2018—2022年西北地区精液分析外部质控结果评估  

Evaluation of external quality control for semen analysis in northwest of China from 2018 to 2022

作　　者：杨杰 刘茹月 王琪 马琳枝 周梁 张洲 YANG Jie;LIU Ru-yue;WANG Qi;MA Lin-zhi;ZHOU Liang;ZHANG Zhou(Center of Reproductive Medicine,Northwest Women’s&Children’s Hospital,Xi’an710000)

机构地区：[1]西北妇女儿童医院生殖中心,西安710000

出　　处：《生殖医学杂志》2023年第7期969-976,共8页Journal of Reproductive Medicine

基　　金：陕西省科技厅项目(2021SF-210)。

摘　　要：目的分析和评估2018—2022年西北地区精液分析的外部质控,为国内推广精液分析的外部质控积累经验。方法每年分别制作2个水平的精子浓度、精子活力和精子形态学分析的质控品,发放给各参评实验室进行外部质控。各参评实验室收到质控品后在规定时间内进行检测并及时反馈结果。结果参评实验室数量由2018年的12家增加至2022年的30家,使用计算机辅助精液分析系统(CASA)进行精液分析及质控的单位从5家增至21家。精子活力分析的平均变异系数(CV)在20%左右;浓度分析的CV从2018年的49.87%降至2022年的23.93%,降幅超过50%;精子形态学分析的CV是3个质控项目中最高的,但整体也呈下降趋势。Youden图显示,超过80%的参评实验室的检测结果都在95%可信区间内,失控原因中83.33%为随机误差,16.67%为系统误差,说明随机误差仍是参评单位失控的主要原因。结论通过操作培训和外部质评,各实验室间的CV逐渐缩小,但各参评实验室之间的结果差异较大,尤其是精子形态学分析。后续还需要进一步加强技术人员的标准化操作与质控培训,提高区域内精液分析的准确性和一致性。Objective:To evaluate and analyze the external quality control(EQC)for semen analysis in northwest China from 2018 to 2022,and accumulate experience for promoting domestic EQC of semen analysis.Methods:Quality control samples for sperm concentration,sperm motility and sperm morphology analysis at two levels were produced each year and distributed to each participating laboratory for external quality control.Each participating laboratory conducted testing within the specified time after receiving the quality control products and provided timely feedback on the results.Results:The number of laboratories participating in EQC increased from 12 to 30 during 2018-2022.In the meantime,the number of laboratories using computer-aided sperm analysis(CASA)increased from 5 to 21.The coefficient of variation(CV)for motility assessment was about 20%.The CV of concentration analysis decreased from 49.87% in 2018 to 23.93% in 2022,a decrease of over 50%.The CV for morphology assessment was the highest among the three items also showed a downtrend.The Youden chart showed that over 80% of the testing results of the participating laboratories were within the 95% confidence interval.Among the reasons for loss of control,random error was the main causes of out-of-control accounting for 83.33%,and systematic error for the rest 16.67%,indicating that random errors were still the main cause of loss of control for the participating units.Conclusions:Through operational training and external quality evaluation,the CV between laboratories gradually decreased,but the results varied significantly among participating laboratories,especially in sperm morphology analysis.In the future,it is necessary to further strengthen the standardized operation and quality control training of technical personnel to improve the accuracy and consistency of semen analysis within the region.

关 键 词：精液分析 外部质控 变异系数 Youden图 

分 类 号：R446.19[医药卫生—诊断学]