Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Oct;27(10):1489-1492.
doi: 10.1016/j.jiac.2021.07.005. Epub 2021 Jul 9.

Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

Yoshihiko Kiyasu  1 , Yuto Takeuchi  2 , Yusaku Akashi  3 , Daisuke Kato  4 , Miwa Kuwahara  5 , Shino Muramatsu  6 , Shigeyuki Notake  7 , Atsuo Ueda  8 , Koji Nakamura  9 , Hiroichi Ishikawa  10 , Hiromichi Suzuki  11
Affiliations

Prospective analytical performance evaluation of the QuickNavi™-COVID19 Ag for asymptomatic individuals

Yoshihiko Kiyasu et al. J Infect Chemother. 2021 Oct.

Abstract

Introduction: Antigen testing may help screen for and detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in asymptomatic individuals. However, limited data regarding the diagnostic performance of antigen tests for this group are available.

Methods: We used clinical samples to prospectively evaluate the analytical and clinical performance of the antigen test QuickNavi™-COVID19 Ag. This study was conducted at a PCR center between October 7, 2020 and January 9, 2021. Two nasopharyngeal samples per patient were obtained with flocked swabs; one was used for the antigen test, and the other for real-time reverse transcription PCR (RT-PCR). The diagnostic performance of the antigen test was compared between asymptomatic and symptomatic patients, and the RT-PCR results were used as a reference.

Results: Among the 1934 collected samples, 188 (9.7%) demonstrated detection of SARS-CoV-2 by real-time RT-PCR; 76 (40.4%) of these 188 samples were from asymptomatic individuals, and over half of the total samples were asymptomatic (1073; 55.5%). The sensitivity of the antigen test was significantly lower for the asymptomatic group than for symptomatic patients (67.1% vs. 89.3%, respectively, p < 0.001). The specificity was 100% for both groups, and no false positives were observed among all 1934 samples. The median cycle threshold value for the asymptomatic group was significantly higher than that of the symptomatic group (24 vs. 20, p < 0.001).

Conclusions: The QuickNavi™-COVID19 Ag showed lower sensitivity for the asymptomatic group than for symptomatic patients. However, its specificity was consistently high, and no false positives were found in this study.

Keywords: Asymptomatic patient; COVID-19; Nasopharyngeal sample; QuickNavi™-COVID19 Ag; SARS-CoV-2.

PubMed Disclaimer

Conflict of interest statement

Denka Co., Ltd. Provided fees for research expenses and provided the QuickNavi-COVID19 Ag kits without charge. Hiromichi Suzuki received a lecture fee from Otsuka Pharmaceutical Co., Ltd. regarding this study. Daisuke Kato, Miwa Kuwahara, and Shino Muramatsu belong to Denka Co., Ltd., the developer of the QuickNavi™ -COVID19 Ag.

Figures

Fig. 1
Fig. 1
Ct values of samples from symptomatic and asymptomatic subjects. The number next to each box indicates the median Ct value.
See this image and copyright information in PMC

References

    1. World Health Organisation Coronavirus disease (COVID-19) weekly epidemiological update and weekly operational update. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situatio... (accessed May 26, 2020).
    1. Chinazzi M., Davis J.T., Ajelli M., Gioannini C., Litvinova M., Merler S., et al. The effect of travel restrictions on the spread of the 2019 novel coronavirus (COVID-19) outbreak. Science. 2020;368:395–400. doi: 10.1126/science.aba9757. - DOI - PMC - PubMed
    1. Wilson M.E., Chen L.H. Re-starting travel in the era of COVID-19: preparing anew. J Trav Med. 2020;27 doi: 10.1093/jtm/taaa108. - DOI - PMC - PubMed
    1. Bielecki M., Patel D., Hinkelbein J., Komorowski M., Kester J., Ebrahim S., et al. Air travel and COVID-19 prevention in the pandemic and peri-pandemic period: a narrative review. Trav Med Infect Dis. 2021;39 doi: 10.1016/j.tmaid.2020.101915. - DOI - PMC - PubMed
    1. Younes N., Al-Sadeq D.W., AL-Jighefee H., Younes S., Al-Jamal O., Daas H.I., et al. Challenges in laboratory diagnosis of the novel coronavirus SARS-CoV-2. Viruses. 2020;12:582. doi: 10.3390/v12060582. - DOI - PMC - PubMed

Publication types

Substances