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

J Transl Med. 2020 Dec 21;18(1):488. 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 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: COVID-19; Health surveillance; Point-of-care rapid test; SARS-CoV-2.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 / epidemiology
  • COVID-19 / virology
  • COVID-19 Nucleic Acid Testing / methods*
  • COVID-19 Nucleic Acid Testing / standards
  • COVID-19 Nucleic Acid Testing / statistics & numerical data
  • Early Diagnosis
  • Humans
  • Italy / epidemiology
  • Limit of Detection
  • Pandemics
  • Point-of-Care Systems* / standards
  • Point-of-Care Systems* / statistics & numerical data
  • Prospective Studies
  • Reference Standards
  • Retrospective Studies
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / isolation & purification
  • Sensitivity and Specificity
  • Translational Research, Biomedical