新型冠状病毒抗原自测应用于隔离人员筛查的初步评价  

Preliminary evaluation on applying self-detection of SARS-CoV-2 antigen among people in quarantine

作　　者：杨慧萍[1] 徐佳楠[1] 刘李[1] 冯玉亮 黄忠平 潘明[1] Yang Huiping;Xu Jianan;Liu Li;Feng Yuliang;Huang Zhongping;Pan Ming(Institute of Microbiological Detection,Sichuan Provincial Center for Disease Control and Prevention,Chengdu 610041,China)

机构地区：[1]四川省疾病预防控制中心微生物检验所,成都610041

出　　处：《国际病毒学杂志》2022年第5期374-377,共4页International Journal of Virology

基　　金：四川省科技厅重点研发项目基金(2021YFQ0060)。

摘　　要：目的对新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)抗原检测试剂盒(胶体金免疫层析法)进行临床评价,初步评价其应用于隔离人员筛查的效果。方法采集172位隔离人员的临床平行样本(分别用于核酸和抗原检测)共516份,由研究人员和隔离人员分别采用胶体金免疫层析法进行SARS-CoV-2抗原的快速检测,同时在实验室进行核酸检测,计算阳性符合率、阴性符合率、总符合率和Kappa值。结果两种方法的总符合率为91.86%(95%CI:86.80%~95.09%),一致性分析Kappa系数为0.527(95%CI:0.318~0.736),0.4≤Kappa<0.8。研究人员和隔离人员自测结果的总符合率为99.42%(95%CI:96.78%~99.90%),一致性分析Kappa系数为0.944(95%CI:0.836~1.000),Kappa>0.8。结论胶体金免疫层析法检测SARS-CoV-2抗原在发病初期及病毒载量较高时有较好的检测效果,可应用于对隔离人员的现场筛查。但鉴于其方法的局限性,结果只能作为初步参考,最终的确认结果应以实时荧光PCR法结果为准。Objective To conduct clinical assessment of the antigen detection kit(colloidal gold immunochromatography method)for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)and to evaluate initially the application of the kit among people in quarantine.Methods A total of 516 clinical samples were collected in parallel from 172 quarantined persons(for nucleic acid and antigen detection,respectively).SARS-CoV-2 antigen was detected with the immunochromatographic assay by researcher and people in quarantine,respectively.The SARS-CoV-2 nucleic acid was tested in the laboratory by researcher.The positive coincidence rate,negative coincidence rate,total coincidence rate and Kappa value were calculated.Results The overall coincidence rate of the two methods was 91.86%(95%CI:86.80%-95.09%),and the Kappa coefficient of consistency analysis was 0.527(95%CI:0.318-0.736)with 0.4≤Kappa<0.8.The overall coincidence rate of researchers and people in quarantine was 99.42%(95%CI:96.78%-99.90%),and the Kappa coefficient of consistency analysis was 0.944(95%CI:0.836-1.000)with Kappa>0.8.Conclusions The colloidal gold immunochromatography assay could provide effective early diagnosis of SARS-CoV-2,and could be used for on-site screening among people in quarantine.The results of the assay should be used as a preliminary reference and should be confirmed by real time fluorescent PCR.

关 键 词：新型冠状病毒 抗原检测 隔离人员 

分 类 号：R446.6[医药卫生—诊断学]