Sakai-Tagawa Yuko, Yamayoshi Seiya, Halfmann Peter J, Kawaoka Yoshihiro
Division of Virology, Department of Microbiology and Immunology, Institute of Medical Science, University of Tokyo, Tokyo 108-8639, Japan.
International Research Center for Infectious Diseases, Department of Special Pathogens, Institute of Medical Science, University of Tokyo, Tokyo 108-8639, Japan.
Viruses. 2021 Oct 29;13(11):2183. doi: 10.3390/v13112183.
Rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are useful for rapid diagnosis in a variety of settings. Although many kinds of RATs are available, their respective sensitivity has not been compared. Here, we examined the sensitivity of 27 RATs available in Japan for the detection of the SARS-CoV-2 delta variant. All of the RATs tested detected the delta variant albeit with different sensitivities. Nine RATs (ESPLINE SARS-CoV-2, ALSONIC COVID-19 Ag, COVID-19 and Influenza A+B Antigen Combo Rapid Test, ImmunoArrow SARS-CoV-2, Fuji Dri-chem immuno AG cartridge COVID-19 Ag, 2019-nCoV Ag rapid detection kit, Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit, and Rabliss SARS-CoV-2 antigen detection kit COVID19 AG) showed superior sensitivity to the isolated delta variant. Although actual clinical specimens were not examined, the detection level of most of the RATs was 7500 pfu, indicating that individuals whose test samples contained less virus than that would be considered negative. Therefore, it is important to bear in mind that RATs may miss individuals shedding low levels of infectious virus.
基于侧向流动免疫分析的新型冠状病毒肺炎快速抗原检测（RATs）在多种情况下对快速诊断很有用。尽管有多种RATs可供使用，但它们各自的灵敏度尚未进行比较。在此，我们检测了日本市面上27种RATs对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）Delta变异株的检测灵敏度。所有测试的RATs都能检测到Delta变异株，尽管灵敏度不同。9种RATs（ESPLINE SARS-CoV-2、ALSONIC新型冠状病毒肺炎抗原、新型冠状病毒肺炎和甲型+乙型流感抗原联合快速检测、ImmunoArrow SARS-CoV-2、富士干式化学免疫AG试剂盒新型冠状病毒肺炎抗原、2019新型冠状病毒抗原快速检测试剂盒、唾液SARS-CoV-2（2019新型冠状病毒）抗原检测试剂盒和Rabliss SARS-CoV-2抗原检测试剂盒COVID19 AG）对分离出的Delta变异株显示出更高的灵敏度。尽管未检测实际临床标本，但大多数RATs的检测水平为7500个空斑形成单位（pfu），这表明检测样本中病毒含量低于该水平的个体将被视为阴性。因此，必须牢记，RATs可能会漏检传染性病毒载量低的个体。
