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

Author

Listed:
  • Marina Di Domenico

    (Department of Precision Medicine, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
    Department of Biology, College of Science and Technology, Temple University, Philadelphia, PA 19122, USA
    These authors contributed equally to this work.)

  • Alfredo De Rosa

    (Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
    These authors contributed equally to this work.)

  • Francesca Di Gaudio

    (Department of Health of the Region of Sicily, CRQ (Regional Laboratory Quality Control Centre), 90145 Palermo, Italy
    These authors contributed equally to this work.)

  • 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)

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.

Suggested Citation

  • Marina Di Domenico & Alfredo De Rosa & Francesca Di Gaudio & Pietro Internicola & Cinzia Bettini & Nicola Salzano & Davide Castrianni & Andrea Marotta & Mariarosaria Boccellino, 2021. "Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection," IJERPH, MDPI, vol. 18(12), pages 1-9, June.
    • Handle: RePEc:gam:jijerp:v:18:y:2021:i:12:p:6310-:d:572726
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    References listed on IDEAS

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    1. Edith Lahner & Emanuele Dilaghi & Claudio Prestigiacomo & Giuliano Alessio & Laura Marcellini & Maurizio Simmaco & Iolanda Santino & Giovanni Battista Orsi & Paolo Anibaldi & Adriano Marcolongo & Brun, 2020. "Prevalence of Sars-Cov-2 Infection in Health Workers (HWs) and Diagnostic Test Performance: The Experience of a Teaching Hospital in Central Italy," IJERPH, MDPI, vol. 17(12), pages 1-12, June.
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