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J Transl Med ; 18(1): 488, 2020 12 21.
Artículo en Inglés | MEDLINE | ID: covidwho-992499

RESUMEN

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.


Asunto(s)
Prueba de Ácido Nucleico para COVID-19/métodos , COVID-19/diagnóstico , Sistemas de Atención de Punto , COVID-19/epidemiología , COVID-19/virología , Prueba de Ácido Nucleico para COVID-19/normas , Prueba de Ácido Nucleico para COVID-19/estadística & datos numéricos , Diagnóstico Precoz , Humanos , Italia/epidemiología , Límite de Detección , Pandemias , Sistemas de Atención de Punto/normas , Sistemas de Atención de Punto/estadística & datos numéricos , Estudios Prospectivos , Estándares de Referencia , Estudios Retrospectivos , SARS-CoV-2/genética , SARS-CoV-2/aislamiento & purificación , Sensibilidad y Especificidad , Investigación Biomédica Traslacional
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