摘要
目的按照国家体外诊断试剂抽验工作方案,从6家企业共抽检18批次试剂盒,评价地中海贫血基因突变检测试剂盒的质量。方法依据企业各自的注册产品标准或产品技术要求,使用企业参考品或国家参考品对准确性、特异性、检测限和重复性4个项目进行检验,同时依据YY/T 1527-2017《α/β-地中海贫血基因分型检测试剂盒》行业标准,使用统一的地中海贫血核酸检测国家参考品,对准确性、特异性和检测限3个项目进行探索研究。结果 18批次试剂均符合各自注册产品标准或产品技术要求,但与行业标准的要求比较,部分企业产品标准或产品技术要求存在缺项的现象。依据推荐性的行业标准,使用统一的国家参考品进行检测,有1批次试剂的检测限不符合行业标准的要求,其它批次试剂的结果均符合要求。结论企业应根据发布的行业标准要求,及时补充完善自己的产品技术要求,并建议统一使用国家参考品进行检测,使试剂盒的质量评价具有可比性。
Objective According to the National In vitro Diagnostic(IVD)Reagent Sampling Work Program,a total of 18 batches of kits were sampled from 6 companies to evaluate the quality of thalassemia gene mutation detection kits. Methods The accuracy,specificity,limit of detection and repeatability were verified in accordance with the product technical requirements by using the enterprise reference or national reference. Exploratory study for the accuracy,specificity,limit of detection was also conducted by using the national reference and referring to the industry standard ofα/β-thalassemia gene typing detection kit. Results All 18 batches of testing reagents meet the product technical requirements,but the technical requirements of some enterprises have the phenomenon of missing item compared with the requirements of the industry standards. Based on the recommended industry standard,the unified national reference was used for testing. The detection limit of 1 batch of reagents does not meet the requirements of industry standards,and the results of other batches of reagents meet the requirements. Conclusion Enterprises should timely complete and improve their own product technical requirements according to the published industry standard requirements and recommend the uniform use of national reference products for testing to make the quality evaluation of the kits comparable.
作者
张文新
于婷
孙楠
高飞
黄杰
曲守方
ZHANG Wenxin;YU Ting;SUN Nan;GAO Fei;HUANG Jie;QU Shoufang(Division of In Vitro Diagnostic for Non Infectious Diseases,Institute for In Vitro Diagnostics Control,National Institutes for Food and Drug Control,Beijing,China,100050)
出处
《分子诊断与治疗杂志》
2020年第3期279-282,304,共5页
Journal of Molecular Diagnostics and Therapy
基金
生殖健康及重大出生缺陷防控研究(2016YFC1000300)。
作者简介
并列第一作者:张文新;并列第一作者:于婷;通信作者:黄杰,E mail:jhuang5522@126.com;通信作者:曲守方,E mail:qushoufang@126.com。
