Y染色体微缺失检测试剂盒行业标准的建立  

Establishment of industry standards for Y chromosome microdeletion detection kits

作　　者：于婷[1] 黄杰[1] YU Ting;HUANG Jie(National Institutes for Food and Drug Control,Beijing,China,100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《分子诊断与治疗杂志》2024年第5期800-803,共4页Journal of Molecular Diagnostics and Therapy

基　　金：国家重点研发计划(2018YFC1002400)。

摘　　要：目的建立Y染色体微缺失检测试剂盒行业标准。方法选择9个厂家的Y染色体微缺失检测试剂盒,统一发放Y染色体微缺失检测参考品,按照拟定的行业标准,对外观、检测限、阳性参考品符合率、阴性参考品符合率和重复性项目进行验证。结果8个试剂盒的全部项目的检测结果均满足要求。检测限和阳性参考品符合率项目中,仅试剂盒8未检出AZFa微缺失,不满足要求。结论大部分验证结果均能满足拟定行标中的要求,表明行业标准各指标具有一定的合理性,可操作性强。Y染色体微缺失检测试剂盒行业标准的建立将有助于规范这类试剂盒发展,提升质量,并为监管提供技术支持。Objective To validate the industry standard for Y chromosome microdeletion detec⁃tion kit.Methods A detection kit for nine types of Y chromosome microdeletions was chosen.Reference ma⁃terials for Y chromosome microdeletion detection were distributed uniformly.The appearance,detection limit,compliance rate of positive/negative references,and repeatability were verified according to industry standards.Results The test results for all items in the 8 test kits meet the requirements.However,only kit 8 did not de⁃tect any AZFa microdeletions in the items for detection limit and positive reference rate,which means it did not meet the requirements.Conclusion Most of the validation results meet the requirements of the proposed industry standard,indicating that the indicators of the industry standard are reasonable and feasible.The estab⁃lishment of an industry standard for Y chromosome microdeletion detection kits will help regulate the develop⁃ment of such kits,improve quality,and provide technical support for regulation.

关 键 词：Y染色体微缺失 试剂盒 行业标准 

分 类 号：TH77[机械工程—仪器科学与技术]