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Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection

De Rosa, Alfredo
Di Gaudio, Francesca
Internicola, Pietro
Bettini, Cinzia
Salzano, Nicola
Castrianni, Davide
Marotta, Andrea
Boccellino, Mariarosaria
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Journal article
Date
2021-06-10
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Biology
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DOI
https://doi.org/10.3390/ijerph18126310
Abstract
Background and aims: Quick and reliable diagnostic tools play an important role in controlling the spread of the SARS-Cov-2 pandemic. The aim of this study was to evaluate the diagnostic accuracy of a new cyto-salivary antigen test aimed at detecting the presence of antigens for SARS-CoV-2, as compared by the gold standard RT-PCR and a lateral flow test. Methods: A total of 433 healthy volunteers were enrolled in the study and the sensitivity and specificity of the new cyto-salivary antigen test were calculated, as compared to the RT-PCR nasopharyngeal swab and to the lateral flow test. Results: A total of 433 samples were collected and tested at the Mediterranean Fair in Palermo from February 2021 until April 2021. The new cyto-salivary antigen had a sensitivity of 100% and a specificity of 94.2%. The sensitivity and the specificity of the lateral flow test were 55% and 100%, respectively. Conclusions: The new cyto-salivary antigen test detected more positive cases than the RT-PCR in a sample of asymptomatic subjects, demonstrating to be a promising tool for a more sensitive diagnosis of COVID-19. Further studies are warranted to better characterize its diagnostic accuracy.
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Di Domenico, M.; De Rosa, A.; Di Gaudio, F.; Internicola, P.; Bettini, C.; Salzano, N.; Castrianni, D.; Marotta, A.; Boccellino, M. Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection. Int. J. Environ. Res. Public Health 2021, 18, 6310. https://doi.org/10.3390/ijerph18126310
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International Journal of Environmental Research and Public Health, Vol. 18, No. 12
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