ArticleDiagnostics (Basel, Switzerland)2021
Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2.
Article in Diagnostics (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing (December 2023).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Guideline
- Pooled it
- A Portable Dual-Mode Microfluidic Device Integrating RT-qPCR and RT-LAMP for Rapid Nucleic Acid Detection in Point-of-Care Testing.Biosensors · 2026Article
- GenPad: A Highly Efficient Roadmap for the Development of a New Rapid, Highly Sensitive, and Portable Point-of-Care Testing System for Nucleic Acid Diagnostics in Japan.Diagnostics (Basel, Switzerland) · 2025Article
- Lyophilised Reverse Transcriptase and Polymerase for Point-of-Care Diagnostics of SARS-CoV-2.Microbial biotechnology · 2025Article
- Simultaneously ultrasensitive and differential detection of SARS-CoV-2, adenovirus and influenza a virus using multiplex fluorescence lateral flow immunoassay.Frontiers in immunology · 2025Article
- ƩS COVID-19 is a rapid high throughput and sensitive one-step quadruplex real-time RT-PCR assay.Scientific reports · 2024Article
- A Portable, Integrated, Sample-In Result-Out Nucleic Acid Diagnostic Device for Rapid and Sensitive Chikungunya Virus Detection.Micromachines · 2024Article
- Comparative Evaluation of a Standard M10 Assay with Xpert Xpress for the Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B Virus, and Respiratory Syncytial Virus.Diagnostics (Basel, Switzerland) · 2023Article
- The Diagnostic Performance of Various Clinical Specimens for the Detection of COVID-19: A Meta-Analysis of RT-PCR Studies.Diagnostics (Basel, Switzerland) · 2023Review
- Metallic nanoplatforms for COVID-19 diagnostics: versatile applications in the pandemic and post-pandemic era.Journal of nanobiotechnology · 2023Review
- Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System.Diagnostics (Basel, Switzerland) · 2023Article
- Review of HIV Self Testing Technologies and Promising Approaches for the Next Generation.Biosensors · 2023Review
- Miniaturized Real-Time PCR systems for SARS-CoV-2 detection at the Point-of-Care.Clinica chimica acta; international journal of clinical chemistry · 2022Review
- Performance comparison of two nucleic acid amplification systems for SARS-CoV-2 detection: A multi-center study.Journal of clinical laboratory analysis · 2022Article
- Principles and Applications of Loop-Mediated Isothermal Amplification to Point-of-Care Tests.Biosensors · 2022Review
- COVID Community-Engaged Testing in Alabama: Reaching Underserved Rural Populations Through Collaboration.American journal of public health · 2022Article
- Article
- FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances.Biosensors & bioelectronics: X · 2022Review
- STANDARD M10 SARS-CoV-2 Assay for Rapid Detection of SARS-CoV-2: Comparison of Four Real-Time PCR Assays.Diagnostics (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.