Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection

Leonardo Miscio, Antonio Olivieri, Francesco Labonia, Gianfranco De Feo, Paolo Chiodini, Giuseppe Portella, Luigi Atripaldi, Roberto Parrella, Rodolfo Conenna, Franco Maria Buonaguro, Ernesta Cavalcanti, Paolo Ascierto, Gerardo Botti, Attilio Bianchi

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The easy access to a quick diagnosis of coronavirus disease 2019 (COVID-19) is a key point to improve the management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to contain its spread. Up to now, laboratory real-time PCR is the standard of care, but requires a fully equipped laboratory and significant infrastructure. Consequently, new diagnostic tools are required. Methods: In the present work, the diagnostic accuracy of the point-of-care rapid test "bKIT Virus Finder COVID-19" (Hyris Ltd) is evaluated by a retrospective and a prospective analysis on SARS CoV-2 samples previously assessed with an FDA “authorized for the emergency use—EUA” reference method. Descriptive statistics were used for the present study. Results: Results obtained with the Hyris Kit are the same as that of standard laboratory-based real time PCR methods for all the analyzed samples. In addition, the Hyris Kit provides the test results in less than 2 h, a significantly shorter time compared to the reference methods, without the need of a fully equipped laboratory. Conclusions: To conclude, the Hyris kit represents a promising tool to improve the health surveillance and to increase the capacity of SARS-CoV-2 testing.

Original languageEnglish
Article number488
JournalJournal of Translational Medicine
Volume18
Issue number1
DOIs
Publication statusPublished - Dec 2020

Keywords

  • COVID-19
  • Health surveillance
  • Point-of-care rapid test
  • SARS-CoV-2

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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