[1]周玉侠,牛婷婷,吴玉苏,等.山东省18家新生儿疾病筛查中心实验室TSH和17α-OHP项目室内质控数据室间比对分析[J].现代检验医学杂志,2019,34(02):140-143.[doi:10.3969/j.issn.1671-7414.2019.02.036]
　ZHOU Yu-xia,NIU Ting-ting,WU Yu-su,et al.Inter-Laboratory Comparison of Internal Quality Control Dataof Neonatal Disease Screening Indicators TSH and 17 alpha- OHPin 18 Newboring Screening Laboratory in Shandong Province[J].Journal of Modern Laboratory Medicine,2019,34(02):140-143.[doi:10.3969/j.issn.1671-7414.2019.02.036]
点击复制

山东省18家新生儿疾病筛查中心实验室TSH和17α-OHP项目室内质控数据室间比对分析()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年02期
页码:
140-143
栏目:
质量控制·实验室管理
出版日期:
2019-05-11

文章信息/Info

Title:
Inter-Laboratory Comparison of Internal Quality Control Dataof Neonatal Disease Screening Indicators TSH and 17 alpha- OHPin 18 Newboring Screening Laboratory in Shandong Province
文章编号:
1671-7414(2019)02-140-05
作者:
周玉侠; 牛婷婷; 吴玉苏; 孙 岱
(山东省妇幼保健院,国家生育调控技术重点实验室,山东省优生技术重点实验室,济南 250014)
Author(s):
ZHOU Yu-xia; NIU Ting-ting; WU Yu-su; SUN Dai
(Maternal and Child Health Care Hospitalof Shandong Province,Key Laboratory of Birth Regulation and Control Technologyof National Health and Family Planning Commission of China,Key Laboratoryfor Improving Birth Outcome Technology of Shandong Province,Jina
关键词:
新生儿疾病筛查;  室内质量控制;  室间质量评价;  实验室间比对
分类号:
R722.1; R446
DOI:
10.3969/j.issn.1671-7414.2019.02.036
文献标志码:
A
摘要:
目的 应用新生儿疾病筛查数据分析与质量控制管理平台对山东省18家新生儿疾病筛查中心实验室的两项室内质控数据17羟孕酮(17α-hydroxyprogesterone,17α-OHP)和促甲状腺素(thyroid-stimulating hormone,TSH)进行室间比对分析。方法 17α-OHP和TSH的实验室检测方法为时间分辨免疫荧光法,并通过荧光分析仪计算出质控数据,质控数据由各实验室定期上传至山东省新生儿筛查数据分析与质量控制管理平台,最终应用此平台采集全省18家参评实验室的室内质控数据并进行分析。结果 17α-OHP低值质控测定数与变异系数(CV)、标准差指数(SDI)、变异系数指数(CVI)和总误差(TE)合格率分别为6 536,15.38%,100%,46.15%和100%; 相应高值质控分别为6 580,61.54%,100%,61.54%和100%。相应TSH低值质控测定数与CV,SDI,CVI和TE合格率分别为4 964,90.91%,90.91%,72.73%和100%; 相应高值质控分别为4 967,90.91%,100%,90.91%和100%。结论 通过对山东省18家新生儿疾病筛查实验室17α-OHP和TSH两项室内质控数据室间比对分析,可帮助各新生儿疾病筛查中心管理室内质控、统计分析数据、评价实验室的精密度和准确度,掌握各新生儿疾病筛查实验室质量控制现状,提高筛查质量。
Abstract:
Objective To analyse comparely Inter-laboratory of two internal quality control data 17α-hydroxyprogesterone(17α-OHP)and thyroid-stimulating hormone(TSH)of 18 neonatal disease screening centers in Shandong Province using neonatal disease screening data analysis and quality control management platform.Methods The laboratory detection methods of 17α-OHP and TSH were time-resolved immunofluorescence method,and the quality control data was calculated by the fluorescence analyzer.The qualitycontrol data was regularly uploaded by the laboratories to the newborn screening data analysis and quality control management platform,and the final application.This platform collected and analyzed the internal quality control data of 18participating laboratories.Results The number and qualified rates of CV,SDI,CVI,TE of 17α-OHP low control were 6 536,15.38%,100%,46.15% and 100%,respectively,and those of 17α-OHP high control were 6 580,61.54%,100%,61.54% and 100%,respectively,and those of TSH low control were 4 964,90.91%,90.91%,72.73% and 100%,respectively,and those of TSH high control were 4 967,90.91%,100%,90.91% and 100%,respectively.Conclusion Through the analysis of the internal quality control data of 18 neonatal disease screening laboratories 17α-OHP and TSH in Shandong Province,it can help each newborn disease screening center to manage internal quality control,statistical analysis data,and evaluation laboratory.Precision and accuracy,master the status of quality control in various neonatal disease screening laboratories,and improve screening quality.

参考文献/References:

[1] 国务院妇女儿童工作委员会.新生儿疾病筛查管理办法[S].中华人民共和国卫生部(第64号),2009.National Working Committee on Children and Women Under State Council.Newborn disease screening management measures[S].Ministry of Health of the People's Republic of China(No 64),2009.
[2] 王治国.临床检验质量控制技术[M].北京:人民卫生出版社,2014. WANG Zhiguo.Technology for quality control in cli-nical laboratory[M]. Bejing:People's Medical Publishing House,2014.
[3] 王治国,李小鹏,武平原.临床检验室内质量控制数据实验室间比对[J].中华检验医学杂志,2004,27(10):701-702. WANG Zhiguo,LI Xiaopeng,WU Pingyuan.Inter-laboratory comparisonof internal quality control data in clinical laboratory[J].Clin J Lab Med,2004,27(10):701-702.
[4] 杨伟,于瑞梅,张小涛,等.内分泌激素室内质量控制失控分析[J].检验医学与临床,2018,15(16):2520-2521,2524. YANG Wei,YU Ruimei,ZHANG Xiaotao,et al.Out of control analysis of internal quality control of endocrine hormone[J].Laboratory Medicine and Clinic,2018,15(16):2520-2521,2524.
[5] 段敏,王薇,赵海建,等.2018年全国临床检验质量指标室间质量评价结果分析及初步质量规范的制定[J].临床检验杂志,2018,36(12):931-936. DUAN Min,WANG Wei,ZHAO Haijian,et al.Analysis of external quality assessment for quality indicators in nationwide clinical laboratories during 2018 and establishment of preliminary quality specifications used in China[J].Chinese Journal of Clinical Laboratory Science,2018,36(12):931-936.
[6] 李婷婷,王薇,赵海建,等.临床实验室室间质量评价结果解释及不合格结果原因调查的建议性方法[J].现代检验医学杂志,2017,32(5):152-156. LI Tingting,WANG Wei,ZHANO Haijian,et al.In-terpretation of external quality assessment results in clinical laboratories and suggested approachon investigating unacceptable results[J].Journal of Modern Laboratory Medicine,2017,32(5):152-156.

相似文献/References:

[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.[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.[doi:10.3969/j.issn.1671-7414.2016.02.046]
[2]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.[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(02):154.[doi:10.3969/j.issn.1671-7414.2018.03.040]

备注/Memo

备注/Memo:
基金项目:山东省医药卫生科技发展计划(2013WS0126)。 作者简介:周玉侠(1975-),女,博士,副主任技师,研究方向:新生儿疾病筛查的质量管理,E-mail:zgzhouyuxia@163.com。 通讯作者:牛婷婷(1982-),女,硕士,主治医师,研究方向:新生儿疾病筛查,E-mail:sfbyniutt@163.com。 收稿日期:2019-01-28 修回日期:2019-03-10 页码：143+146
更新日期/Last Update: 2019-04-30