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

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.

Comparative Performance of a New SARS-CoV-2 Rapid Detection System

“…Furthermore, we assessed the influence of swab transport medium on rRT-PCR performance, demonstrating that the limit of viral detection is highly affected by the use of saline solution storage medium compared to universal transport medium (UTM), as previously reported by other competitors ( 7 ). We showed that Hyris bKIT Virus Finder COVID-19 assays provide an efficiency similar to that of the comparator without risks of cross-reaction effects or false-negative results, supporting sensitivity parameters described during preliminary studies ( 10 , 11 ). Importantly, the simplicity and diagnostic quality standards of the bKIT Virus Finder COVID-19 make the Hyris system ideal for a SARS-CoV-2 rapid diagnosis.…”

Recent progress on rapid diagnosis of COVID-19 by point-of-care testing platforms

“…In addition, it benefits Low-income areas or communities that cannot provide POCT devices and extended testing [28] , [29] , [30] , [31] . The global pandemic has exposed apparent discrepancies in POCT techniques, and the significance of the development for preventing pandemics at their initial stage is highlighted [32] , [33] , [34] , [35] . In this review, we summarize related studies concerning POCT platforms.…”

“… 1 RT-PCR RNA (Nasopharyngeal swab) 140 RdRp, N 10 copies/ reaction 30 100% 99% Yes [94] RT-PCR RNA (Nasopharyngeal swab) N.A. RdRp, E, N 5 copies/µL 60 100% 100% Yes [35] dd-PCR RNA (Nasopharyngeal swab) 11 ORF1ab 2 copies/ reaction 300 91% 100% Yes [40] RT-LAMP RNA (Nasopharyngeal swab) 2 M/N 20 copies/μL 13 100% 100% Yes [42] RT-LAMP RNA (Nasopharyngeal swab) 1.8 N, S, RdRp 118.6 copies/ reaction 20 94% 90% Yes [45] RT-LAMP RNA (Throat swabs) 20 ORF1a/b,S, N 20 copies/ reaction 30 100% 100% Yes [43] RCA RNA (Human blood) 1 N 4.9 copies/µL 61 89.2% 100% Yes [54] RPA RNA (swabs) 1 RdRp, N, E 6.9 ± 5.3 copies/µL 30 92.6% 98.9% Yes …”

Innovative and Rapid Detection Methods for SARS-CoV-2 Infections: Recent Developments Worldwide

“…Hyris System TM provides more or less same results as RT-PCR method. It is a complete portable suite, which is versatile, fast, and reliable [30,31]. The main advantage of this test is it is fully automatic.…”