Diagnostic Performance of a Rapid Antigen Test Compared with the Reverse Transcription Polymerase Chain Reaction for SARS-CoV-2 Detection in Asymptomatic Individuals Referring to a Drive-in Testing Facility

Quick and reliable identification of severe acute respiratory syndrome coronavirus SARS-CoV-2 in the population is required to manage the COVID-19 pandemic. This is a prospective observational study of diagnostic accuracy. Paired swab samples from 317 asymptomatic individuals referring to a drive-in...

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Bibliographic Details
Published in:COVID 2021-12, Vol.1 (4), p.784-789
Main Authors: Lombardo, Fabio, Triolo, Gianluca, Yang, Biao, Liu, Zhonghua, Maiuri, Paolo, Orsini, Emanuele, Jin, Wei, Zacchigna, Serena, Marcello, Alessandro
Format: Article
Language:English
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Summary:Quick and reliable identification of severe acute respiratory syndrome coronavirus SARS-CoV-2 in the population is required to manage the COVID-19 pandemic. This is a prospective observational study of diagnostic accuracy. Paired swab samples from 317 asymptomatic individuals referring to a drive-in testing facility were tested in parallel by means of the rapid antigen test developed by Jiangsu Bioperfectus Technologies and routine nucleic acid detection. Overall specificity was 100% and sensitivity was 49% but reached 87% at higher viral loads (Ct < 25). In this study, the antigen detection test showed high specificity and good sensitivity in asymptomatic individuals carrying higher viral loads. The assay performance worsened with lower viral loads, making it useful when a rapidly deployable test is essential and to assess a potential risk of immediate transmission in the community, but not recommended for testing asymptomatic individuals.
ISSN:2673-8112
2673-8112
DOI:10.3390/covid1040063