LiCA^(■)灭活型保存液对新冠病毒抗原灭活效果的影响  

Effect of LiCA^(R)inactivated preservation solution on the inactivated COVID⁃19 antigen

作　　者：张宇亭 解辉 王建新 王玺 于明航 ZHANG Yuting;XIE Hui;WANG Jianxin;WANG Xi;YU Minghang(National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China;Beijing Key Laboratory of Emerging Infectious Diseases,Institute of Infectious Diseases,Beijing Ditan Hospital,Capital Medical University;Beijing Institute of Infectious Diseases;National Center for Infectious Diseases,Beijing Ditan Hospital,Capital Medical University;Department of Infectious Diseases,Yantai Qishan Hospital)

机构地区：[1]传染病溯源预警与智能决策全国重点实验室,北京100015 [2]首都医科大学附属北京地坛医院传染病研究所,新发突发传染病研究北京市重点实验室 [3]北京市感染性疾病研究中心 [4]国家传染病医学中心,首都医科大学附属北京地坛医院 [5]山东省烟台市奇山医院感染科

出　　处：《山西医科大学学报》2025年第2期188-192,共5页Journal of Shanxi Medical University

基　　金：国家重点研发计划资助项目(2023YFC0872400,2023YFC2306003);北京重大呼吸道传染病研究中心项目(BJRID2024-010);北京市高层次公共卫生技术人才建设项目(领军人才-03-08);首都医科大学附属北京地坛医院院内科研基金项目(DTQL-202405)。

摘　　要：目的评估LiCA^(■)高敏新冠抗原检测系统对新冠灭活病毒标本抗原检测的效率及其临床应用价值。方法采用LiCA^(■)高敏新冠抗原检测系统评估待测病毒保存液对新冠抗原的灭活效果;依据CLSIEP05-A3和CLSIEP26-A方案,对系统批内差、批间差进行分析评估;最后利用该系统对新冠患者灭活后的鼻拭子标本进行抗原检测,验证其对临床样本检测效果。结果友康病毒采样管保存液(阳性对照)病毒灭活率99.92%,其余7种研发用病毒保存液灭活率均≥99.24%。批内重复变异系数(CV)≤10%,批间重复变异系数(CV)≤15%,符合实验要求。利用该系统对新冠患者灭活后鼻拭子的抗原进行检测,感染后第1~7天抗原由阳性逐渐转为阴性,符合病毒感染的规律。结论LiCA^(■)高敏新冠抗原检测系统对灭活型新冠病毒的检测安全有效。Objective To evaluate the efficiency and the clinical application value of LiCA^(■)high-sensitivity COVID-19 antigen detec-tion system for antigen detection in inactivated novel coronavirus specimens.Methods The LiCA®detection system was used to evaluate the inactivation effect of the tested virus preservation solutions on COVID-19 antigen.The intra-batch variation and inter-batch variation of the system were analyzed according to the CLSIEP05-A3 and CLSIEP26-A protocol.Finally,the system was used to detect antigen in inactivated nasal swab samples of patients with COVID-19 to verify its detection effect on clinical samples.Results The virus inactivation rate of Youkang virus sampling tube storage solution(positive control)reaches 99.92%,and the inactivation rates of the remaining 7 kinds of virus preservation solutions were≥99.24%.The coefficient of variation(CV)within the batch was less than or equal to 10%,and the CV of the inter-batch repetition was less than or equal to 15%,which meets the actual use requirements.After detection by the system,nasopharyngeal swabs for rapid antigen testing were detected for COVID-19,the positive antigen gradu-ally turned negative from day 1 to day 7 after infection,which accords with the law of virus infection.Conclusion LiCA®high-sensi-tivity COVID-19 antigen test system is safe and effective for the detection of inactivated COVID-19.

关 键 词：新型冠状病毒感染 抗原 LiCA^(■) 灭活病毒 批内差 批间差 鼻拭子 

分 类 号：R446.5[医药卫生—诊断学]