dc.creator | Apostolou T., Kyritsi M., Vontas A., Loizou K., Hadjilouka A., Speletas M., Mouchtouri V., Hadjichristodoulou C. | en |
dc.date.accessioned | 2023-01-31T07:32:40Z | |
dc.date.available | 2023-01-31T07:32:40Z | |
dc.date.issued | 2021 | |
dc.identifier | 10.1016/j.jviromet.2021.114166 | |
dc.identifier.issn | 01660934 | |
dc.identifier.uri | http://hdl.handle.net/11615/70741 | |
dc.description.abstract | Introduction: As 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 methods: All 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. Results: The 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. Conclusions: EMBIO 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. © 2021 Elsevier B.V. | en |
dc.language.iso | en | en |
dc.source | Journal of Virological Methods | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85104662597&doi=10.1016%2fj.jviromet.2021.114166&partnerID=40&md5=3c8c8a217edca7b7702b1c0d95db9df8 | |
dc.subject | Article | en |
dc.subject | bioassay | en |
dc.subject | Bioelectric Recognition Assay | en |
dc.subject | clinical evaluation | en |
dc.subject | controlled study | en |
dc.subject | coronavirus disease 2019 | en |
dc.subject | diagnostic test accuracy study | en |
dc.subject | human | en |
dc.subject | limit of detection | en |
dc.subject | major clinical study | en |
dc.subject | nasopharyngeal swab | en |
dc.subject | nonhuman | en |
dc.subject | oropharyngeal swab | en |
dc.subject | point of care testing | en |
dc.subject | predictive value | en |
dc.subject | prevalence | en |
dc.subject | real time polymerase chain reaction | en |
dc.subject | sensitivity and specificity | en |
dc.subject | Severe acute respiratory syndrome coronavirus 2 | en |
dc.subject | virus genome | en |
dc.subject | animal | en |
dc.subject | Chlorocebus aethiops | en |
dc.subject | diagnosis | en |
dc.subject | genetic procedures | en |
dc.subject | isolation and purification | en |
dc.subject | procedures | en |
dc.subject | Vero cell line | en |
dc.subject | Animals | en |
dc.subject | Biosensing Techniques | en |
dc.subject | Chlorocebus aethiops | en |
dc.subject | COVID-19 | en |
dc.subject | Humans | en |
dc.subject | Limit of Detection | en |
dc.subject | Point-of-Care Testing | en |
dc.subject | SARS-CoV-2 | en |
dc.subject | Sensitivity and Specificity | en |
dc.subject | Vero Cells | en |
dc.subject | Elsevier B.V. | en |
dc.title | Development and performance characteristics evaluation of a new Bioelectric Recognition Assay (BERA) method for rapid Sars-CoV-2 detection in clinical samples | en |
dc.type | journalArticle | en |