摘要
目的 总结分析2004至2013年全国中孕期母血清产前筛查室间质量评价的实验室结果,为提高产前筛查质量提供参考.方法 2004至2013年卫生部临检中心每次室间质量评价活动发放5个不同浓度的质控品,要求各产前筛查实验室检测并在规定的时间内回报结果,评价实验室检测甲胎蛋白（AFP）、人绒毛膜促性腺激素（HCG）、人绒毛膜促性腺激素β-亚基（β-HCG）、人绒毛膜促性腺激素游离β-亚基（freeβ-HCG）、未结合雌三醇（uE3）的能力.结果 2004至2013年参加实验室数量从57家增加到500家;AFP的稳健变异系数2.77％ ～ 18.98％,HCG稳健变异系数5.6％～36.12％,β-HCG稳健变异系数4.69％ ～ 24.38％,freeβ-HCG稳健变异系数2.66％ ～ 81.54％,uE3稳健变异系数3.83％ ～26.51％;AFP的合格率93％ （463/496）,HCG的合格率66％（35/53）,β-HCG合格率85％（137/161）,free β-HCG（μg/L）的合格率从52％（24/46）增加到94％（248/264）,free β-HCG（mIU/ml）的合格率为47％ （18/38）,uE3的实验室合格率达84％（252/299）.结论 中孕期产前筛查AFP项目检测水平较好,其次为β-HCG项目,其他项目仍存在一定问题,我国仍需重视室间质量评价、建立全面的质量控制体系提高中孕期母血清产前筛查的检测水平.
Objective To summarize and analyze the results of national external quality assessment （EQA） of maternal serum prenatal screening in second trimester during 2004-2013,in order to provide a assistance for the quality improvement of the prenatal screening testing.Methods Five different concentration samples were distributed to each participated laboratories and were measured at each external quality assessment program during 2004 to 2013.The results reported in a specified time.The testing performance of alpha fetoprotein （AFP）,total human chorionic gonadotropin （HCG）,total β-human chorionic gonadotropin （β-HCG）,free β-human chorionic gonadotropin （free β-HCG）,unconjugated estriol （uE3） were evaluated.Results During 2004-2013,the number of laboratory participated increased from 57 to 500.The robust variation coefficient increased from 2.77% to 18.98% for AFP,5.6% to 36.12% for HCG,4.69% to 24.38% for β-HCG,2.66% to 81.54% for free β-HCG,and 3.83% to 26.51% for uE3.The percentage of passing rate reached 93% （463/496） for AFP,66% （35/53）for HCG,85% （137/ 161） for β-HCG.The percentage of passing of free β-HCG （μg/L） increased from 52 % （24/46） to 94% （248/264）,but the passing percentage of free β-HCG （mIU/ml） were 47% （18/38）.The percentage of passing of uE3 reached 84% （252/299）.Conclusions The testing performance of AFP is best in prenatal screening,followed by β-HCG,other item testing have some problems.It is great important to improve the quality of maternal serum prenatal screening by strengthening external quality assessment and building comprehensive quality control system in China.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2014年第4期270-275,共6页
Chinese Journal of Laboratory Medicine
关键词
妊娠中期
产前诊断
甲胎蛋白类
Pregnancy trimester,second
Prenatal diagnosis
alpha-Fetoproteins
