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RESEARCH PRODUCT

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

Marina Di DomenicoMarina Di DomenicoAndrea MarottaDavide CastrianniPietro InternicolaNicola SalzanoFrancesca Di GaudioMariarosaria BoccellinoAlfredo De RosaCinzia Bettini

subject

medicine.medical_specialtyrespiratory disease COVID-19Coronavirus disease 2019 (COVID-19)Health Toxicology and MutagenesisSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)cyto-salivary testRT-PCRDiagnostic accuracyImmunologic TestsGastroenterologyAsymptomaticSensitivity and SpecificityArticlelateral flow testLateral flow test03 medical and health sciences0302 clinical medicineAntigenInternal medicinemedicineHumansImmunologic Test030212 general & internal medicinePandemics030304 developmental biology0303 health sciencesbusiness.industrySARS-CoV-2Public Health Environmental and Occupational HealthRCOVID-19Gold standard (test)Antigen testSARS-CoV-2.MedicineELISAmedicine.symptombusinessHuman

description

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.

10.3390/ijerph18126310http://dx.doi.org/10.3390/ijerph18126310