胶体金免疫层析定性检测试剂的质量控制与评价  

Quality Control and Evaluation of Colloidal Gold Immunochromatography Qualitative Detection Reagents

作　　者：李颖 李丽莉[1] Li Ying;Li Lili(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2024年第1期53-57,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨胶体金免疫层析定性检测试剂质量控制技术关键要求,为生产企业、检验机构质量控制及评价提供参考,有效地促进该类体外诊断试剂质量水平的提高。方法:结合胶体金免疫层析定性检测试剂质量标准要求及分类管理,对该类试剂质量的关键性能要素进行剖析,提出相应建议,提高试剂质量。结果与结论:质量控制与评价是贯穿产品全流程的核心要素,膜条宽度、液体移行速度、阴性符合率、阳性符合率、检出限、重复性是胶体金免疫层析定性检测试剂质量控制及评价的关键性能指标,对于试剂的质量至关重要。相关生产研发企业要合理设计性能要求,完善质量管理体系;检验机构要根据产品性能要点做好质量评价;监管部门要根据行业需要和监管需要,加快标准制修订工作,加强上市后监管;从生产、检验及监管各环节对这些关键性能指标进行控制,提高试剂的质量标准,从而满足临床和监管的需求。Objective:To discuss the key requirements of quality control technology for colloidal gold immunochromatography qualitative detection reagents,aiming to provide reference for quality control and evaluation of production enterprises and inspection institutions,and eff ectively promote the quality level of such in vitro diagnostic reagents.Method:Based on the quality standard requirements and classifi cation management of colloidal gold immunochromatography qualitative detection reagents,analyze the key performance elements of this type of reagent quality,put forward corresponding suggestions,improve reagent quality.Results and Conclusion:Quality control and evaluation are the core elements that run through the entire product process.Membrane width,liquid migration speed,negative compliance rate,positive compliance rate,detection limit and repeatability are the key performance indicators for quality control and evaluation of colloidal gold immunochromatography qualitative detection reagents,which are crucial for the quality of reagents.Relevant production and R&D enterprises should reasonably design performance requirements and improve quality management systems,inspection agencies should conduct quality evaluations based on the key product performance points,regulatory authorities should accelerate the revision of standards and strengthen post listing supervision based on industry and regulatory needs.Control these key performance indicators from various aspects of production,inspection,and supervision to improve the quality standards of reagents,so as to meet the clinical and regulatory needs.

关 键 词：胶体金免疫层析 质量控制 体外诊断试剂 

分 类 号：R97[医药卫生—药品]