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

Marina Di Domenico, Alfredo De Rosa, Francesca Di Gaudio, Pietro Internicola, Cinzia Bettini, Nicola Salzano, Davide Castrianni, Andrea Marotta and Mariarosaria Boccellino
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Marina Di Domenico: Department of Precision Medicine, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
Alfredo De Rosa: Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
Francesca Di Gaudio: Department of Health of the Region of Sicily, CRQ (Regional Laboratory Quality Control Centre), 90145 Palermo, Italy
Pietro Internicola: Anesthesia and Reanimation Service “Santa Maria della Pietà” Hospital, 80026 Casoria, Italy
Cinzia Bettini: Laboratory and Clinical Analysis Service “Santa Maria della Pietà” Hospital, 80026 Casoria, Italy
Nicola Salzano: Italian Ministry of Health, USMAF SASN, 80133 Naples, Italy
Davide Castrianni: Italian Ministry of Health, USMAF SASN, 80133 Naples, Italy
Andrea Marotta: Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
Mariarosaria Boccellino: Department of Precision Medicine, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy

IJERPH, 2021, vol. 18, issue 12, 1-9

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.

Keywords: respiratory disease COVID-19; SARS-CoV-2; ELISA; cyto-salivary test; RT-PCR; lateral flow test (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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