Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2

Abstract

Extended community testing constitutes one of the main strategic pillars in controlling the COVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome on nasopharyngeal swab samples is currently the reference test. While displaying excellent analytical sensitivity and specificity, this test is costly, often requires a substantial turnaround time, and, more importantly, is subject to reagent and other material shortages. To complement this technology, rapid antigen tests have been developed and made available worldwide, allowing cheap, quick, and decentralized SARS-CoV-2 testing. The main drawback of these tests is the reduced sensitivity when RT-PCR is the gold standard. In this study, we evaluate Visby an innovative, portable, easy-to-use RT-PCR point-of-care (POC) diagnostic device. Our retrospective analysis shows that overall, compared to the Cobas 6800 RT-qPCR assay (Roche), this RT-PCR POC technology detects SARS-CoV-2 RNA with 95% sensitivity (95%CI = 86.3–99%) and 100% specificity (95% CI = 80.5–100%). For samples with cycle-threshold values below 31, we observed 100% sensitivity (95% CI = 66.4–100%). While showing an analytical sensitivity slightly below that of a standard RT-qPCR system, the evaluated Visby RT-PCR POC device may prove to be an interesting diagnostic alternative in the COVID-19 pandemic, potentially combining the practical advantages of rapid antigen tests and the robust analytical performances of nucleic acid detection systems.

Feasibility of Rapid Diagnostic Technology for SARS-CoV-2 Virus Using a Trace Amount of Saliva

“…Recently, POCT is a test concept that has been attracting attention, as several small devices that can perform qPCR in a short time have been developed, which can overcome many of the aforementioned problems. Attempts to apply these as SARS-CoV-2 detection devices are being reported [17]. The introduction of POCT equipment is cost-effective, provides detection capabilities that are comparable to conventional qPCR equipment, and eliminates the need for large laboratories and equipment.…”

Diagnostic assay and technology advancement for detecting SARS-CoV-2 infections causing the COVID-19 pandemic

“…Despite these drawbacks, RT-PCR is still the gold standard for verifying COVID-19 diagnosis. Since the outbreak of the pandemic, numerous efforts have been made to produce handheld PCR devices [56,57]. CovidNudge, a lab-on-a-chip device, can conduct sample preparation and real-time RT-PCR in remote locations.…”

SARS-CoV-2 detection using reverse transcription strand invasion based amplification and a portable compact size instrument

“…Heating and cooling require specialized equipment and so far, the most common PCR instruments have been too big and heavy to handle outside the laboratory. Recently, the CovidNudge portable RT-PCR platform 27 and the single-use RT-PCR device from Visby medical 26 were developed which opens the possibility to perform the gold standard RT-PCR outside the laboratory. The Egoo instrument uses similar fluorescence optics as a PCR instrument and as such we observe a similar performance of the SARS-CoV-2 RT-SIBA assay in the two instruments with an analytical sensitivity of 25 viral RNA copies per reaction.…”

“…Simplified RT-PCR workflows has been developed using nucleic acid (NA) extraction free methods such as direct lysis or heat 5 – 9 or alternative NAAT tests such as loop-mediated isothermal amplification (RT-LAMP) 10 – 17 , CRISPR-Cas12 and CRISPR-Cas13a based systems 18 , 19 , recombinase polymerase amplification (RT-RPA) 20 – 22 , and nicking-endonuclease amplification reactions (RT-NEAR) 23 , 24 which can reduce the overall reaction time to approximately 20–30 min. Some of these NAAT tests has been developed to be performed outside specialized laboratories such as the Cue COVID-2 test 25 , the Visby medical SARS-CoV-2 test 26 and the DNAnudge Covid-19 test 27 .…”