便潜血检测试剂盒(胶体金法)技术要点探讨  

Discussion on the Specific Technical Points of FOB Diagnostic Kits(by Colloidal Gold Method)

作　　者：刘世红 陈雄 席仲兴[2] 

机构地区：[1]甘肃省医疗器械检验检测所,兰州730101 [2]兰州生物制品研究所有限责任公司,兰州730046

出　　处：《中国药事》2015年第11期1192-1196,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨便潜血检测试剂盒(胶体金法)生产、注册过程中的技术要点。方法:介绍试剂盒的反应原理、生产过程中使用的主要原、辅材料及相应质量控制要点。结果与结论:探讨影响试剂盒的因素,希望生产企业、注册部门对该产品生产过程中的技术要点给予关注,以期提高试剂盒的质量。Objective： To discuss the specific technical points of FOB Diagnostic Kits（by Colloidal Gold Method） in the process of production and registration. Methods： The reaction principle, the raw material and auxiliary material as well as relevant quality control during productive process were induced in this paper. Results and Conclusion： The factors which affect the quality of products were discussed. We do hope the manufacturer and registration office can pay more attention to the techniques of productive process,so as to improve the product quality of diagnostic kits.

关 键 词：便潜血检测试剂盒 胶体金法 技术要点 质量控制 

分 类 号：R197.39[医药卫生—卫生事业管理]