广州市早孕期产前筛查血清学指标中位数本地化的效果

Effect of localization of serological indicators in prenatal screening of early pregnancy in Guangzhou

目的探讨广州市早孕期产前筛查血清学指标中位数本地化的效果。方法选取广州市妇女儿童医疗中心行早孕期筛查的单胎妊娠孕妇共56977例为研究对象,建立广州地区不同孕周、体重条件下各血清学指标浓度中位参考值和风险计算公式。进一步对2016年11月21日至2018年12月31日间单胎妊娠孕妇共60637例进行数据本地化后的风险评估,分析数据本地化后血清学指标中位数的倍数(multiples of the median,MoM)值的变化趋势、筛查阳性率和检出率,评价血清学指标中位数本地化后的筛查效率。结果采用软件内置数据计算的freeβ-hCG MoM和PAPPA MoM值中位数分别比本地化后中位数高26.67%和17.31%,数据本地化前不同孕周、不同体重条件下free β-hCG MoM和PAPPA MoM值中位数均偏高,数据本地化后free β-hCG MoM和PAPPA MoM值中位数保持稳定。数据本地化后DS筛查阳性率低于数据本地化前,总检出率和DS检出率高于数据本地化前,差异均无统计学意义(P>0.05);数据本地化后18-三体综合征检出率高于数据本地化前,差异有统计学意义(P<0.05)。结论数据本地化后有利于降低产前筛查阳性率和羊水穿刺率,提高DS和18-三体综合征检出率。建立以血清学指标MoM值中位数为依据的质量控制体系,根据MoM值中位数的变化判断内设本地数据的合理性及调整时机,有利于提高本实验室产前筛查的质量。

Objective To investigate the effect of localization of serological indicators of prenatal screening of early pregnancy in Guangzhou.Methods A total of 56977 cases of Guangzhou pregnant women who underwent early pregnancy screening were selected.The median reference value and risk calculation formula of serum index concentrations under different gestational weeks and body weight were established.Furthermore,60637 single pregnancy pregnant women from November 21,2016 to December 31,2018 were analyzed for the risk assessment after data localization.The change trend of multiple of the median(MoM)value,positive rate and detection rate of serological indicators after localization were analyzed,and the screening efficiency after localization of median serological indicators was evaluated.Results The median values of free β-hCG MoM and pappa MoM calculated by software built-in data were 26.67% and 17.31%,respectively,significantly higher than those after localization.Before data localization,the median values of free β-hCG MoM and pappa MoM were higher under different gestational weeks and body weight.After data localization,the median values of free β-hCG MoM and pappa MoM remained stable.The positive rate of DS screening after data localization was lower than that before data localization,the total detection rate and DS detection rate were higher than those before data localization,but the difference was not statistically significant.The detection rate of trisomy 18 syndrome after data localization was significantly higher than that before data localization(P<0.05).Conclusion The localization of the data can reduce the positive rate of prenatal screening and amniocentesis rate,and improve the detection rate of DS and trisomy 18 syndrome.The establishment of a quality control system based on the serological index mMoM value,judging the rationality of the internal local data and adjusting the opportunity according to the change of the MoM value is conducive to improving the quality of prenatal screening in our laboratory.