目的：探讨基于患者标本的孕中期血清三联唐氏综合征产前筛查自动化校正方案,旨在建立更有效的唐氏综合征产前筛查质量保证体系。方法：对本院2014年的13 024例孕中期孕妇的唐氏征筛查中位数倍数（multiple of medians, MoM）,运用累积和批次校正法进行校正,采用校正中位数倍数中值（median of multiple of medians, mMoM）在0.90~1.10之外的批次（方案一）和校正中位数倍数中值（mMoM）在0.95~1.05之外的批次（方案二）这2种方案得到的MoM值,重新评估孕妇胎儿发生唐氏综合征的风险。结果：采用方案一和方案二2种校正方案分别能把mMoM在0.90~1.10和0.95~1.05的百分比由校正前的64%和90%,提升到校正后的67%、99%和85%、99%。13 024例孕妇的唐氏综合征检出率和阳性率在原始方案和2种校正方案中差异不大。结论：对于孕中期血清三联唐氏综合征产前筛查,临床实验室可考虑在当前质控方案基础上增加自动化校正方案。
Objective: To explore an automated prenatal Down syndrome screening adjustment protocol for the second trimester triple marker screening to create a better method for prenatal screening with quality assurance. Methods: The multiple of median (MoM) of 13 024 second trimester maternal serum screening samples were adjusted using cumulative sum (CUSUM) adjustment protocol with adjustment targeting median of MoM (mMoM) outside 0.90-1.10 per batch or outside 0.95-1.05 per batch. The Down syndrome risk is recalculated according to the adjusted MoM. Result: Two adjustment protocols improved the percentage of median MoM within 0.90-1.10 and 0.95-1.05 from(64%, 90% to 67%, 99% and 85%, 99%). The differences of detection rate and false positive rate for Down syndrome between the original results and two adjustment protocols were mild. Conclusions: Clinical laboratory should consider the improving of current prenatal screening protocol with our automated CUSUM adjustment protocol.
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