학술논문
Development and performance characteristics evaluation of a new Bioelectric Recognition Assay (BERA) method for rapid Sars-CoV-2 detection in clinical samples.
Document Type
Academic Journal
Author
Apostolou T; EMBIO Diagnostics Ltd, Athalassas Ave 8, Strovolos, 2018 Nicosia, Cyprus.; Kyritsi M; Laboratory of Hygiene and Epidemiology, University of Thessaly, School of Health Sciences, Faculty of Medicine, Papakyriazi 22, Larissa, Greece.; Vontas A; Laboratory of Hygiene and Epidemiology, University of Thessaly, School of Health Sciences, Faculty of Medicine, Papakyriazi 22, Larissa, Greece.; Loizou K; EMBIO Diagnostics Ltd, Athalassas Ave 8, Strovolos, 2018 Nicosia, Cyprus.; Hadjilouka A; EMBIO Diagnostics Ltd, Athalassas Ave 8, Strovolos, 2018 Nicosia, Cyprus.; Speletas M; Department of Immunology & Histocompatibility, School of Health Sciences, Faculty of Medicine, University of Thessaly, Panepistimiou 3, GR-41500 Biopolis, Larissa, Greece.; Mouchtouri V; Laboratory of Hygiene and Epidemiology, University of Thessaly, School of Health Sciences, Faculty of Medicine, Papakyriazi 22, Larissa, Greece.; Hadjichristodoulou C; Laboratory of Hygiene and Epidemiology, University of Thessaly, School of Health Sciences, Faculty of Medicine, Papakyriazi 22, Larissa, Greece. Electronic address: xhatzi@uth.gr.
Source
Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 8005839 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0984 (Electronic) Linking ISSN: 01660934 NLM ISO Abbreviation: J Virol Methods Subsets: MEDLINE
Subject
Language
English
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.
(Copyright © 2021 Elsevier B.V. All rights reserved.)
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.
(Copyright © 2021 Elsevier B.V. All rights reserved.)