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
. 2022 Oct 6:2022:9447251.
doi: 10.1155/2022/9447251. eCollection 2022.

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Pei-Chin Lin  1 , Hung-Pin Chiu  1 , Fang-Yi Cheng  1 , Chih-Chun Chang  1   2 , Fang-Yeh Chu  1   3   4   5
Affiliations

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Pei-Chin Lin et al. Can J Infect Dis Med Microbiol. .

Abstract

Background: Rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection have been authorized for emergency use (EUA); however, the performance has not been fully evaluated in clinical contexts. This study aimed to provide evidence regarding the diagnostic performance of SARS-CoV-2 rapid antigen tests compared with the real-time reverse transcription-polymerase chain reaction (RT-PCR) test in the emergency department (ED) and community.

Methods: Patients who underwent SARS-CoV-2 rapid antigen tests using the VTRUST COVID-19 Antigen Rapid Test (TD-4531) and real-time RT-PCR on the same day in the ED or community from May 24, 2021, to June 24, 2021, were examined.

Results: Paired nasopharyngeal swabs were collected from 4022 suspected COVID-19 patients: 800 in the ED and 3222 in the community. Overall, 62 (1.54%) tested positive, 13 tested indeterminate, and 3947 tested negative by real-time RT-PCR. The sensitivity and specificity of the antigen test were 51.61% and 99.44% (overall), 62.50% and 99.61% (ED), and 31.82% and 99.40% (community), respectively. There were 30 false negatives and 22 false positives. Among the false negatives, 16.67% had a cycle threshold (Ct) value of <25.

Conclusion: The VTRUST COVID-19 Antigen Rapid Test showed comparable specificity as real-time RT-PCR for the ED and community, but the sensitivity was relatively low, especially when the Ct value was >25. This test can be useful for the rapid identification of infected subjects in an epidemic situation.

PubMed Disclaimer

Conflict of interest statement

The authors declare that there are no conflicts of interest regarding the publication of this article.

Figures

Figure 1
Figure 1
The sensitivity of the VTRUST COVID-19 Antigen Rapid Test with respect to Ct values of RT-PCR for the E gene. Ct cycle threshold; RT-PCR, reverse transcription-polymerase chain reaction; COVID-19 coronavirus disease 2019.
Figure 2
Figure 2
Sensitivity of the VTRUST COVID-19 Antigen Rapid Test with respect to Ct values of RT-PCR for the E gene in the ED and community testing site. RT-PCR, reverse transcription-polymerase chain reaction; ED, emergency department; Ct cycle threshold; COVID-19: coronavirus disease 2019.
See this image and copyright information in PMC

References

    1. Sohrabi C., Alsafi Z., O’Neill N., et al. World Health Organization declares global emergency: a review of the 2019 novel coronavirus (COVID-19) International Journal of Surgery . 2020;76:71–76. doi: 10.1016/j.ijsu.2020.02.034. - DOI - PMC - PubMed
    1. Centers for Disease Control, Taiwan National Infectious Disease Statistics System . Centers for Disease Control, Atlanta, GA, USA; 2022, https://nidss.cdc.gov.tw/nndss/disease?id=19CoV.
    1. Sun J. T., Huang C. Y., Tsai H. W., et al. The predictive and prognostic role of hematologic and biochemical parameters in the emergency department among coronavirus disease 2019 patients. The Chinese Journal of Physiology . 2021;64(6):p. 306. doi: 10.4103/cjp.cjp_77_21. - DOI - PubMed
    1. Kerr C. C., Mistry D., Stuart R. M., et al. Controlling COVID-19 via test-trace-quarantine. Nature Communications . 2021;12(1) doi: 10.1038/s41467-021-23276-9. - DOI - PMC - PubMed
    1. Habli Z., Saleh S., Zaraket H., Khraiche M. L. COVID-19 in-vitro diagnostics: State-of-the-art and challenges for rapid scalable and high-accuracy screening. Frontiers in Bioengineering and Biotechnology . 2020;8 doi: 10.3389/fbioe.2020.605702. - DOI - PMC - PubMed

LinkOut - more resources