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目的探讨广州丰华与芬兰珀金埃尔默产前筛查分析系统的可比性。方法随机选取孕14-20+6周的孕妇180例,分别用广州丰华TALENT-Ⅱ型和芬兰Wallac Vitro2D-1420型仪器及配套试剂检测F-βHCG、h-AFP浓度,进而根据其浓度用相应配套的分析软件评估胎儿患唐氏综合征的风险。记录检测及分析的结果,经统计学分析处理后,观察两者的差异。结果AFP浓度值的相关系数r=0.9986(或R2=0.9972),F-βHCG浓度值的相关系数r=0.9984(或R2=0.9969),χ2=0.67,P>0.05。结论实验方法和比较方法之间显示良好的相关性,两风险软件对高风险孕妇检出率的差异无统计学意义。
Objective To investigate the comparability of prenatal screening analysis system between Fenghua, Guangzhou and PerkinElmer, Finland. Methods A total of 180 pregnant women with gestational age 14-20 + 6 weeks were enrolled in this study. The concentrations of F-βHCG and h-AFP were detected by using the Fenghua TALENT-Ⅱ and Finnish Wallac Vitro2D-1420 instruments, respectively. The concentrations of F- The corresponding analytical software to assess the risk of fetal Down Syndrome. Record the results of testing and analysis, after statistical analysis and processing, observe the difference between the two. Results Correlation coefficient of AFP concentration was 0.9986 (or R2 = 0.9972). The correlation coefficient of F-βHCG concentration was 0.9984 (or R2 = 0.9969), χ2 = 0.67, P> 0.05. Conclusion There is a good correlation between the experimental method and the comparative method. There is no significant difference between the two risk softwares on the detection rate of high-risk pregnant women.