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

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

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.