两种产前血清学筛查系统的可比性研究

Comparative analysis of the two prenatal serological screening systems

目的:探讨两种检测系统对血清学产前筛查标志物甲胎蛋白(AFP)、游离β-人绒毛膜促性腺激素(free-β-HCG)检测结果的可比性和唐氏综合征筛查检出率,评价两种系统筛查结果是否具有一致性。方法:选取60例中孕期妇女血清标本,分成2份,分别利用广州丰华TALENTⅡ型筛查系统和PE公司Auto DELFIA1235筛查系统进行血清标记物AFP和free-β-HCG的检测,利用系统自带的筛查软件分别计算评估胎儿患唐氏综合征的风险值,并对结果进行统计分析。结果:两种筛查系统测定AFP、free-β-HCG的结果经配对t检验,差异有统计学意义(P<0.001),两系统检查结果的相关系数(r)均>0.985(P<0.001),偏倚在允许范围。两种系统唐氏综合征筛查阳性结果按临界风险、高风险分丰华系统为9例和5例,PE系统为13例和5例,经秩和检验差异无统计学意义(P>0.05)。两种筛查系统对唐氏综合征的检出率,丰华为2例,PE为3例,经McNemar χ~2检验差异无统计意义(P>0.05)。结论:两种筛查系统尽管检测方法原理不尽相同,但筛查结果基本一致,本科室使用的国产血清学筛查系统能满足临床需要。

Objective:To evaluate the comparability,consistency and positive detection rate of test results of human serumαfetoprotein(AFP)and freeβHuman chorionic gonadotropin(HCG)by two detection systems in screening Down′s syndrome.Methods:The serum samples collected from60women in middle pregnancy were randomly divided into two groups.Samples in one group were detected with TALENT II system manufactured by Guangzhou Fenghua Biotechnology Co.Ltd(Fenghua system),and those in another with AutoDELFIA1235system supplied by Finland Perkin Elmer Wallac(PE system).Both the AFP and freeβHCG levels were measured and calculated with the software equipped with the system itself to estimate the risk values of Down′s syndrome,and the results were statistically analyzed.Results:Paired t test indicated difference between the two systems concerning the measured serum AFP and freeβHCG levels(P<0.001).The correlation coefficient(r)was>0.985,yet the bias was within allowable scope.The critical and high risks for Down′s syndrome were9and5cases,13and5cases respectively by Fenghua system and the PE system,with no significant difference by rank sum test(P>0.05).Fenghuan system and PE system revealed Down′s syndrome in2and3cases,respectively,yet the difference was not significant by McNemar′s test(P>0.05).Conclusion:The two kinds of screening system are different in principles,yet the two systems can lead to similar results,suggesting that the domestic instrument used in our laboratory may meet the clinical needs in prenatal screening.