摘要
目的调查我国产前筛查实验室妊娠中期血清学标记物中位数的现状，探讨质量控制的方法及重要性。方法2013年，参加卫生部临床检验中心妊娠中期母血清学产前筛查室间质量评价的实验室中，442个实验室回报了甲胎蛋白（α-fetalprotein，AFP）、人绒毛膜促性腺激素（humanchorionicgonadotropin，hCG）、β-hCG、游离β-hCG、游离雌三醇（unconjugatedestriol，uE，）中位数的相关信息。根据实验室所采用检测系统的厂商分组，使用美国PE、美国Beckman、广州丰华、瑞士罗氏、广州达瑞、德国西门子和美国雅培检测系统的实验室分别为170、120、31、26、13、11和9个。分析各实验室确定血清学标记物中位数的方式。根据各实验室上报的妊娠14～20周每周第3天的中位数，统计存在离群值的实验室个数。采用单个样本t检验，比较本研究结果与已发表文献的中国孕妇多中心研究结果。结果19．O％（84／442）的实验室自己确定妊娠中期母血清学产前筛查标记物的中位数；4．3％（19／442）与检测系统厂商共同确定中位数；76．7％（339／442）直接采用检测系统内嵌的中位数，其中97．9％（332／339）未对使用的中位数进行验证，84．3％（280／332）不知如何验证。各检测系统妊娠14～20周的AFP和uE，中位数随孕周升高，hCG、β-hCG和游离β-hCG中位数随孕周降低。美国PE系统的AFP、游离p—hCG和uE3的离群值均较多[分别为4．8％（50／1050）、6．8％（70／1029）和11.8％（85／721）]，且各孕周均有分布。广州丰华系统的AFP、广州达瑞系统的游离p—hCG、德国西门子系统的uE，离群值比例较高[分别为9．5％（20／210）、13．2％（12／91）和23．4％（18／77）]。本研究结果与多中心研究采用美国PE检测系统对我国汉族孕妇妊娠中期母血清学AFP和游离β-hCG中位数比较，妊娠14周和18周AFP中位数2组数�
Objective To investigate the current situation in application of median levels in second trimester in prenatal screening laboratory throughout China and to understand the methods and importance ofquality control. Methods Of those laboratories that participated in the national external quality assessment （EQA） for second trimester maternal serum screening in 2013, 442 submitted the medians for a-fetal protein （AFP）, human chorionic gonadotropin （hCG）, β -hCG, free β -hCG and unconjugated estriol （UE3） and related information. We categorized the medians according to the platform. There were 170, 210, 31, 26, 13, 11 and nine laboratories using the detection systems from Perkin Elmer, Beckman Coulter, Fenghua, Roche, Darui, Siemens and Abbott, respectively. The method of setting up the medians for each laboratory was analyzed. The number of laboratories, which was the outliers, was determined according to the reported medians on the third day of each week from 14th to 20th gestational weeks. Single sample t-test was applied to compare the result of this study with published results from a multi-center study of pregnant women in China. Results Among all laboratories, 19.0% （84/442） of the recruited laboratories setup the median on their own. And 4.3% （19/442） did this with their vendors; 76.7% （339/442） used the default median from the software, among them 97.9% （332/339） did not verify their medians and 84.3% （280/332） had no idea of how to do. Medians of AFP and uE3 increased with gestational age, while medians of hCG, β -hCG and free β -hCG decreased in all detection systems. More outliers were found for AFP, free 13 -hCG and uE3 medians in Perkin Elmer system, which scattered in each gestational age. A higher proportion of AFP in Fenghua system, free β -hCG in Darui system and uE3 in Siemens system were reported [9.5% （20/210）, 13.2% （12/91） and 23.4% （18/77）, respectively]. The medians of AFP and β -hCG using Perkin Elmer platform were compared between this st
出处
《中华围产医学杂志》
CAS
CSCD
2015年第10期761-765,共5页
Chinese Journal of Perinatal Medicine
基金
基金项目：北京市自然科学基金（7143182）
关键词
妊娠中期
甲胎蛋白类
绒毛膜促性腺激素
Β亚单位
人
产前诊断
生物学标记
质量控制
Pregnancy trimester, second
alpha-Fetoproteins
Chorionic gonadotropin, beta subunit, human
Prenatal diagnosis
Biological markers
Quality control
