摘要
目的探讨新型冠状病毒(SARS-CoV-2)抗原检测的临床应用价值及其诊断效能。方法随机选取2022年3—6月上海市松江区某方舱无症状SARS-CoV-2感染初期患者340例、某封控小区居民4294名、某管控小区居民420名、某防范小区居民800名进行SARS-CoV-2抗原检测,采用核酸双试剂复核SARS-CoV-2抗原阳性结果。采用受试者工作特征(ROC)曲线评价SARS-CoV-2抗原检测诊断SARS-CoV-2感染的效能。结果方舱SARS-CoV-2感染患者进舱第1天抗原检测阳性率为81.0%。封控小区和管控小区居民抗原检测真阳性率平均为43.1%。核酸检测阳性率明显高于抗原检测真阳性率(P<0.01),2种检测方法的一致性较差(Kappa=0.266)。SARS-CoV-2阳性患者抗原转阴时间显著早于核酸转阴时间(P<0.05),且循环阈值(Ct)>28时抗原试剂检测线(T线)不显色。ROC曲线分析结果显示,SARS-CoV-2抗原检测诊断SARS-CoV-2感染的曲线下面积为0.773。结论SARS-CoV-2抗原检测可用于SARS-CoV-2的筛查,但不能替代核酸检测。
Objective To investigate the clinical application value and diagnostic efficacy of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen determination.Methods From March to June 2022,340 asymptomatic patients at the initial stage of corona virus disease 2019(COVID-19)in a shelter in Songjiang District,4294 residents in a sealed control area,420 residents in a management control area and 800 residents in a prevention area were randomly enrolled for the determination of SARS-CoV-2 antigen.The positive SARS-CoV-2antigen determination results were rechecked with double-reagent nucleic acid.Receiver operating characteristic(ROC)curve was used to evaluate the efficiency of SARS-CoV-2 antigen qualitative determination for the diagnosis of SARS-CoV-2 infection.Results The positive rate of SARS-CoV-2 antigen determination on the first day of shelter was 81.0%,and the average true positive rate of SARS-CoV-2 antigen determination in sealed control area and management control area was 43.1%.The positive rate of nucleic acid test was higher than that of SARS-CoV-2antigen determination(P<0.01),and the consistency of the 2 methods was poor(Kappa value was 0.266).The turn-to-negative time of SARS-CoV-2 antigen determination was earlier than that of nucleic acid test(P<0.05),and the antigen determination line(T line)did not show colour when the cycle threshold(Ct)value was>28.The area under curve was 0.773 for SARS-CoV-2 antigen determination.Conclusions Antigen determination can be used as an auxiliary method in the early screening of SARS-CoV-2,but it can not replace nucleic acid test.
作者
杨丹平
王宏
王灿
陈卫
杨爱平
YANG Danping;WANG Hong;WANG Can;CHEN Wei;YANG Aiping(Shanghai Songjiang Jiuting Hospital,Shanghai 201615,China)
出处
《检验医学》
CAS
2023年第1期28-31,共4页
Laboratory Medicine
关键词
新型冠状病毒
抗原检测
核酸检测
诊断效能
Severe acute respiratory syndrome coronavirus 2
Antigen qualitative determination
Nucleic acid test
Diagnostic efficacy
