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.
【저자키워드】 SARS-CoV-2, RT-PCR, ELISA, Lateral flow test, respiratory disease COVID-19, cyto-salivary test, 【초록키워드】 pandemic, SARS-CoV-2 pandemic, diagnostic, RT-PCR, Antigen, Spread, Nasopharyngeal swab, sensitivity, specificity, Diagnostic accuracy, Lateral flow test, Accuracy, Sensitivity and specificity, gold, antigens, gold standard, asymptomatic subjects, positive, RT-PCR nasopharyngeal swab, enrolled, tested, collected, evaluate, calculated, diagnosis of COVID-19, Fair, healthy volunteer, 【제목키워드】 Test, detection, Diagnostic accuracy, New,