A Controlled Clinical Study to Evaluate a Proprietary Non-Invasive Smartphone Based Digital Biomarker Tool Lyfas® in Enabling Early Detection of Covid-19 Infection Among Asymptomatic Individuals

Abstract

Coronavirus disease 2019 (COVID-19), is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With the increasing number of individuals infected with COVID-19, there is a growing need for easy, dependable, accurate, scalable, and cost-effective tools. These tools should serve the purpose of population screening/surveillance, diagnosis, and prognosis. Unlike the other pandemics in the past, the current viral infection presents itself with long incubation period up to 14days. This situation is challenging because it results in an extremely high proportion of asymptomatic individuals (up to 80% and more). These individuals in turn contribute to high risk of transmission among the vulnerable population with coexisting diseases and the aged. Currently, the real time PCR test and serology is being largely employed only in symptomatic individuals. Therefore, there is a need for a dependable additional test to identify the asymptomatic individuals, to qualify them for the conrmatory rtPCR and/or serology tests. To meet these the above requirement, we decided to repurpose and test our proprietary non-invasive smartphone-based health screening mobile application Lyfas. The validated parameters captured from Lyfas were found to be inherent indicators of several cardiorespiratory, cardiovascular, autonomic nervous system, hematology and biochemistry anomalies. Apparently, these anomalies were also found and reported as early indicators of COVID-19 infection. Therefore, by means of rationale selection of these parameters, we derived a unique LYFAS_COVID_SCORE to enable detection and prioritize conrmatory testing for asymptomatic individuals. A controlled clinical study was conducted in 25(n=25) subjects to prove the hypothesis and establish the difference in LYFAS_COVID_SCORE between an infected and non-infected group of individuals. The LYFAS_COVID_SCORE derived out of this clinical study was found to be different between the two groups. The positive infected test group had a signicantly high(p=.00012) median score of 19.8(range 9.9 to 22.1) compared to 6.9(range 2.2 to 7.8) that of the healthy uninfected control group. The accuracy, sensitivity and the specicity of the study was found to be 92%, 93.2% and 90% respectively. The result of this study is therefore an evidence to use Lyfas as a potential tool in the identication, screening, and surveillance of asymptomatic individuals. The ndings from the study deserves to be extended to a large population conrmatory clinical study to add proof and value to the tool.