ABSTRACT
The spread of the new coronavirus SARS-CoV-2 has substantial social, health, and economic impacts. High viral load in the air in hospitals poses a risk to medical personnel. Cold atmospheric plasma (CAP) is a new technology based on the emission in the air of reactive species, neutral particles, UV radiation, and electromagnetic field. CAP has the potential as an antiviral agent. In this study, an 80-day clinical trial took place at Nicosia General Hospital to evaluate the application of CAP devices for lowering the viral load in the COVID rooms. A total of 284 indoor environment samples were tested by RT-PCR, for which 9 were positive (~3% Positive Rate). After analyzing the initial results, an ion emitter was paired with each patient, and the results showed that the method could eliminate the virus from the COVID wards up to 100%. The number of patients discharged from the hospital in the ionizer group was 4.8% higher than in the non-ionizer group, and 45% fewer patients in the ionizer group who remained in the rooms required oxygen support. The clinical trial shows evidence that composite CAP can decrease coronavirus spread in hospital environments and potentially prevent virus transmission.
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.