tetano
Editor, Senior Moderator
J Transl Med
. 2020 Dec 21;18(1):488.
doi: 10.1186/s12967-020-02651-y.
Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection
Leonardo Miscio[SUP] 1 [/SUP], Antonio Olivieri[SUP] 2 [/SUP], Francesco Labonia[SUP] 3 [/SUP], Gianfranco De Feo[SUP] 3 [/SUP], Paolo Chiodini[SUP] 4 [/SUP], Giuseppe Portella[SUP] 5 [/SUP], Luigi Atripaldi[SUP] 6 [/SUP], Roberto Parrella[SUP] 6 [/SUP], Rodolfo Conenna[SUP] 6 [/SUP], Franco Maria Buonaguro[SUP] 3 [/SUP], Ernesta Cavalcanti[SUP] 3 [/SUP], Paolo Ascierto[SUP] 3 [/SUP], Gerardo Botti[SUP] 3 [/SUP], Attilio Bianchi[SUP] 3 [/SUP]
Affiliations
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 [SUP]Ltd[/SUP]) 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.
Keywords: COVID-19; Health surveillance; Point-of-care rapid test; SARS-CoV-2.
. 2020 Dec 21;18(1):488.
doi: 10.1186/s12967-020-02651-y.
Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection
Leonardo Miscio[SUP] 1 [/SUP], Antonio Olivieri[SUP] 2 [/SUP], Francesco Labonia[SUP] 3 [/SUP], Gianfranco De Feo[SUP] 3 [/SUP], Paolo Chiodini[SUP] 4 [/SUP], Giuseppe Portella[SUP] 5 [/SUP], Luigi Atripaldi[SUP] 6 [/SUP], Roberto Parrella[SUP] 6 [/SUP], Rodolfo Conenna[SUP] 6 [/SUP], Franco Maria Buonaguro[SUP] 3 [/SUP], Ernesta Cavalcanti[SUP] 3 [/SUP], Paolo Ascierto[SUP] 3 [/SUP], Gerardo Botti[SUP] 3 [/SUP], Attilio Bianchi[SUP] 3 [/SUP]
Affiliations
- PMID: 33349261
- DOI: 10.1186/s12967-020-02651-y
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 [SUP]Ltd[/SUP]) 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.
Keywords: COVID-19; Health surveillance; Point-of-care rapid test; SARS-CoV-2.