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。
Objective To analyse comparely Inter-laboratory of two internal quality control data 17α-hydroxyprogesterone(17α-OHP)and thyroid-stimulating hormone(TSH)of 18neonatal 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 quality control 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 18neonatal 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.
作者
周玉侠
牛婷婷
吴玉苏
孙岱
ZHOU Yu-xia;NIU Ting-ting;WU Yu-su;SUN Dai(Maternal and Child Health Care Hospital of Shandong Province,Key Laboratory of Birth Regulation and Control Technology of National Health and Family Planning Commission of China,Key Laboratory for Improving Birth Outcome Technology of Shandong Province,Jinan 250014,China)
出处
《现代检验医学杂志》
CAS
2019年第2期140-143,146,共5页
Journal of Modern Laboratory Medicine
基金
山东省医药卫生科技发展计划(2013WS0126)
