Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant
Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant
Abstract IntroductionAntigen testing is essential in the clinical management of COVID-19. However, most evaluations of antigen tests have been performed before the emergence of the Omicron variant. Thus, an assessment of the diagnostic performance of antigen tests for the detection of SARS-CoV-2 during the circulation of Omicron variant is required. MethodsThis prospective observational study evaluated QuickNavi-COVID19 Ag, a rapid antigen detection test between December 2021 and February 2022 in Japan, using real-time reverse transcription (RT)-PCR as a reference. Two nasopharyngeal samples were simultaneously collected for antigen testing and for RT-PCR. Variant analysis of the SARS-CoV-2 genomic sequencing was also performed. ResultsIn total, nasopharyngeal samples were collected from 1,073 participants (417 positive; 919 symptomatic; 154 asymptomatic) for analysis. Compared with those of RT-PCR, the sensitivity, specificity, positive predictive value, and negative predictive value were 94.2% (95% CI: 91.6%–96.3%), 99.5% (95% CI: 98.7%–99.9%), 99.2% (95% CI: 97.8%–99.8%), and 96.5% (95% CI: 94.8%–97.7%), respectively. The sensitivity among symptomatic individuals was 94.3% (95% CI: 91.5%–96.4%). Overall, 85.9% of sequences were classified as Omicron sublineage BA.1, 12.4% were Omicron sublineage BA.2, and 1.6% were Delta B.1.617.2. (Delta variant). Most of the samples (87.1%) had Ct values <25. ConclusionsThe QuickNavi-COVID19 Ag test showed high diagnostic performance for the detection of the SARS-CoV-2 Omicron sublineages BA.1 and BA.2 from nasopharyngeal samples.
Nakamura Koji、Muramatsu Shino、Terada Norihiko、Akashi Yusaku、Kato Daisuke、Kiyasu Yoshihiko、Ueda Atsuo、Takeuchi Yuto、Kurihara Yoko、Suzuki Hiromichi、Kuwahara Miwa、Notake Shigeyuki
Department of Clinical Laboratory, Tsukuba Medical Center HospitalDenka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D DepartmentDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital||Department of Infectious Diseases, Faculty of Medicine, University of TsukubaDivision of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital||Department of Infectious Diseases, Faculty of Medicine, University of Tsukuba||Akashi Internal Medicine ClinicDenka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D DepartmentDepartment of Infectious Diseases, University of Tsukuba Hospital||Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital||Department of Infectious Diseases, Faculty of Medicine, University of TsukubaDepartment of Clinical Laboratory, Tsukuba Medical Center HospitalDepartment of Infectious Diseases, University of Tsukuba Hospital||Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center HospitalDepartment of Infectious Diseases, University of Tsukuba HospitalDepartment of Infectious Diseases, University of Tsukuba Hospital||Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital||Department of Infectious Diseases, Faculty of Medicine, University of TsukubaDenka Co., Ltd. Gosen Site, Research & Development Division, Reagent R&D DepartmentDepartment of Clinical Laboratory, Tsukuba Medical Center Hospital
医学研究方法医药卫生理论
Nasopharyngeal sampleSARS-CoV-2COVID-19Omicron variantQuickNavi-COVID19 Ag
Nakamura Koji,Muramatsu Shino,Terada Norihiko,Akashi Yusaku,Kato Daisuke,Kiyasu Yoshihiko,Ueda Atsuo,Takeuchi Yuto,Kurihara Yoko,Suzuki Hiromichi,Kuwahara Miwa,Notake Shigeyuki.Analytical performance of rapid antigen tests for the detection of SARS-CoV-2 during widespread circulation of the Omicron variant[EB/OL].(2025-03-28)[2025-04-26].https://www.medrxiv.org/content/10.1101/2022.05.17.22275034.点此复制
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