摘要
目的分析2017年至2019年连续3年不同实验室Y染色体长臂无精子因子(Yq azoospermia factor,YqAZF)微缺失检测的室间质量评价(YqAZF microdeletion external quality assessment,YEQA)结果,以期为改进和规范YqAZF微缺失检测质量管理体系提供指导意见。方法总结2017年至2019年期间由中国医师协会男科医师分会组织开展YEQA质控,每年向参与单位发放3个全血抽提的DNA质控品,包括无YqAZF微缺失、YqAZFb+c微缺失、YqAZFc微缺失等不同类型样本。各单位按规定要求上报检测方法、仪器和试剂、检测结果和结果解释等信息。专家对反馈结果进行评判及分析,得出分数和整体描述性评价。结果2017年至2019年YEQA参与单位数逐年递增,3年累计报名172家,有效结果回收148家,回收率86.0%(148/172)。3年回收率分别为90.2%、92.6%、79.2%。参与单位来自9类不同实验室,以检验科/中心实验室、生殖/遗传中心为主;检测方法上,91.9%(136/148)为实时荧光PCR法检测;检测结果总分存在波动性,其中基因型检测平均得分率逐年递增(2017年至2019年分别为88.3%、93.0%、94.7%),而对检测结果的临床解释最为薄弱。2018年总平均分最高,为86.8分。结论中国YEQA连续3年调查结果整体情况令人满意。但仍存在个别单位基因型检测错误、报告格式不规范、临床解释不全面等问题。检测单位应加强质量控制意识,及时采取措施纠正检测过程中出现的偏差和错误,积极参与YEQA计划,以提高YqAZF微缺失检测整体水平。
Objective To analyze the external quality assessment results of Yq azoospermia factor(YqAZF)microdeletion(YEQA)in China from 2017 to 2019 in order to improve and standardize the quality assessment system of YqAZF microdeletion detection.Methods The nationwide YEQA was organized by the Andrology Committee of Chinese Medical Doctor Association.In each year during 2017 to 2019,three DNA quality control samples extracted from whole blood,including different types of YqAZF microdeletion samples,such as no YqAZF microdeletion,losses of YqAZFb+c or YqAZFc,were distributed to the participating institutions.All institutions reported the testing methods,instruments and reagents,testing results and other information in the prescribed format.Experts from China Alliance Committee of YqAZF screening evaluated and analyzed the feedback results,and obtained the score and overall descriptive evaluation.Results The number of YEQA participating units increased year by year from 2017 to 2019,with a total of 172 units enrolled in the 3 years and 148 valid results recovered,with a recovery rate of 86.0%(148/172).The 3-year recovery rates were 90.2%,92.6%,and 79.2%,respectively.The participating departments were from 9 different departments,mainly from the artificial reproductive/genetic center and clinical/central laboratory.In terms of methodology,real-time PCR detection was the majority[91.9%(136/148)].The total score fluctuated,with the highest overall average score in 2018.The average score of genotype detection increased year by year(88.3%,93.0%,94.7%,respectively),while the clinical interpretation of the testing results was the weakest part.The highest overall mean score was 86.8 in 2018.Conclusion In general,the improvements of 3-year YEQA in China is satisfactory.However,there are still some problems,such as irregular report format,incomplete clinical interpretation and even wrong genotype result.Testing institutions should be strengthened the awareness of quality control,taken timely measures to correct the deviations and err
出处
《中华生殖与避孕杂志》
CAS
CSCD
北大核心
2022年第8期837-844,共8页
Chinese Journal of Reproduction and Contraception
基金
上海申康医院发展中心临床三年行动计划(SHDC2020CR3077B)
宁夏回族自区重点研发计划项目(2020BFH02002)
国家重点研发计划(2017YFC1002003)
上海市科委“科技创新行动计划”港澳台科技合作项目(21410760300)。
