Development and performance characteristics evaluation of a new Bioelectric Recognition Assay (BERA) method for rapid Sars-CoV-2 detection in clinical samples

Apostolou, Theofylaktos; Kyritsi, Maria; Vontas, Alexandros; Loizou, Konstantinos; Hadjilouka, Agni; Speletas, Mathaios; Mouchtouri, Varvara; Hadjichristodoulou, Christos

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.