摘要
目的构建科学、合理、有效、可行的新型冠状病毒(简称新冠病毒)抗原/抗体检测全过程闭环管控体系。方法对比核酸检测与抗原/抗体检测的特点,结合新冠病毒特性及当前国家疫情防控实际,探讨构建体系的具体举措。结果通过在抗原/抗体检测产品的生产、流通、使用、报告、回收处理及跟踪溯源、数据管理等环节开展管控,可形成以产品唯一识别码(UDI)为基础的抗原/抗体检测全过程闭环管控体系。结论构建的闭环管控体系可分区、分类逐步推广实施,以更科学、合理地实现新冠病毒抗原/抗体检测的安全性、真实性、可行性、可控性。
Objective To construct a scientific,reasonable,effective and feasible closed-loop management and control system for the coronavirus disease 2019(COVID-19) antigen/antibody detection.Methods Based on the characteristics of COVID-19 and the actual situation of epidemic prevention and control,the specific measures for constructing the system were investigated by comparing the characteristics of nucleic acid detection and antigen/antibody detection.Results Through the control of the production(P),circulation(S),usage(U),reporting(R),recycling(R),database management(D),tracking and traceability(T) of antigen/antibody detection products,a closed-loop control system based on the unique device identification(UDI) of the products could be constructed.Conclusion The constructed closed-loop management and control system can be gradually popularized and implemented by division and classification,so as to realize the safety,authenticity,feasibility and controllability of COVID-19 antigen/antibody detection more scientifically and reasonably.
作者
温天文
巫军
袁学军
肖大伟
刁勇
张旭雯
WEN Tianwen;WU Jun;YUAN Xuejun;XIAO Dawei;DIAO Yong;ZHANG Xuwen(Jiangsu CO-SIN0 Biotechnology Co.,Ltd.,Taizhou,Jiangsu,China 225300;Nanjing Weilv Biotechnology Co.,Ltd.,Nanjing,Jiangsu,China 210032;Medical Clinical Center,High-Tech Hospital of Nanjing Gulou Hospital Group,Nanjing,Jiangsu,China 210032;School of Medicine,Huaqiao University,Quanzhou,Fujian,China 362021)
出处
《中国药业》
CAS
2023年第6期7-10,共4页
China Pharmaceuticals
关键词
新型冠状病毒
抗原/抗体检测
唯一识别码
闭环管控
药品监管
COVID-19
antigen/antibody detection
unique device identification
closed-loop management and control
drug administration
