广东省中山地区孕早期血清F-βHCG和PAPP-A水平中位数系统的建立及对唐氏综合征产前筛查的监测与相关性分析

Establishment of Median System of Serum Markers F-βHCG and PAPP-A for Prenatal Screening in Early Pregnancy and Monitoring of Prenatal Screening and Analysis of the Correlation for Down’s Syndrome in Zhongshan of Guangdong Province

目的探讨广东中山地区孕早期产前筛查血清标志物游离β人绒毛膜促性腺激素(F-βHCG)和妊娠血清相关蛋白-A(PAPP-A)中位数系统的建立及对唐氏综合征产前筛查的监测与相关性分析。方法采用IMMULITE2000全自动化学发光免疫分析系统对11566例孕63~97天孕妇进行F-βHCG和PAPP-A浓度检测,采用SPSS 19.0软件进行统计分析,通过加权回归分析法构建中山地区孕早期血清标志物中位数曲线方程及体重校正曲线方程;采用配对t检验进行中山地区数据与Prisca4软件内置数据进行比较。结果建立了中山地区人群模型的孕早期血清标志物中位数系统,中山地区的F-βHCG浓度中位数均高于软件内置中位数,平均高出7%;中山地区的PAPP-A浓度中位数均低于软件内置中位数,平均低出13%;中山地区人群模型所得的中位数倍数值中位值(mMOM)稳定在0.95~1.05范围内,假阳性率为5.0%。结论建立的中山地区孕早期孕妇血清标志物中位数系统更符合该地区人群特点,更能提高该实验室产前筛查的质量。

Objective To establish a median system of serum markers F-βHCG and PAPP-A for prenatal screening in early pregnancy and monitoring of prenatal screening and analysis of the correlation for Down’s syndrome in Zhongshan of Guangdong Province.Methods Used IMMULITE2000 automatic chemiluminescence immunoassay system to detect the concentration of F-βHCG and PAPP-A of 11566 pregnant women(gestational days:63~97 days),and used SPSS19.0 software to analyze all the data.Used the weighted regression analysis method to establish the early pregnancy serum marker median equation and the weight calibration equation of Zhongshan,and used paired t-test to compare the data of Zhongshan with the built-in data of the Prisca4 risk evaluation’s software.Results The serum marker median system in early pregnancy of crowd model in Zhongshan was established.The median F-βHCG concentration of Zhongshan was 7%,higher than the software built-in average,and the median PAPP-A concentration of Zhongshan was 13%,lower than the software built-in average.The mMOM obtained by the median system of crowd model in Zhongshan was stable in the range of 0.95 to 1.05,and the false positive rate was 5.0%.Conclusion The median system of serum markers of pregnant women in early pregnancy in Zhongshan region established is more in line with the characteristics of local population,which is conducive to improving the quality of prenatal screening.