Lamlertkittikul Surachai, Chandeying Verapol
Department of Obstetrics and Gynecology, Hat Yai Regional Hospital, Hat Yai, Songkhla, Thailand.
J Med Assoc Thai. 2007 Oct;90(10):1970-6.
To summarize the experience and evaluate the performance of the Hat Yai maternal serum screening (MSS) program.
The Hat Yai MSS program between 16 February 2003 and 11 March 2004.
The uptake of screening was 999 in 1,040 women (96.0%), between 14 to 20 weeks of gestation with the triple markers: Alpha-fetoprotein (AFP), human Chorionic Gonadotropin (hCG), and unconjugated Estriol (uE3) by Immulite chemiluminescent immunoassay system, Diagnostic Product Corporation (DPC). The risk cut-off for Down 's syndrome is one in 250 or greater, based on software for prenatal Down's syndrome risk calculation, by Prisca 3.5 DPC.
There were 119 in 999 cases (11.9%) of the triple test positive. Amniocentesis had been performed on voluntary basis, and the uptake rate of amniocentesis following a positive Down's syndrome screening was 104 in 119 cases (87.3%). Based on clinical diagnosis of Down's syndrome in the newborns of non-amniocentesis mothers, assuming that normal looking babies were not Down's syndrome, the sensitivity (SENS), specificity (SPEC), positive predictive value (PPV), and negative predictive value (NPV) of all chromosomal abnormalities were 85.7%, 88.6%, 5.0%, and 99.8% respectively. The false positive rate was 113 in 992 cases (11.4%). Whereas, the SENS, SPEC, PPV and NPV of Down's syndrome were 100%, 88.4%, 3.4%, and 100% respectively. The false positive rate was 115 in 995 cases (11.6%). The mean level, median level, and multiple of median (MoM) of triple markers were demonstrated.
The Down's syndrome screening is a systematic application of a test to identify subjects at increased risk of a specific disorder; of course it is not diagnostic, but to benefit making decision regarding further amniocentesis. The sensitivity of Prisca 3.5 software was satisfactory but false positive rate was remarkably high. It needs further standardization with adjusted MoM values.
总结合艾母血清筛查(MSS)项目的经验并评估其性能。
2003年2月16日至2004年3月11日期间的合艾MSS项目。
1040名孕妇中有999人(96.0%)接受了筛查,孕周为14至20周,采用Diagnostic Product Corporation(DPC)的Immulite化学发光免疫分析系统检测三联标志物:甲胎蛋白(AFP)、人绒毛膜促性腺激素(hCG)和未结合雌三醇(uE3)。根据DPC的Prisca 3.5软件进行产前唐氏综合征风险计算,唐氏综合征的风险截断值为1/250或更高。
999例中有119例(11.9%)三联检测呈阳性。羊膜穿刺术为自愿进行,唐氏综合征筛查呈阳性后羊膜穿刺术的接受率为119例中的104例(87.3%)。根据未进行羊膜穿刺术母亲所生新生儿的唐氏综合征临床诊断,假设外观正常的婴儿不是唐氏综合征,所有染色体异常的敏感性(SENS)、特异性(SPEC)、阳性预测值(PPV)和阴性预测值(NPV)分别为85.7%、88.6%、5.0%和99.8%。假阳性率为992例中的113例(11.4%)。而唐氏综合征的SENS、SPEC、PPV和NPV分别为100%、88.4%、3.4%和100%。假阳性率为995例中的115例(11.6%)。展示了三联标志物的平均水平、中位数水平和中位数倍数(MoM)。
唐氏综合征筛查是一种系统应用的检测方法,用于识别特定疾病风险增加者;当然它不是诊断性的,而是有助于做出关于进一步羊膜穿刺术的决策。Prisca 3.5软件的敏感性令人满意,但假阳性率非常高。需要通过调整MoM值进一步标准化。