中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2014年
11期
870-875
,共6页
沈凤贤%赵丽%吕时铭%沈宇欢
瀋鳳賢%趙麗%呂時銘%瀋宇歡
침봉현%조려%려시명%침우환
唐氏综合征%产前诊断%妊娠中期%质量控制
唐氏綜閤徵%產前診斷%妊娠中期%質量控製
당씨종합정%산전진단%임신중기%질량공제
Down syndrome%Prenatal diagnosis%Pregnancy trimester,second%Quality control
目的：分析中孕期母血清学筛查质量管理的特点，探讨质量管理方法，提高质量管理水平。方法收集2011至2012年浙江省17家产前筛查机构筛查孕妇的临床资料及产前筛查数据进行统计分析，从孕妇年龄、体重、孕周、标本采集影响、血清标志物中位数的选择、分析软件使用等方面研究对筛查质量的影响。结果本研究收集了2011年417347例及2012年463846例唐氏综合征产前筛查数据。全省产前筛查孕妇年龄基本呈正态分布，不同筛查机构年龄分布不一致；全省及各筛查机构体重分布趋势相似；筛查孕周集中在17周左右，孕周确定方式各筛查机构存在显著差异。筛查机构本部采血标本和采血点送检标本所测的AFP及free β-hCG值可不同，采血点送检标本free β-hCG正偏倚尤为明显。加强对各采血点标本运输环节温度和时间控制后，两组标本的结果趋于一致。对标志物median MoM出现正、负偏倚的机构，采用本地人群的参比中位数后，筛查标志物Median MoM值更接近于1，筛查阳性率下降，但不影响检出率。本研究对随访到的213例阳性病例进行分析，用Lifecycle软件代替2T软件后多检出6例阳性病例，可提高检出率。结论在评价与比较不同实验室筛查质量时应考虑孕妇年龄、体重、孕周、标本采集等因素对评价指标筛查阳性率的影响。风险评估时的血清标志物中位数宜采用本地人群的数据；筛查分析软件的优化可减少筛查假阴性的发生。
目的：分析中孕期母血清學篩查質量管理的特點，探討質量管理方法，提高質量管理水平。方法收集2011至2012年浙江省17傢產前篩查機構篩查孕婦的臨床資料及產前篩查數據進行統計分析，從孕婦年齡、體重、孕週、標本採集影響、血清標誌物中位數的選擇、分析軟件使用等方麵研究對篩查質量的影響。結果本研究收集瞭2011年417347例及2012年463846例唐氏綜閤徵產前篩查數據。全省產前篩查孕婦年齡基本呈正態分佈，不同篩查機構年齡分佈不一緻；全省及各篩查機構體重分佈趨勢相似；篩查孕週集中在17週左右，孕週確定方式各篩查機構存在顯著差異。篩查機構本部採血標本和採血點送檢標本所測的AFP及free β-hCG值可不同，採血點送檢標本free β-hCG正偏倚尤為明顯。加彊對各採血點標本運輸環節溫度和時間控製後，兩組標本的結果趨于一緻。對標誌物median MoM齣現正、負偏倚的機構，採用本地人群的參比中位數後，篩查標誌物Median MoM值更接近于1，篩查暘性率下降，但不影響檢齣率。本研究對隨訪到的213例暘性病例進行分析，用Lifecycle軟件代替2T軟件後多檢齣6例暘性病例，可提高檢齣率。結論在評價與比較不同實驗室篩查質量時應攷慮孕婦年齡、體重、孕週、標本採集等因素對評價指標篩查暘性率的影響。風險評估時的血清標誌物中位數宜採用本地人群的數據；篩查分析軟件的優化可減少篩查假陰性的髮生。
목적：분석중잉기모혈청학사사질량관리적특점，탐토질량관리방법，제고질량관리수평。방법수집2011지2012년절강성17가산전사사궤구사사잉부적림상자료급산전사사수거진행통계분석，종잉부년령、체중、잉주、표본채집영향、혈청표지물중위수적선택、분석연건사용등방면연구대사사질량적영향。결과본연구수집료2011년417347례급2012년463846례당씨종합정산전사사수거。전성산전사사잉부년령기본정정태분포，불동사사궤구년령분포불일치；전성급각사사궤구체중분포추세상사；사사잉주집중재17주좌우，잉주학정방식각사사궤구존재현저차이。사사궤구본부채혈표본화채혈점송검표본소측적AFP급free β-hCG치가불동，채혈점송검표본free β-hCG정편의우위명현。가강대각채혈점표본운수배절온도화시간공제후，량조표본적결과추우일치。대표지물median MoM출현정、부편의적궤구，채용본지인군적삼비중위수후，사사표지물Median MoM치경접근우1，사사양성솔하강，단불영향검출솔。본연구대수방도적213례양성병례진행분석，용Lifecycle연건대체2T연건후다검출6례양성병례，가제고검출솔。결론재평개여비교불동실험실사사질량시응고필잉부년령、체중、잉주、표본채집등인소대평개지표사사양성솔적영향。풍험평고시적혈청표지물중위수의채용본지인군적수거；사사분석연건적우화가감소사사가음성적발생。
Objective To analyze the features of quality management of maternal serum prenatal screening for Down syndrome in the second trimester and investigate the methods to establish and improve quality control system.Methods Prenatal screening and clinical data were collected for statistical analysis from 17 prenatal screening centers in Zhejiang Province from 2011 to 2012.The impacts of maternal age , weight, gestational age , specimen collection , the median values of serum markers selection and different analysis software on prenatal screening results for Down syndrome were analyzed respectively .Results Totally 417 347 and 463 846 prenatal screening cases were collected in 2011 and 2012 respectively.The maternal age of the entire province presented as a Gaussian distribution.The age distributions of different screening institutions were inconsistent , while maternal weight distributions were similar.The approach to determine gestational age was significantly different among screening institutions.Median MoM of the samples from the blood collection points was different from those of the main screening center.Median MoM-freeβ-hCG was positive bias , particularly the specimens from the blood collection points.After strengthening the control of temperature and time during samples transportation , Median MoM-free β-hCG of specimens from blood collection points became nearly equal to those of main screening center .Use of local median made the median MoM value closer to 1.0 in the centers with positive or negtive bias of the markers , which had little effect in detection rate and decreased the false positive rate and screening positive rate.Six more positive cases were detected by the Lifecycle software instead of 2T software in 213 followed-up positive cases, which means the Lifecycle software can improve the detection rate.Conclusions The impact of maternal age, weight, gestational age, specimen collection and other factors on screening performance should be taken into consideration when it evaluates the screening quality of different laboratory .The use of local medians is necessary in prenatal screening.Optimization of screening analysis software can reduce false negative rate.
