,等.新疆地区参加全国新生儿疾病筛查实验室室间质评7年回顾[J].国际检验医学杂志,2017,38(13):1732-1734,1737.

更新日期/Last Update: 1900-01-01