A CONTROLLED CLINICAL STUDY TO EVALUATE A PROPRIETARY NON-INVASIVE\nSMARTPHONE BASED DIGITAL BIOMARKER TOOL LYFAS® IN ENABLING EARLY\nDETECTION 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\nincreasing number of individuals infected with COVID-19, there is a growing need for easy, dependable, accurate, scalable, and cost-effective\ntools. These tools should serve the purpose of population screening/surveillance, diagnosis, and prognosis. Unlike the other pandemics in the past,\nthe current viral infection presents itself with long incubation period up to 14days. This situation is challenging because it results in an extremely\nhigh proportion of asymptomatic individuals (up to 80% and more). These individuals in turn contribute to high risk of transmission among the\nvulnerable population with coexisting diseases and the aged. Currently, the real time PCR test and serology is being largely employed only in\nsymptomatic individuals. Therefore, there is a need for a dependable additional test to identify the asymptomatic individuals, to qualify them for\nthe con\uf001rmatory rtPCR and/or serology tests.\nTo meet these the above requirement, we decided to repurpose and test our proprietary non-invasive smartphone-based health screening mobile\napplication Lyfas. The validated parameters captured from Lyfas were found to be inherent indicators of several cardiorespiratory, cardiovascular,\nautonomic nervous system, hematology and biochemistry anomalies. Apparently, these anomalies were also found and reported as early indicators\nof COVID-19 infection. Therefore, by means of rationale selection of these parameters, we derived a unique LYFAS_COVID_SCORE to enable\ndetection and prioritize con\uf001rmatory testing for asymptomatic individuals.\nA controlled clinical study was conducted in 25(n=25) subjects to prove the hypothesis and establish the difference in LYFAS_COVID_SCORE\nbetween an infected and non-infected group of individuals. The LYFAS_COVID_SCORE derived out of this clinical study was found to be\ndifferent between the two groups. The positive infected test group had a signi\uf001cantly high(p=.00012) median score of 19.8(range 9.9 to 22.1)\ncompared to 6.9(range 2.2 to 7.8) that of the healthy uninfected control group. The accuracy, sensitivity and the speci\uf001city of the study was found to\nbe 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\uf001cation, screening,\nand surveillance of asymptomatic individuals. The \uf001ndings from the study deserves to be extended to a large population con\uf001rmatory clinical study\nto add proof and value to the tool.