Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection
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Journal of Translational Medicine Open Access
RESEARCH
Evaluation of the diagnostic accuracy of a new point‑of‑care rapid test for SARS‑CoV‑2 virus detection Leonardo Miscio1*, Antonio Olivieri2, Francesco Labonia1, Gianfranco De Feo1, Paolo Chiodini3, Giuseppe Portella4, Luigi Atripaldi5, Roberto Parrella5, Rodolfo Conenna5, Franco Maria Buonaguro1, Ernesta Cavalcanti1, Paolo Ascierto1, Gerardo Botti1† and Attilio Bianchi1†
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. Keywords: SARS-CoV-2, COVID-19, Point-of-care rapid test, Health surveillance Background The infection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the resulting coronavirus disease 2019 (COVID-19) present important diagnostic challenges [1, 2]. In particular, improved access to diagnostics is a key point to counteract the spread of the virus [3]. Different diagnostic strategies are now available to identify or exclude a current infection, identify people
*Correspondence: [email protected] † Gerardo Botti and Attilio Bianchi contributed equally to this work 1 Istituto Nazionale Tumori Di Napoli, IRCCS “G. Pascale”, Naples, Italy Full list of author information is available at the end of the article
in need of care escalation, or to test for past infection and immune response [4, 5]. Laboratory real-time (RT)-PCR represents the standard of care for the detection of the SARS-CoV-2 infection [6, 7], but this technique is time-consuming (up to 24 h for the result), not always available, and the technical requirements usually can only be met by centralized diagnostic laboratories. Point-of-care diagnostics tests to detect current SARSCoV-2 infection have the potential to allow an earlier detection of infection, compared to laboratory-based diagnostic methods, thus contributing to the reduction of household and community
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