一种新型冠状病毒抗原检测试剂性能分析和临床评价  

Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance

作　　者：姜晓路 杜明秋 羊兰翠 范晨霞 郑明 JIANG Xiaolu;DU Mingqiu;YANG Lancui;FAN Chenxia;ZHENG Ming(Zhejiang Institute of Medical Device Testing,Hangzhou,310018;Hangzhou Singclean Medical Products Co.Ltd.,Hangzhou,310018)

机构地区：[1]浙江省医疗器械检验研究院,杭州市310018 [2]杭州协合医疗用品有限公司,杭州市310018

出　　处：《中国医疗器械杂志》2023年第1期99-105,共7页Chinese Journal of Medical Instrumentation

摘　　要：目的快速筛查包括无症状在内的新型冠状病毒(COVID-19)感染者。方法使用胶体金免疫层析技术建立一种抗原快速检测试剂,进行分析性能评估,验证其临床应用。结果该检测试剂的最低检出限为9.75×10^(2)TCID_(50)/mL;测试29种常见呼吸道病原体高浓度样本均无交叉反应和干扰。临床样本测试,诊断灵敏度为98.56%,特异性为99.00%,总符合率为98.85%;一致性检验Kappa值为0.9745;对不同Ct值阳性样本分层分析,每个层级内符合率均大于95%。结论该试剂检测性能优异,检测速度快,操作便携,可作为现有核酸检测法的补充手段,用于新型冠状病毒的早期筛查。Objective To rapidly screen patients with novel coronavirus pneumonia(COVID-19)infection including asymptomatic ones.Method Established a rapid detection test kit,and evaluated analytical and clinical performance of it.Result The minimum limit of detection of the reagent was 9.75×10^(2) TCID_(50)/mL;there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested.The diagnostic sensitivity of clinical samples was 98.56%,specificity was 99.00%,and the total coincidence rate was 98.85%;the consistency test Kappa value is 0.9745.The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%.Conclusion This COVID-19 antigen test kit with excellent detection performance,fast detection speed,and portable operation.It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.

关 键 词：新型冠状病毒感染 严重急性呼吸系统综合征冠状病毒2 分析性能评估 体外诊断 

分 类 号：R197[医药卫生—卫生事业管理]