恒温扩增即时检测设备检测新冠病毒的性能分析及临床评价  

Performance analysis and clinical evaluation of loop-mediated isothermalamplification-based point-of-care testing equipment for detection of SARS-CoV-2

作　　者：孙菲 艾晓娟 李名慧 解亚平 刘娟 黄帅武 SUN Fei;AI Xiaojuan;LI Minghui;XIE Yaping;LIU Juan;HUANG Shuaiwu(Hunan International Travel Health Care Center(Portal Clinic of Changsha Customs),Changsha,Hunan 410004,China;Sansure Biotech Inc.,Changsha,Hunan 410205,China)

机构地区：[1]湖南国际旅行卫生保健中心(长沙海关口岸门诊部),湖南长沙410004 [2]圣湘生物科技股份有限公司,湖南长沙410205

出　　处：《实用预防医学》2025年第3期377-381,共5页Practical Preventive Medicine

基　　金：海关总署科研项目(2022HK094);湖南省自然科学-青年基金项目(2023JJ40269)。

摘　　要：目的对恒温扩增即时检测(point-of-care testing,POCT)设备检测新型冠状病毒(severe acute respiratory syndromecoronavirus 2,SARS-CoV-2)进行性能验证及临床应用评价,综合评估其是否满足临床和口岸快速即时检测需求。方法分别以不同浓度的SARS-CoV-2阳性样本、其他55种具有同源性的病原体样本以及199例临床受试者样本作为待测对象,对恒温扩增POCT设备开展最低检出限、交叉反应、抗干扰研究、精密度、检测时间等方面的性能验证,并与荧光PCR法进行对比检测,全面评估其敏感度、特异性、阳性样本检出率。结果最低检测限为2.0×10^(3) copies/ml;与其他55种病原体之间均无竞争性干扰;对于阴性样品和中浓度样品,批内及批间检测重复性均为100.00%;对于临界浓度样品,3个批间POCT设备的重复性为99.68%;不同区域病毒样本检测重复性均为100.00%;与传统荧光PCR检测结果相比,敏感度为97.04%、特异性为100.00%、总符合率为97.48%(P=0.063);当Ct值<35时,阳性检出率为100.00%、当35≤Ct≤40时,阳性检出率为89.58%;非专业人员与经专业培训后的人员检测对比试验结果显示,阳性符合率为99.41%、阴性符合率为100.00%、总符合率为99.50%,Kappa值=0.981,P<0.001;阳性样本检出平均时间为9.95 min。结论该POCT设备灵敏度高、特异性高、检出时限短等特点,具有操作简便、快速、人员使用限制性小等优势,能够满足实际应用中多种场合进行即时检测需求。Objective To validate the performance and evaluate the clinical application of loop-mediated isothermalamplification-based point-of-care testing(POCT)equipment for detecting severe acute respiratory syndrome coronavirus2(SARS-CoV-2),and to comprehensively assess whether the POCT equipment meets the needs of rapid and immediate detectionin clinical practice and ports.Methods Different concentrations of SARS-CoV-2-positive samples,samples of 55 kinds ofother homologous pathogens and specimens from 199 clinical subjects were used as the test subjects.We verified the performance ofloop-mediated isothermal amplification-based POCT equipment in terms of the minimum detection limit,cross-reaction,anti-interference research,precision and detection time,and then made a comparison between the detection results fromloop-mediated isothermal amplification-based POCT equipment and fluorescent PCR assay.The sensitivity,specificity anddetection rate of the positive samples were evaluated comprehensively.Results The minimum detection limit was2.0×10^(3) copies/ml.There was no competitive interference with 55 kinds of other pathogens.As for the negative samples andmedium concentration samples,the repeatabilities of in-lot and inter-lot detection were both 100.00%.As for samples of criticalconcentration,the repeatability of the POCT equipment among three batches was 99.68%.The repeatability of virus samples indifferent regions was 100.00%.Compared with the detection results from traditional fluorescent PCR,the sensitivity,specificityand total coincidence rate were 97.04%,100.00%and 97.48%(P=0.063)respectively.The positive detection rate was 100.00%when the Ct value was<35,and the positive detection rate was 89.58%when the value was 35≤Ct≤40.The results detected bynon-professionals and professionally-trained personnel displayed that the positive coincidence rate,negative coincidence rate andtotal coincidence rate were 99.41%,100.00%and 99.50%respectively,with the Kappa value being 0.981 and P<0.001.Theaverage time for detecting

关 键 词：新型冠状病毒 恒温扩增 性能验证 即时检测 

分 类 号：R563.14[医药卫生—呼吸系统]