Scientific article
Open access

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

Published inDiagnostics, vol. 11, no. 5, 813
Publication date2021

Extended community testing constitutes one of the main strategic pillars in controlling theCOVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome onnasopharyngeal swab samples is currently the reference test. While displaying excellent analyticalsensitivity and specificity, this test is costly, often requires a substantial turnaround time, and, moreimportantly, 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, anddecentralized SARS-CoV-2 testing. The main drawback of these tests is the reduced sensitivity whenRT-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, comparedto the Cobas 6800 RT-qPCR assay (Roche), this RT-PCR POC technology detects SARS-CoV-2 RNAwith 95% sensitivity (95%CI = 86.3–99%) and 100% specificity (95% CI = 80.5–100%). For sampleswith cycle-threshold values below 31, we observed 100% sensitivity (95% CI = 66.4–100%). Whileshowing an analytical sensitivity slightly below that of a standard RT-qPCR system, the evaluatedVisby RT-PCR POC device may prove to be an interesting diagnostic alternative in the COVID-19pandemic, potentially combining the practical advantages of rapid antigen tests and the robustanalytical performances of nucleic acid detection systems.

  • SARS-CoV-2
  • Rapid diagnostic techniques
  • POCT techniques
Citation (ISO format)
RENZONI, Adriana Maria et al. Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2. In: Diagnostics, 2021, vol. 11, n° 5, p. 813. doi: 10.3390/diagnostics11050813
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ISSN of the journal2075-4418

Technical informations

Creation05/05/2021 11:10:00 AM
First validation05/05/2021 11:10:00 AM
Update time03/16/2023 12:33:09 AM
Status update03/16/2023 12:33:08 AM
Last indexation02/12/2024 12:05:21 PM
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