Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2
| Autor: | Laurent Kaiser, Francisco Perez, Angèle Gayet-Ageron, Manuel Schibler, Adriana Renzoni, Sabine Yerly, Erik Boehm, Marie Thérèse Ngo Nsoga |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Medicine (General) Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030106 microbiology Clinical Biochemistry Rapid detection Turnaround time 03 medical and health sciences Reference test R5-920 rapid diagnostic techniques Rapid diagnostic techniques Medicine POCT techniques ddc:613 ddc:616 ddc:618 SARS-CoV-2 business.industry Brief Report Gold standard (test) Virology 030104 developmental biology Real-time polymerase chain reaction business Sensitivity (electronics) |
| Zdroj: | Diagnostics Diagnostics, Vol 11, Iss 813, p 813 (2021) Diagnostics, Vol. 11, No 5 (2021) P. 813 |
| ISSN: | 2075-4418 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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