我国中孕期产前筛查不同检测系统室内质量控制现状与行业标准的比较  

Comparison of the Status of Internal Quality Control and Industry Standard of Different Platforms for Second Trimester Prenatal Screening in China

作　　者：何法霖[1] 王薇[1] 钟堃[1] 袁帅[1] 杜雨轩 王治国[1] HE Fa-lin;WANG Wei;ZHONG Kun;YUAN Shuai;DU Yu-xuan;WANG Zhi-guo(National Center for Clinical Laboratories /Beijing Engineering Research Center for Clinical Laboratory/National Center for Gerontology, Beijing Hospital, Beijing 100730, China)

机构地区：[1]北京医院国家老年医学中心卫生部临床检验中心/北京市临床检验工程技术研究中心,北京100730

出　　处：《现代检验医学杂志》2018年第1期154-157,160,共5页Journal of Modern Laboratory Medicine

基　　金：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)

摘　　要：目的通过分析中孕期产前筛查不同检测系统室内质控现状与行业标准的差异,为提高产前筛查质量控制提供建议。方法收集2016年全国468家产前筛查实验室9月份在控变异系数、累积在控变异系数,统计室内质控满足行业标准的比例,各检测系统组满足厂家要求及行业标准的比例。结果 AFP项目各检测系统满足厂家要求的实验室比例分布在34.9%~100%,满足行业标准要求的实验室比例分布在25.0%~78.0%;总HCG项目满足厂家要求的实验室比例分布59.2%~81.6%,满足行业标准要求的比例分布在24.5%~30.6%;freeβ-hCG项目各检测系统满足厂家要求的实验室比例分布在38.9%~100%,满足行业标准要求的实验室比例分布在27.3%~63.0%;β-hCG项目各检测系统满足厂家要求的比例分布在14.3%~68.8%,满足行业标准要求的比例分布在14.3%~61.3%;UE3项目各检测系统满足厂家要求的比例分布在19.7%~100%,满足行业标准要求的比例分布在11.1%~54.8%。结论不论何种检测系统都存在室内质量控制不满足行业标准的实验室,实验室需要重视室内质量控制,保证检测系统满足产前筛查质量要求。Objective To analyzed the differences between the status of internal quality control and industry standard of different platforms in second trimester prenatal screening,so as to provide recommendations to improve prenatal screening quality control.Methods Collected the coefficient of variation in control and accumulated coefficient of variation in control of468 prenatal screening laboratory in September 2016,and the proportion of the laboratory that meet the industry standard and analyze the proportion of different platforms that meet the manufacturers standards and industry standards.Results For AFP,34.9%-100% of the laboratory meeted the manufacturers standards and 25%-78% meet the industry standards;for total HCG,59.2%-81.6% of the laboratory meeted the manufacturers standards and 24.5%-30.6% meeted the industry standards,for freeβ-hCG,38.9%-100% of the laboratory meeted the manufacturers standards and 27.3%-63.0% meeted the industry standards,forβ-hCG,14.3%-68.8% of the laboratory meeted the manufacturers standards and 14.3%-61.3% meeted the industry standards.For uE3,19.7%-100% of the laboratory meeted the manufacturers standards and11.1%-54.8% meeted the industry standards.Conclusion Failure to meet the industry standards happens to all platforms.Prenatal screening laboratories need to pay attention to internal quality control to ensure the performance of the platforms meet the quality requirements of prenatal screening.

关 键 词：产前筛查 唐氏综合征 质量控制 

分 类 号：R446[医药卫生—诊断学]