新型冠状病毒抗原检测试剂关键原材料对产品质量的影响因素分析

Analysis of Factors Influencing the Quality of Key Raw Materials of Novel Coronavirus Antigen Detection Reagents

目的:为新型冠状病毒抗原检测试剂生产企业控制关键原材料质量、保证产品质量提供技术参考。方法:依据我省新型冠状病毒抗原产品在上市申请以及上市后使用发现的问题,调研相关生产企业,分析关键原材料对产品质量的影响。结果:已包被活性材料的硝酸纤维素膜、标记物垫以及卡壳等关键原材料影响产品质量,可能致使检测结果出现假阳性、假阴性和自测过程中质控线(C线)不显色等问题。结论:生产企业在产品设计开发及开展相关研究过程中,应认真研读国家的相关指导原则,从实际使用角度关注产品主要原材料对于产品质量的影响,从细节入手,持续生产出合格的产品。

Objective:To provide technical reference for novel coronavirus antigen detection reagent manufacturers to control the quality of key raw materials and ensure product quality.Methods:According to the problems found in the initial key processes of novel coronavirus antigen products in our province,field researches targeted related manufacturers and focuses were on the analysis of key raw materials as the factors that might affect the product quality.Results:Key raw materials such as nitrocellulose membrane,marker pad and shell that had been coated with active materials affected product quality,which might lead to false positive or negative results and no color development of quality control line(C line)during the self-test process.Conclusion:In the process of product design and development and relevant research,the manufacturer should carefully study the relevant national guidelines,pay more attention to the impact of the main raw materials on product quality and lay stress on details,so as to continue their qualified production.