山西医科大学学报2025，Vol.56Issue(2)：188-192,5.DOI:10.13753/j.issn.1007-6611.2025.02.011
LiCA®灭活型保存液对新冠病毒抗原灭活效果的影响
Effect of LiCA® inactivated preservation solution on the inactivated COVID-19 antigen
摘要
Abstract
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Key words
novel coronavirus infection/antigen/LiCA®/inactivated virus/intra-batch variation/inter-batch varia-tion/nose swab分类
临床医学引用本文复制引用
张宇亭,解辉,王建新,王玺,于明航..LiCA®灭活型保存液对新冠病毒抗原灭活效果的影响[J].山西医科大学学报,2025,56(2):188-192,5.基金项目
国家重点研发计划资助项目(2023YFC0872400,2023YFC2306003) （2023YFC0872400,2023YFC2306003）
北京重大呼吸道传染病研究中心项目(BJRID2024-010) （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) （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) （DTQL-202405）
