CAJ | 학술논문

目的调查我国产前筛查实验室妊娠中期血清学标记物中位数的现状,探讨质量控制的方法及重要性. 方法 2013年,参加卫生部临床检验中心妊娠中期母血清学产前筛查室间质量评价的实验室中,442个实验室回报了甲胎蛋白(α-fetal protein,AFP)、人绒毛膜促性腺激素(human chorionic gonadotropin,hCG)、β-hCG、游离β-hCG、游离雌三醇(unconjugated estriol,uE3)中位数的相关信息.根据实验室所采用检测系统的厂商分组,使用美国PE、美国Beckman、广州丰华、瑞士罗氏、广州达瑞、德国西门子和美国雅培检测系统的实验室分别为170、1 20、31、26、13、11和9个.分析各实验室确定血清学标记物中位数的方式.根据各实验室上报的妊娠14～20周每周第3天的中位数,统计存在离群值的实验室个数.采用单个样本t检验,比较本研究结果与已发表文献的中国孕妇多中心研究结果. 结果 19.0％(84/442)的实验室自己确定妊娠中期母血清学产前筛查标记物的中位数;4.3％(19/442)与检测系统厂商共同确定中位数;76.7％(339/442)直接采用检测系统内嵌的中位数,其中97.9％ (332/339)未对使用的中位数进行验证,84.3％(280/332)不知如何验证.各检测系统妊娠14～20周的AFP和uE3中位数随孕周升高,hCG、β-hCG和游离β-hCG中位数随孕周降低.美国PE系统的AFP、游离β-hCG和uE3的离群值均较多[分别为4.8％(5 0/1 050)、6.8％(70/1029)和11.8％(85/721)],且各孕周均有分布.广州丰华系统的AFP、广州达瑞系统的游离β-hCG、德国西门子系统的uE3离群值比例较高[分别为9.5％(20/210)、13.2％(12/91)和23.4％(18/77)].本研究结果与多中心研究采用美国PE检测系统对我国汉族孕妇妊娠中期母血清学AFP和游离β-hCG中位数比较,妊娠14周和18周AFP中位数2组数据比较差异无统计学意义(P值均＞ 0.05),多中心研究妊娠15、16、1 7、19、20周的AFP中位数均高于本研究(t值分别为-7.257、-3.204、-5.479、-3.253和-20.089,P值均＜ 0.05).多中心研究妊娠14～20周的游离β-hCG中位数均高于本研究(t值分别为-80.749、-199.779、-142.601、-90.732、-72.984、-47.935和-39.409,P值均＜0.01). 结论我国大部分产前筛查实验室未对妊娠中期母血清学产前筛查标记物中位数进行验证,同一检测系统内的中位数存在差异. 目的調查我國產前篩查實驗室妊娠中期血清學標記物中位數的現狀,探討質量控製的方法及重要性. 方法 2013年,參加衛生部臨床檢驗中心妊娠中期母血清學產前篩查室間質量評價的實驗室中,442箇實驗室迴報瞭甲胎蛋白(α-fetal protein,AFP)、人絨毛膜促性腺激素(human chorionic gonadotropin,hCG)、β-hCG、遊離β-hCG、遊離雌三醇(unconjugated estriol,uE3)中位數的相關信息.根據實驗室所採用檢測繫統的廠商分組,使用美國PE、美國Beckman、廣州豐華、瑞士囉氏、廣州達瑞、德國西門子和美國雅培檢測繫統的實驗室分彆為170、1 20、31、26、13、11和9箇.分析各實驗室確定血清學標記物中位數的方式.根據各實驗室上報的妊娠14～20週每週第3天的中位數,統計存在離群值的實驗室箇數.採用單箇樣本t檢驗,比較本研究結果與已髮錶文獻的中國孕婦多中心研究結果. 結果 19.0％(84/442)的實驗室自己確定妊娠中期母血清學產前篩查標記物的中位數;4.3％(19/442)與檢測繫統廠商共同確定中位數;76.7％(339/442)直接採用檢測繫統內嵌的中位數,其中97.9％ (332/339)未對使用的中位數進行驗證,84.3％(280/332)不知如何驗證.各檢測繫統妊娠14～20週的AFP和uE3中位數隨孕週升高,hCG、β-hCG和遊離β-hCG中位數隨孕週降低.美國PE繫統的AFP、遊離β-hCG和uE3的離群值均較多[分彆為4.8％(5 0/1 050)、6.8％(70/1029)和11.8％(85/721)],且各孕週均有分佈.廣州豐華繫統的AFP、廣州達瑞繫統的遊離β-hCG、德國西門子繫統的uE3離群值比例較高[分彆為9.5％(20/210)、13.2％(12/91)和23.4％(18/77)].本研究結果與多中心研究採用美國PE檢測繫統對我國漢族孕婦妊娠中期母血清學AFP和遊離β-hCG中位數比較,妊娠14週和18週AFP中位數2組數據比較差異無統計學意義(P值均＞ 0.05),多中心研究妊娠15、16、1 7、19、20週的AFP中位數均高于本研究(t值分彆為-7.257、-3.204、-5.479、-3.253和-20.089,P值均＜ 0.05).多中心研究妊娠14～20週的遊離β-hCG中位數均高于本研究(t值分彆為-80.749、-199.779、-142.601、-90.732、-72.984、-47.935和-39.409,P值均＜0.01). 結論我國大部分產前篩查實驗室未對妊娠中期母血清學產前篩查標記物中位數進行驗證,同一檢測繫統內的中位數存在差異.
목적 조사아국산전사사실험실임신중기혈청학표기물중위수적현상,탐토질량공제적방법급중요성. 방법 2013년,삼가위생부림상검험중심임신중기모혈청학산전사사실간질량평개적실험실중,442개실험실회보료갑태단백(α-fetal protein,AFP)、인융모막촉성선격소(human chorionic gonadotropin,hCG)、β-hCG、유리β-hCG、유리자삼순(unconjugated estriol,uE3)중위수적상관신식.근거실험실소채용검측계통적엄상분조,사용미국PE、미국Beckman、엄주봉화、서사라씨、엄주체서、덕국서문자화미국아배검측계통적실험실분별위170、1 20、31、26、13、11화9개.분석각실험실학정혈청학표기물중위수적방식.근거각실험실상보적임신14～20주매주제3천적중위수,통계존재리군치적실험실개수.채용단개양본t검험,비교본연구결과여이발표문헌적중국잉부다중심연구결과. 결과 19.0％(84/442)적실험실자기학정임신중기모혈청학산전사사표기물적중위수;4.3％(19/442)여검측계통엄상공동학정중위수;76.7％(339/442)직접채용검측계통내감적중위수,기중97.9％ (332/339)미대사용적중위수진행험증,84.3％(280/332)불지여하험증.각검측계통임신14～20주적AFP화uE3중위수수잉주승고,hCG、β-hCG화유리β-hCG중위수수잉주강저.미국PE계통적AFP、유리β-hCG화uE3적리군치균교다[분별위4.8％(5 0/1 050)、6.8％(70/1029)화11.8％(85/721)],차각잉주균유분포.엄주봉화계통적AFP、엄주체서계통적유리β-hCG、덕국서문자계통적uE3리군치비례교고[분별위9.5％(20/210)、13.2％(12/91)화23.4％(18/77)].본연구결과여다중심연구채용미국PE검측계통대아국한족잉부임신중기모혈청학AFP화유리β-hCG중위수비교,임신14주화18주AFP중위수2조수거비교차이무통계학의의(P치균＞ 0.05),다중심연구임신15、16、1 7、19、20주적AFP중위수균고우본연구(t치분별위-7.257、-3.204、-5.479、-3.253화-20.089,P치균＜ 0.05).다중심연구임신14～20주적유리β-hCG중위수균고우본연구(t치분별위-80.749、-199.779、-142.601、-90.732、-72.984、-47.935화-39.409,P치균＜0.01). 결론 아국대부분산전사사실험실미대임신중기모혈청학산전사사표기물중위수진행험증,동일검측계통내적중위수존재차이.
Objective To investigate the current situation in application of median levels in second trimester in prenatal screening laboratory throughout China and to understand the methods and importance of quality control.Methods Of those laboratories that participated in the national external quality assessment (EQA) for second trimester maternal serum screening in 2013, 442 submitted the medians for α-fetal protein (AFP), human chorionic gonadotropin (hCG), β-hCG, free β-hCG and unconjugated estriol (uE3) and related information.We categorized the medians according to the platform.There were 170, 210, 31, 26, 13, 11 and nine laboratories using the detection systems from Perkin Elmer, Beckman Coulter, Fenghua, Roche, Darui, Siemens and Abbott, respectively.The method of setting up the medians for each laboratory was analyzed.The number of laboratories, which was the outliers, was determined according to the reported medians on the third day of each week from 14th to 20th gestational weeks.Single sample t-test was applied to compare the result of this study with published results from a multi-center study of pregnant women in China.Results Among all laboratories, 19.0％ (84/442) of the recruited laboratories setup the median on their own.And 4.3％ (19/442) did this with their vendors;76.7％ (339/442) used the default median from the software, among them 97.9％ (332/339) did not verify their medians and 84.3％ (280/332) had no idea of how to do.Medians of AFP and uE3 increased with gestational age, while medians of hCG, β-hCG and free β-hCG decreased in all detection systems.More outliers were found for AFP, free β-hCG and uE3 medians in Perkin Elmer system, which scattered in each gestational age.A higher proportion of AFP in Fenghua system, free β-hCG in Darui system and uE3 in Siemens system were reported [9.5％ (20/210), 13.2％ (12/91) and 23.4％ (18/77), respectively].The medians of AFP and β-hCG using Perkin Elmer platform were compared between this study and the previous multi-center study in Chinese women.The results did not show significant difference in AFP median at 14th and 18th week of gestation (both P ＞ 0.05), while higher medians in AFP at 15th, 16th, 17th, 19th and 20th week of gestation (t=-7.257,-3.204,-5.479,-3.253 and-20.089, respectively, all P ＜ 0.05) and higher β-hCG median at 14th to 20th week of gestation (t=-80.749,-199.779,-142.601, -90.732,-72.984,-47.935 and-39.409, respectively, all P ＜ 0.01) were found in the previous study.Conclusion Most laboratories in our country never verify their medians for second trimester screening program and the medians vary among different settings.