基于患者标本的唐氏综合征产前筛查自动化校正方案探讨
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摘要
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.
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.
引文
[1]何法霖,王薇,钟堃,等.我国妊娠中期母血清学产前筛查标记物中位数的调查与分析[J].中华围产医学杂志,2015,18(10):761-765.
[2]边旭明,蒋宇林.重视唐氏综合征产前筛查质量控制和评价[J].实用妇产科杂志,2014,30(2):81-83.
[3]胡娅莉.再论产前筛查质量控制的重要性[J].中华围产医学杂志,2011,14(2):68-69.
[4]蒋宇林,刘俊涛,刘善英,等.唐氏综合征产前筛查指标中位数倍数值中位数监测和质量评价方法的应用分析[J].实用妇产科杂志,2014,30(2):103-107.
[5] Currier R, Wu N, Van Meter K, et al. Integrated and first trimester prenatal screening in California:program implementation and patient choice for follow-up services[J].Prenat Diagn,2012,32(11):1077-1083.
[6]何法霖,王薇,钟堃,等.全国妊娠早期母血清学筛查的室间质量评价和室内质量控制结果分析[J].中华围产医学杂志,2015,18(8):621-624.
[7] Palomaki GE, Lee JE, Canick JA, et al. Technical standards and guidelines:prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements[J]. Genet Med,2009,11(9):669-681.
[8] Wald NJ, Rodeck C, Hackshaw AK, et al. First and second trimester antenatal screening for Down's syndrome:the results of the Serum, Urine and Ultrasound Screening Study(SURUSS)[J]. J Med Screen,2003,10(2):56-104.
[9]陶炯,刘晓梅,周钢,等.基于生物统计学原则的唐氏综合征产前筛查质量控制和评价[J].中国计划生育和妇产科,2016,8(1):14-19.
[10]赵欣荣,陶炯,张海鸥,等.妊娠中期母血清学筛查胎儿唐氏综合征的效率——50086例分析[J].中华围产医学杂志,2014,17(9):638-641.
[11] Wald NJ, Rodeck C, Hackshaw AK, et al. First and second trimester antenatal screening for Down's syndrome:the results of the Serum, Urine and Ultrasound Screening Study(SURUSS)[J]. Health Technol Assess,2003,7(11):1-77.
[12]罗军,沈歈忱,唐振华.孕中期三联筛查唐氏综合征和18三体综合征的临床价值[J].诊断学理论与实践,2011,10(3):255-259.
[13]张彬,岳朝艳,应春妹.上海地区中孕期唐氏综合征血清学筛查的应用价值探讨[J].诊断学理论与实践,2017,16(2):213-216.
[14] Li B, Sahota DS, Lao TT, et al. Applicability of firsttrimester combined screening for fetal trisomy 21 in a resource-limited setting in mainland China[J]. BJOG,2016,123 Suppl 3:23-29.
[15] Nix B, Wright D, Baker A. The impact of bias in MoM values on patient risk and screening performance for Down syndrome[J]. Prenat Diagn,2007,27(9):840-845.
[2]边旭明,蒋宇林.重视唐氏综合征产前筛查质量控制和评价[J].实用妇产科杂志,2014,30(2):81-83.
[3]胡娅莉.再论产前筛查质量控制的重要性[J].中华围产医学杂志,2011,14(2):68-69.
[4]蒋宇林,刘俊涛,刘善英,等.唐氏综合征产前筛查指标中位数倍数值中位数监测和质量评价方法的应用分析[J].实用妇产科杂志,2014,30(2):103-107.
[5] Currier R, Wu N, Van Meter K, et al. Integrated and first trimester prenatal screening in California:program implementation and patient choice for follow-up services[J].Prenat Diagn,2012,32(11):1077-1083.
[6]何法霖,王薇,钟堃,等.全国妊娠早期母血清学筛查的室间质量评价和室内质量控制结果分析[J].中华围产医学杂志,2015,18(8):621-624.
[7] Palomaki GE, Lee JE, Canick JA, et al. Technical standards and guidelines:prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements[J]. Genet Med,2009,11(9):669-681.
[8] Wald NJ, Rodeck C, Hackshaw AK, et al. First and second trimester antenatal screening for Down's syndrome:the results of the Serum, Urine and Ultrasound Screening Study(SURUSS)[J]. J Med Screen,2003,10(2):56-104.
[9]陶炯,刘晓梅,周钢,等.基于生物统计学原则的唐氏综合征产前筛查质量控制和评价[J].中国计划生育和妇产科,2016,8(1):14-19.
[10]赵欣荣,陶炯,张海鸥,等.妊娠中期母血清学筛查胎儿唐氏综合征的效率——50086例分析[J].中华围产医学杂志,2014,17(9):638-641.
[11] Wald NJ, Rodeck C, Hackshaw AK, et al. First and second trimester antenatal screening for Down's syndrome:the results of the Serum, Urine and Ultrasound Screening Study(SURUSS)[J]. Health Technol Assess,2003,7(11):1-77.
[12]罗军,沈歈忱,唐振华.孕中期三联筛查唐氏综合征和18三体综合征的临床价值[J].诊断学理论与实践,2011,10(3):255-259.
[13]张彬,岳朝艳,应春妹.上海地区中孕期唐氏综合征血清学筛查的应用价值探讨[J].诊断学理论与实践,2017,16(2):213-216.
[14] Li B, Sahota DS, Lao TT, et al. Applicability of firsttrimester combined screening for fetal trisomy 21 in a resource-limited setting in mainland China[J]. BJOG,2016,123 Suppl 3:23-29.
[15] Nix B, Wright D, Baker A. The impact of bias in MoM values on patient risk and screening performance for Down syndrome[J]. Prenat Diagn,2007,27(9):840-845.