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目的探讨提高苏州地区唐氏综合征孕中期二联筛查筛查准确性的方法。方法使用全自动实验仪器Auto Delfia 1235,并与半自动的Delfia 1420比较批间CV%;规范标本采集、递送等分析前的实验操作,比较各采血中心筛查阳性率变化情况;利用Lifecycle3.0计算本地中位数方程,通过累积和图法与lifecycle内置中位数进行统计学比较分析。结果使用全自动实验仪器Auto Delfia 1235后,批间CV%由8%以内降低为5%以内;规范标本采集、递送等分析前实验操作后,解决了个别采血中心阳性率偏高的问题,大部分各采血中心的筛查阳性率都控制在了6%以内,筛查总阳性率在5%左右;使用本地中位数方程后,孕中期孕妇甲胎蛋白和游离人绒毛膜促性腺激素的累积和图在0附近,而使用Lifecycle3.0内置中位数游离人绒毛膜促性腺激素的累积和图偏离0。结论使用全自动的实验仪器,规范标本采集、递送等分析前的实验操作,并使用本地中位数方程能有效地提高筛查准确性。
Objective To explore a method to improve the screening screening accuracy in the second trimester of Down’s syndrome in Suzhou area. Methods Auto Delfia 1235 was used in the experiment and compared with the semi-automatic Delfia 1420. The pre-analysis experiment was conducted to collect samples and deliver samples, and the positive rate of each screening center was compared. Lifecycle 3.0 was used to calculate The local median equation was statistically analyzed by means of cumulative sum plot method and lifecycle built-in median. Results After using Auto Delfia 1235, the CV% of batches decreased from less than 8% to less than 5%. After the pre-analysis experiment such as collecting and delivering samples, the problem of high positive rate of individual blood collection centers was solved. Large Part of the blood collection center of screening positive rate were controlled within 6%, the total positive screening rate of about 5%; using the local median equation, the second trimester pregnant women with alpha-fetoprotein and free human chorionic gonadotropin Cumulative and plot around 0, while using Lifecycle 3.0 built-in median free human chorionic gonadotropin accumulation and plot deviations from zero. Conclusion The automatic experimental equipment is used to standardize the pre-analysis operation such as sample collection and delivery, and the local median equation can effectively improve the screening accuracy.