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目的研究唐氏综合征孕中期三联筛查模型的区域性参数。方法利用Auto DELFIA全自动时间分辨荧光免疫分析仪和作三联筛查Lifecycle 3.2软件,对金华市20 232名孕中期(孕周在15~20+6周)单胎孕妇作血清AFP、freeβ-h CG、u E3浓度检测和唐氏综合征三联筛查,将AFP、freeβ-h CG、u E3的检测结果 (中位数)作为区域性参数取代Lifecycle 3.2软件中模型内置的这三项中位数参数,再作三联筛查,并以染色体分析和出生后随访为金标准,对两者筛查的效果作比较。结果金华市孕妇各标志物中位数水平比软件内置高加索人群中位数水平高,配对U检验显示差异有统计学意义(P<0.01);采用金华市与软件内置两组中位数重新计算风险,两者真阳性的检出率(灵敏度)均为87.50%;采用金华市中位数筛查的假阳性率为4.24%,而内置中位数假阳性率为4.74%。结论 Lifecycle 3.2软件筛查唐氏儿采用的中位数参数存在种族与地域差异,釆用金华本地中位数参数可降低该地区的假阳性率,但是用软件内置中位数参数值作筛查尚适用于金华地区。
Objective To study the regional parameters of triple screening in the second trimester of Down Syndrome. Methods Auto-DELFIA automatic time-resolved fluorescence immunoassay analyzer and triple-screen Lifecycle 3.2 software were used to analyze serum levels of AFP, freeβ-h in 20 232 pregnant women (15-20 + 6 weeks) CG, uE3 concentration test and Down’s syndrome triple screening, the detection results (median) of AFP, free beta-hGc, uE3 as a regional parameter instead of the three built-in model of Lifecycle 3.2 software Number of parameters, and then for triple screening, and chromosome analysis and follow-up after birth as the gold standard, comparing the effectiveness of the two screening. Results The median level of pregnant women in Jinhua was higher than that in the software-built Caucasians, and the paired U-test showed significant difference (P <0.01). The median of Jinhua and software was recalculated Risk, true positive detection rate (sensitivity) of both were 87.50%; using the median of Jinhua screening false positive rate was 4.24%, while the built-in median false positive rate was 4.74%. Conclusion There is racial and geographical differences in the median parameters used by Down’s syndrome screening software in Lifecycle 3.2 software. The median of Jinhua’s median medications can be used to reduce the false-positive rate in the region, but the software median median is used for screening Still suitable for Jinhua area.