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. 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.

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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.
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