2021-2022年江苏省母血清学产前筛查室内质控数据的室间比对结果分析  

Analysis of inter room comparison results of internal quality control data for maternal serological prenatal screening in Jiangsu Province from 2021 to 2022

作　　者：张颖[1] 段红蕾[1] 李洁[1] 贾支俊[2] Zhang Ying;Duan Honglei;Li Jie;Jia Zhijun(Prenatal Diagnosis Center,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;Department of Nuclear Medicine,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院产前诊断中心,南京210008 [2]南京大学医学院附属鼓楼医院核医学科,南京210008

出　　处：《中华预防医学杂志》2024年第3期358-363,共6页Chinese Journal of Preventive Medicine

基　　金：南京大学中国医院改革发展研究院课题项目(NDYG2022045);南京鼓楼医院医学发展医疗救助基金会资助项目(NDYG2022045)。

摘　　要：本研究分析2021-2022年江苏省开展母血清学产前筛查的实验室上报的相关数据,通过各实验室室内质控数据的比对,进行江苏省内产前血清学筛查的质量评价。采用江苏省产前筛查质控分析平台收集2021-2022年江苏省参加产前筛查质控的各实验室早孕期和中孕期母血清学筛查质控的测定方法、3个浓度的质控数据结果、仪器平台和试剂等相关信息。首先对各实验室检测结果进行统计分析,通过室内质控的变异系数对各实验室的精密度进行评价;其次对使用不同实验平台的实验室进行室间比对,评价其一致性。结果显示,2021年和2022年妊娠相关蛋白-A(PAPP-A)检测变异系数满足行业要求的实验室比例分别为87.5%(7/8)和92.3%(12/13);2021年和2022年游离人绒毛膜促性腺激素(Free β-hCG)(早孕)检测变异系数满足行业要求的实验室比例为97.5%(39/40)和95.5%(42/44),2021年和2022年甲胎蛋白(AFP)检测变异系数满足行业要求的实验室比例分别为100%(40/40)和90.9%(40/44),2021年和2022年游离 β-hCG(中孕)检测变异系数满足行业要求的实验室比例分别为100%(40/40)和95.5%(42/44);各指标的室间比对一致性为100%。综上,江苏省母血清学产前筛查具有较高一致性,对于少部分稳定性较差的实验室需根据数据分析结果做出周期性的评估及整改,完善母血清学产前筛查质量控制管理。The relevant data reported by laboratories carrying out serological prenatal screening in Jiangsu Province from 2021 to 2022 were retrospectively analyzed,and the provincial inter-ventricular quality assessment was realized by comparing the internal quality control data of laboratories.The quality control analysis platform of prenatal screening in Jiangsu Province was used to collect the determination methods,quality control data results of three concentrations,instrument platform,reagents and other relevant information of maternal serological screening quality control in early and middle pregnancy in each laboratory from 2021 to 2022.Firstly,the test results of each laboratory were statistically analyzed,and the precision of each laboratory was evaluated by the variation coefficient of indoor quality control.Secondly,the consistency was evaluated by comparing laboratories with different experimental platforms.The results showed that the passing rate of PAPP-A(pregnancy-associated plasma protein-A)precision test in 2021 and 2022 was 87.5%(7/8)and 92.3%(12/13),respectively.The accuracy pass rate of the Freeβ-hCG(free beta-human chorionic gonadotrophin)(early pregnancy)test in 2021 and 2022 was 97.5%(39/40)and 95.5%(42/44),and the accuracy pass rate of the AFP(alpha-fetal protein)test in 2021 and 2022 was 100%(40/40)and 90.9%(40/44),respectively.The accuracy pass rate of Freeβ-hCG(middle pregnancy)test in 2021 and 2022 was 100%(40/40)and 95.5%(42/44),respectively.The consistency of each index was 100%.In conclusion,the relevant data reported by laboratories carrying out serological prenatal screening in Jiangsu Province has a high consistency,and for a small number of laboratories with poor stability,it is necessary to make periodic evaluation and rectification according to the data analysis results,so as to improve the quality control management of maternal serological prenatal screening.

关 键 词：血清学筛查 质量控制 室间比对分析 

分 类 号：R714[医药卫生—妇产科学]