[1]何法霖,王 薇,钟 堃,等.2015年全国中孕期母血清产前筛查相关指标的调查与分析[J].现代检验医学杂志,2017,32(01):154-156,164.[doi:10.3969/j.issn.1671-7414.2017.01.043]
　HE Fa-lin,WANG Wei,ZHONG Kun,et al.Survey and Analysis for Maternal Serum Marker of Prenatal Screening in Second Trimester in 2015[J].Journal of Modern Laboratory Medicine,2017,32(01):154-156,164.[doi:10.3969/j.issn.1671-7414.2017.01.043]
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2015年全国中孕期母血清产前筛查相关指标的调查与分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年01期
页码:
154-156,164
栏目:
质量控制·实验室管理
出版日期:
2017-01-25

文章信息/Info

Title:
Survey and Analysis for Maternal Serum Marker of Prenatal Screening in Second Trimester in 2015
文章编号:
1671-7414(2017)01-154-04
作者:
何法霖; 王 薇; 钟 堃; 袁 帅; 王治国
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
Author(s):
HE Fa-lin; WANG Wei; ZHONG Kun; YUAN Shuai; WANG Zhi-guo
National Center for Clinical Laboratories/Beijing Engineering Research Center for Clinical Laboratory,Beijing Hospital,National Center for Gerontology,Beijing 100730,China
关键词:
产前筛查;  质量控制;  中位数倍数
分类号:
R714.7; R446
DOI:
10.3969/j.issn.1671-7414.2017.01.043
文献标志码:
A
摘要:
目的 调查全国477家产前筛查实验室半年的数据,分析产前筛查现状,为质量控制提供建议。方法 要求参加2015年全国中孕期母血清产前筛查室间质量评价计划的实验室回报目前使用的风险软件名称,阳性截断值,每月的标本数量,AFP,HCG,β-HCG,free β-HCG,uE3项目MOM中位数(mMOM),每个月筛查21-三体,18-三体和神经管缺陷的阳性率,并对各个指标进行统计分析。结果 ①筛查方案多样:73.48%(133/181)实验室使用二联筛查,24.31%(44/181)实验室使用三联筛查,2.21%(4/181)实验室使用四联筛查。②风险软件情况:350家实验室没有修改过风险软件参数,89家实验室参数是由厂家修改,24家实验室参数由该实验室修改。③21-三体,18-三体和神经管缺陷截断值使用不一致:59.91%(275/459)实验室21-三体风险截断值为1/270,66.22%(296/447)实验室18-三体风险截断值为1/350。96.52%(361/374)实验室神经管缺陷MOM截断值分布在2～2.5。④各指标mMOM的情况:AFP,HCG,β-HCG,free β-HCG,uE3 mMOM 6个月都在0.90～1.10内的百分数分别为46.69%(155/332),20.0%(4/20),29.17%(28/96),15.66%(31/198)和4.82%(11/228),6个月都在0.95～1.05范围内的百分数分别为14.16%(47/332),0%(0/20),4.17%(4/96),12.63%(25/198)和4.82%(11/228)。⑤阳性率情况:21-三体阳性率最高,其次为神经管缺陷阳性率,最少的为18-三体阳性率。各实验室21-三体各月之间的阳性率变化差异不一致。结论 目前产前筛查实验室筛查方案多样、技术平台不一、重要的参数选择随意、质量控制良莠不齐,单一使用某一个质量指标进行评判很难发现实验室问题,使用多个质量指标进行产前筛查实验室的质量控制是一种适合国情且行之有效的方法。
Abstract:
Objective To investigate the dates of 477 Chinese prenatal screening centers for previous half year analyse prenatal screening status and provide recommendations for quality control.Methods All China prenatal screening centers were sent the data via the National Quality Assessment Scheme.This covered the software used,the risk cut-offs,monthly sample throughput,monthly median MoM of AFP,hCG,β-HCG,free β-HCG and uE3,monthly screening positive rate for trisomy 21,trisomy 18 and Open Neural Tube Defect.Results Screening protocol were versatile,with 73.48%(133/181)used two-marker model,24.31%(44/181)used three-marker model and 2.21% used four-marker model.About the software used,350 laboratories never updated the screening parameters,89 laboratories had updated their median or parameter by manufacturers,24 laboratories had updated the parameters by themselves.Cut-offs differed between laboratories.59.91%(275/459)used 1/270 as their cutoffs for trisomy 21.66.22%(296/447)used 1/350 as their cutoff for trisomy 18 and 96.52%(361/374)used cutoffs between 2.0～2.5 MOM for ONTD.Results of monthly median MOM:the percentage of laboratories that all six monthly median MOM within the target of 0.90～1.10 was 46.69%(155/332)for AFP,20.0%(4/20)for hCG,29.17%(28/96)for β-HCG,15.66%(31/198)for free β-HCG and 4.82%(11/228)for uE3.The percentage of laboratories that all six monthly median MOM within the target of 0.95～1.05 was 14.16%(47/332)for AFP,0%(0/20)for hCG,4.17%(4/96)for β-HCG,12.63%(25/198)for free β-HCG and 4.82%(11/228)for uE3.About screening positive rate,there were difference of trisomy 21 positive rate in the same laboratory within the six month.Conclusion There were variations types of screening protocol,different kinds of soft platform,randomness of choice or update of medians or other important parameters and great difference in awareness of quality control.It would be taken effective and practical quality control measures to help laboratories improve quality control.

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备注/Memo

备注/Memo:
作者简介:何法霖(1981-),女,硕士,助理研究员,从事实验室质量控制与管理,Tel:18611385201,E-mail:hefalin@126.com。
通讯作者:王治国(1964-),男,教授,硕士生导师,研究方向:实验室质量控制与管理,Tel:010-58115055,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 2017-01-20