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

Int J Environ Res Public Health. 2021 Jun 10;18(12):6310. doi: 10.3390/ijerph18126310.


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: ELISA; RT-PCR; SARS-CoV-2; cyto-salivary test; lateral flow test; respiratory disease COVID-19.

MeSH terms

  • COVID-19*
  • Humans
  • Immunologic Tests
  • Pandemics
  • SARS-CoV-2*
  • Sensitivity and Specificity