【摘要】 目的:采用产前筛查指标中位数倍数值(MoM)中位数(即mMoM)评价质控体系,对各指标mMoM进行监测和必要的修正,以使唐氏综合征产前筛查系统保持在良好的检出率和假阳性率水平。方法:选取北京协和医院产前筛查实验室2009年7月1日至2013年2月28日完成的所有符合入组要求的孕中期三联筛查数据共26415例,在预设监测及修正条件的基础上进行了甲胎蛋白(AFP)、游离人绒毛膜促性腺激素β亚基(F-β-HCG)和非结合雌三醇(uE3)的mMoM时间轴回顾性纵向分析。将上述指标在纵向监测的基础上根据预设条件进行了必要的中位数修正,重新计算分析所有病例的风险评估和筛查整体效率。结果:经过分析和调整,所有指标的mMoM都实现了0.95~1.05的长期稳定,唐氏综合征假阳性率下降1%(5.9%vs4.9%),唐氏综合征检出率(75%)虽然保持不变,但确诊阳性病例呈现整体风险值增高的趋势。结论:基于筛查指标mMoM值的评价质控体系可以灵敏地发现偶发的偏倚因素,并结合预设规则进行中位数的修正,较好地消除了系统误差的持续作用。降低假阳性率、确保检出率水平的稳定,是唐氏综合征产前筛查工作一个有效的质控技术体系。更多还原

【Abstract】 βObjective: By adopting the audit system of medianvalues of MoM in prenatal screening,the median values of several indexes were monitored and corrected necessarily to keep the detection rate and false positive rate at an appropriate level. Methods: From July 1,2009 to February 28,2013,26415 cases of Chinese singleton pregnancies with second trimester prenatal screening in Peking Union Medical College Hospital were enrolled. The mMoM of the screening markers of AFP（ alpha-fetoprotein）,Free-β-HCG（ freehuman chorionicgonadotropinβ subunit）,uE₃（ unconjugated estriol） were audited by a longitudinal analysis. Acoording to the analysis results,the median values of the aforementioned indexes were revised necessarily,the risk estimation and the total screening efficiency were recalculated and analyzed. Results: After analysis and adjustment,the median MoMs value of all indicators have achieved long-term stability within 0. 95 1. 05,the false positive rate decreased by 1%（ 5. 9% vs 4. 9%）,although the detection rate（ 75%） remained unchanged, but confirmed positive cases showed an increasing trend on overall risk value. Conclusions: The evaluation system based on median MoMs value of the screening marker is very sensitive in detecting bias raised from incidentalfactors. And combined with the preset rules on median correction,the audit system can be a very good way to eliminate the system error which play a role continuously,reduce the false positive rate and ensure the stable level of detection rate. This audit method is an effective prenatal screening quality control technology system.更多还原