A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag. Issue 6 (June 2022)

• Record Type: Journal Article
• Authors: Takeuchi, Yuto; Akashi, Yusaku; Kiyasu, Yoshihiko; Terada, Norihiko; Kurihara, Yoko; Kato, Daisuke; Miyazawa, Takashi; Muramatsu, Shino; Shinohara, Yuki; Ueda, Atsuo; Notake, Shigeyuki; Nakamura, Koji; Suzuki, Hiromichi
• Is Part Of: Journal of infection and chemotherapy. Volume 28:Issue 6(2022)
• Page Start: 840
• Page End: 843
• Publication Date: 2022-06
• Subjects: Antigen test -- Immunochromatography -- QuickNavi-Flu+COVID19 Ag -- COVID-19 -- SARS-CoV-2 -- Influenza; Chemotherapy -- Periodicals; Infection -- Periodicals; Communicable diseases -- Chemotherapy -- Periodicals; 615.5805
• DOI: 10.1016/j.jiac.2022.02.027
• Languages: English
• ISSNs: 1341-321X

Abstract

Abstract: Introduction: Since respiratory sample collection is an uncomfortable experience, simultaneous detection of pathogens with a single swab is preferable. We prospectively evaluated the clinical performance of a newly developed antigen test QuickNavi-Flu+COVID19 Ag (Denka Co., Ltd., Tokyo, Japan) which can detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses at the same time with a single testing device. Methods: We included those who were suspected of contracting coronavirus disease 2019 (COVID-19) and were referred to a PCR center at Ibaraki prefecture in Japan, between August 2, 2021 to September 13, 2021, when the variant carrying L452R spike mutation of SARS-CoV-2 were prevalent. Additional nasopharyngeal samples and anterior nasal samples were obtained for the antigen test and were compared with a reference real-time reverse transcription PCR (RT-PCR) using nasopharyngeal samples. Results: In total, 1510 nasopharyngeal samples and 862 anterior nasal samples were evaluated. During the study period, influenza viruses were not detected by QuickNavi-Flu+COVID19 Ag and reference real-time RT-PCR. For SARS-CoV-2 detection in nasopharyngeal samples, the sensitivity and specificity of the antigen test were 80.9% and 99.8%, respectively. The sensitivity and specificity using anterior nasal samples were 67.8% and 100%, respectively. In symptomatic cases, the sensitivities increased to 88.3% with nasopharyngeal samples and 73.7% with anterior nasal samples. There were three cases of discrepant results between the antigen test and the real-time RT-PCR. All of them were positive with the antigen test but negative with the real-time RT-PCR in SARS-CoV-2 detection. Conclusion: A combo kit, QuickNavi-Flu+COVID19 Ag, showed an acceptable sensitivity and sufficient specificity for SARS-CoV-2 detection, especially using nasopharyngeal sample collected from symptomatic patients.