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.
Keywords: Bioelectric Recognition Assay (BERA); Cell-based biosensor technology; Point-of-care (POC) test; Sars-CoV-2.
【저자키워드】 SARS-CoV-2, Bioelectric Recognition Assay (BERA), Cell-based biosensor technology, Point-of-care (POC) test, 【초록키워드】 COVID-19, SARS-COV-2 infection, COVID-19 pandemic, POC, point of care, Genome, Diagnosis, RT-PCR, Predictive value, Prevalence, clinical samples, SARS-CoV-2 detection, sensitivity, specificity, Positive predictive value, Characteristics, limit of detection, Isolation, Community, Cyprus, second wave, Concentration, Negative predictive value, Ct values, prevalence rates, Recognition, confirmed cases, transmissions, material, positive, negative, approach, value, negative sample, clinical sample, tested, performed, detect, develop, evaluate, subsequent, were used, to define, reduce, recorded, NPV, PPV, 【제목키워드】 Characteristics, development, Recognition, clinical sample,