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目的对比国产孕中期产前筛查系统与进口孕中期产前筛查系统的差异。方法随机收集临床上进行产前筛查的14-21周孕妇血清(常规静脉采血,不抗凝)643份,分别用PerkinElmer公司(进口)时间分辨免疫荧光测定系统(AFP+Freeβ-HCG)及安图生物(国产)化学发光测定系统(P-AFP+Freeβ-HCG)同时对血清标志物进行测定,对比两种检测系统对血清标志物检测结果的相关性及风险分析的一致性。结果两种产前筛查系统在血清标志物的测定方面,相关系数R均高于0.97,在神经管缺陷的风险判断方面符合率为99.8%,在唐氏综合征方面风险判断符合率为99.2%。结论两种检测系统之间呈现出良好的相关性,在风险判断方面差异无统计学意义(P>0.05)。
Objective To compare the differences of the prenatal screening system in the second trimester of pregnancy with the prenatal screening system in the second trimester of pregnancy. Methods A total of 643 pregnant women (14-25 weeks old) with prenatal screening of 14-21 weeks prenatal screening were randomly collected. PerkinElmer’s time-resolved immunofluorescence assay system (AFP + Freeβ-HCG) and Simultaneous determination of serum markers by Antares Bio-Chemiluminescence Assay (P-AFP + Freeβ-HCG) compared the correlation between the two detection systems for serum markers and the consistency of risk analysis. Results The two prenatal screening systems had a correlation coefficient R higher than 0.97 in the determination of serum markers and a coincidence rate of 99.8% in judging the risk of neural tube defects and 99.2 in risk assessment of Down’s syndrome %. Conclusion There is a good correlation between the two detection systems and no significant difference in risk judgment (P> 0.05).