纸血片AFP及Β-HCG检测用于唐氏综合征的产前筛查

Second-trimester alpha-fetoprotein and beta-human chorionic gonadotrophin prenatal screening using dried blood spots on filter paper for Down's syndrome

目的检测纸血片中AFP及Β-HCG,探讨该方法用于唐氏综合征产前筛查的可行性。方法采用标准双抗体夹心ELISA方法检测AFP及Β-HCG,对164例不同孕周孕妇纸血片及血清标本同时进行对比试验。结果血清与纸血片2种方法的相关系数>0．92,呈高度相关。根据2种方法检测结果,通过优普生软件计算各标本的危险系数,以<1／500为需进一步进行相应检查的高危人群,2种方法检测均为高危人群者14例,均为非高危人群145例,2种方法一致总例数为98．9％(159／161),其中2例不符,均在临界值附近。血片稳定性好,在4℃贮存3个月后检测AFP和HCG,其回收率分别为100．4％和94．2％,批内变异系数(CV)<10％,批间VC <15％。结论测定纸血片中AFP及Β-HCG与用血清进行检测结果一致性高,都可用于唐氏综合征产前筛查。

Objective To establish a laboratory method to determine alpha-fetoprotein（AFP） and beta-human chorionic gonadotrophin （β-HCG） using dried blood spots on filter paper and to estimate the efficacy for second-trimester Down＇s syndrome prenatal screening. Methods AFP and β-HCG were detected by antibody sandwich enzyme-linked immunosorbent assay （ELISA）. AFP and β-HCG in serum specimen and samples of dried blood spots on filter paper of were detected in 164 women of 14 to 20 gestational weeks in Baoan District of Shenzhen using the ELISA assay kit provided by PuRingTaiKe Co. Results Compared with the 164 serum samples with ELISA assay, all the correlation coefficients （r） were over 0.92, indicating a good correlation. According to two method examination results, their risk coefficients were calculated with the professional software ＂YOUPUSHENG＂. In two methods, all have 14 with high risk for Down＇s syndrome, and 145 women with low risk for Down＇s syndrome, indicating a concordance of 159 out of 161 （98.6 %）. No significant was noted in the results after the dried blood spots on filter paper were saved at 4 degrees centigrade for 3 month. The recovery rate of AFP of dried blood spots on filter paper was 100.4 %, and β-HCG was 94.2 %, with an intraassay coefficient of variation of〈10 %, and an interassay coefficient of variation of 〈 15 %. Conclusion Second-trimester AFP and β-HCG using dried blood spots on filter paper can used for prenatal screening for Down＇s syndrome.