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. 2022 Jun;28(6):840-843.
doi: 10.1016/j.jiac.2022.02.027. Epub 2022 Mar 7.

A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag

Yuto Takeuchi  1 , Yusaku Akashi  2 , Yoshihiko Kiyasu  3 , Norihiko Terada  4 , Yoko Kurihara  5 , Daisuke Kato  6 , Takashi Miyazawa  7 , Shino Muramatsu  8 , Yuki Shinohara  9 , Atsuo Ueda  10 , Shigeyuki Notake  11 , Koji Nakamura  12 , Hiromichi Suzuki  13
Affiliations

A prospective evaluation of diagnostic performance of a combo rapid antigen test QuickNavi-Flu+COVID19 Ag

Yuto Takeuchi et al. J Infect Chemother. 2022 Jun.

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.

Keywords: Antigen test; COVID-19; Immunochromatography; Influenza; QuickNavi-Flu+COVID19 Ag; SARS-CoV-2.

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Conflict of interest statement

Denka Co., Ltd., provided fees for research expenses and QuickNavi-Flu+COVID19 Ag, QuickNavi-COVID19 Ag, and QuickNavi-Flu2 without charge. Hiromichi Suzuki received a lecture fee from Otsuka Pharmaceutical Co., Ltd., regarding this study. Daisuke Kato, Takashi Miyazawa, Shino Muramatsu and Yuki Shinohara belong to Denka Co., Ltd., the developer of the QuickNavi-Flu+COVID19 Ag.

References

    1. World Health Organization Coronavirus disease (COVID-19) situation reports. 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situatio...
    1. Thein T.-L., Ang L.W., Young B.E., Chen M.I.-C., Leo Y.-S., Lye D.C.B. Differentiating coronavirus disease 2019 (COVID-19) from influenza and dengue. Sci Rep. 2021;11:19713. doi: 10.1038/S41598-021-99027-Z. - DOI - PMC - PubMed
    1. Peeling R.W., Olliaro P.L., Boeras D.I., Fongwen N. Scaling up COVID-19 rapid antigen tests: promises and challenges. Lancet Infect Dis. 2021;21:e290–e295. doi: 10.1016/S1473-3099(21)00048-7. - DOI - PMC - PubMed
    1. Otsuka Pharmaceutical Company Limited . News releases. Otsuka Pharmaceutical Co., Ltd.; 2021. Quick NaviTM - flu+COVID-19 Ag receives regulatory approval in Japan as a combo, rapid diagnostic kit for influenza and COVID-19- simultaneous testing for both viruses using a single test sample.https://www.otsuka.co.jp/en/company/newsreleases/2021/20210616_1.html
    1. National Institute of Infectious Diseases Current Situation of Infection. 2021:2021. https://www.niid.go.jp/niid/en/2019-ncov-e/10636-covid19-ab50th-en.html September 1.

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