新型冠状病毒(2019-nCoV)抗原检测试剂(胶体金法)的生产工艺特点及风险防控要点

      Features of Production Process and Risk Prevention and Control Points of Corona Virus Disease 2019 (2019-nCoV) Antigen Detection Reagent (Colloidal Gold Method)

      • 摘要: 目前新型冠状病毒(2019-nCoV)抗原检测试剂(胶体金法)已应用到基层医疗卫生机构就诊,伴有呼吸道、发热等症状且出现症状5天以内的人员;隔离观察人员;有抗原自我检测需求的社区居民。该试剂的广泛应用可有效缩短检测时间,降低检测成本和时间成本,缓解核酸检测压力。文章详述了该新冠抗原检测试剂的结构组成、测试原理、生产工艺以及关键风险点,旨在对生产企业的相关工作规范的制定,组织安全生产和监管部门的核查监督提供参考。

         

        Abstract: Corona Virus Disease 2019 (2019-nCoV) antigen detection reagent (colloidal gold method) has been applied to people who go to basic medical and health institutions for medical treatment and have respiratory tract, fever and other symptoms within 5 days, isolate observers, community residents who need antigen self-testing. The wide application of the reagent can effectively shorten the detection time, reduce the detection cost and time cost, and alleviate the pressure of nucleic acid detection. The article details the structural components, testing principles, production process and key risk points of the new coronavirus antigen test reagents, with the aim of providing a reference for the development of relevant work specifications for manufacturers, the organization of safe production and the verification and supervision of regulatory authorities.

         

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