机构地区:[1]国家卫生健康委科学技术研究所,WHO人类生殖合作研究中心,国家卫生健康委男性生殖健康重点实验室,北京100081 [2]北京协和医学院研究生院,北京100730 [3]沈阳东方菁华医院,沈阳110005 [4]兰州大学第一医院生殖医学专科医院,兰州730000 [5]成都西囡妇科医院,成都610000 [6]吉林大学第一医院,长春130021
出 处:《生殖医学杂志》2019年第12期1494-1501,共8页Journal of Reproductive Medicine
基 金:中华医学会临床医学科研专项基金(16020510667);中国医学科学院医学与健康科技创新工程(2018-I2M-1-004)
摘 要:目的在全国四省一市,建立精液分析外部质量控制网络。方法2017年在辽宁省沈阳市、甘肃省兰州市、四川省成都市、吉林省长春市和北京市,开展精液分析外部质量控制网络建立方法的初步探索。主要参加实验室为各省市三甲医院的男科实验室、生殖中心实验室、精子库实验室和临床检验实验室,共106家单位。采用在指定实验室集中发放质控品,现场评估的形式。主要外部质量控制的方法采用《WHO人类精液检查和处理实验室手册(第5版)》精液分析标准化方法,包括改良Neubauer血细胞计数板评估精子浓度、活动力视频录像评估、精子活动力、伊红苯胺黑评估精子存活率、巴氏染色方法评估精子形态,分别用变异系数(CV)和Youden图评估外部质控的结果。结果精子存活率评估四省一市两个质控品的CV均在15%以下;而仅吉林省精子浓度和辽宁省精子活动力评估中两个质控品的CV在15%以下;精子形态学评估四省一市两个质控品的CV均在15%以上。Youden图分析精子浓度显示:23.53%、25.00%、36.84%、10.00%和18.18%的质控结果均在95%可信区间(95%CI)内;Youden图分析活动力显示:9.38%、25.00%、44.44%、12.50%和30.00%的质控结果均在95%CI内;Youden图分析精子存活率显示:8.33%、37.50%、47.37%、10.00%和20.00%的质控结果均在95%CI内。结论本研究证实外部质量控制网络的建立方法可行且结果可靠,其中精子存活率最容易质控,易于操作;精子浓度和活动力的外部质控方法还需进一步优化;而精子形态评估最难质控,使用桥连显微镜的方法便于质控。Objective:To establish external quality control network for semen analysis in four provinces and one city.Methods:The establishment method of external quality control network for semen analysis was preliminarily explored in Shenyang City,Liaoning Province,Lanzhou City,Gansu Province,Chengdu City,Sichuan Province,Changchun City,Jilin Province and Beijing in 2017.The main participating laboratories are the andrology laboratories,the reproductive center laboratories,the sperm bank laboratories and the clinical laboratories of the provincial and municipal third-level hospitals.The quality control products are distributed centrally in designated laboratories and assessed on site.The standardized methods for semen analysis of WHO Laboratory Manual for the Examination and Processing of Human Semen(5th edition)were used.The method of external quality control included using improved Neubauer haemocytometer chamber to assess sperm concentration,preparation of a video-recording to assess sperm motility,using eosin-nigrosin to assess sperm vitality,using Papanicolaou staining to evaluate sperm morphology.The results of external quality control were evaluated by coefficient of variation(CV)and Youden chart,respectively.Results:The CVs of sperm vitality of two quality control samples were below 15%in four provinces and one city.The CVs of sperm concentration of Jilin Province and CVs of sperm motility of Liaoning Province for two quality control samples were below 15%.All the CVs of sperm morphology assessment of two quality control samples were above 15%.The Youden chart analysis of sperm concentration showed that the quality control results of 23.53%,25.00%,36.84%,10.00%and 18.18%for the two quality control samples were within the 95%confidence interval(95%CI).The Youden chart analysis of sperm motility showed that the quality control results of 9.38%,25.00%,44.44%,12.50%and 30.00%for the two quality control samples were within the 95%CI confidence interval.The Youden chart analysis of sperm survival rate showed that the qua
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