ArticleJournal of virological methods2021
Development and performance characteristics evaluation of a new Bioelectric Recognition Assay (BERA) method for rapid Sars-CoV-2 detection in clinical samples.
Article in Journal of virological methods, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.
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Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis.PLoS medicine · 2021Pooled it
- Electronic and electrochemical viral detection for point-of-care use: A systematic review.PloS one · 2021Pooled it
- A Proof-of-Concept Study on Bioelectric-Based Biosensing for Prostate-Specific Antigen Detection in Serum Samples.Biosensors · 2025Article
- A Systematic Review and Meta-Analysis Comparing the Diagnostic Accuracy Tests of COVID-19.Diagnostics (Basel, Switzerland) · 2023Review
- Article
- Clinical Application of the Novel Cell-Based Biosensor for the Ultra-Rapid Detection of the SARS-CoV-2 S1 Spike Protein Antigen: A Practical Approach.Biosensors · 2021Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAs the second wave of COVID-19 pandemic is in progress the development of fast and cost-effective approaches for diagnosis is essential. The aim of the present study was to develop and evaluate the performance characteristics of a new Bioelectric Recognition Assay (BERA) regarding Sars-CoV-2 detection in clinical samples and its potential to be used as a point of care test. MATERIALS AND
methodsAll tests were performed using a custom portable hardware device developed by EMBIO DIAGNOSTICS (EMBIO DIAGNOSTICS Ltd, Cyprus). 110 positive and 136 negative samples tested by RT-PCR were used in order to define the lower limit of detection (L.O.D.) of the system, as well as the sensitivity and the specificity of the method.
resultsThe system was able to detect a viral concentration of 4 genome copies/μL. The method displayed total sensitivity of 92.7 % (95 %CI: 86.2-96.8) and 97.8 % specificity (95 %CI: 93.7-99.5). When samples were grouped according to the recorded Ct values the BERA biosensor displayed 100.00 % sensitivity (95 %CI: 84.6-100.0) for Ct values <20-30. For the aforementioned Ct values the Positive Predictive Value (PPV) of the method was estimated at 31.4 % for COVID-19 prevalence of 1% and at 70.5 % for 5% prevalence. At the same time the Negative Predictive Value (NPV) of the BERA biosensor was at 100.0 % for both prevalence rates.
conclusionsEMBIO DIAGNOSTICS BERA for the detection of SARS-CoV-2 infection has the potential to allow rapid and cost-effective detection and subsequent isolation of confirmed cases, and therefore reduce household and community transmissions.
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