Research Project
9050063
? DESCRIPTION (provided by applicant): Zansors is a biosensor company with several research and product areas to commercialize evidence-based healthcare solutions. This proposed research is aimed at achieving objective assessment of blood alcohol concentration (BAC) by offering a wearable real-time alcohol bio-sensing device based on a bendable and stretchable lab-on-a-patch platform invented by partner, George Washington University (GW). In 2010, despite education and awareness, 112 million individuals self-reported being impaired while driving their vehicle and 1.2 million individuals were arrested for driving under the influence of alcohol or narcotics. Responsible adults understand the risks of intoxication, but stil make the decision to drive while impaired, not knowing their actual BAC. Commercially available products are available, but can cost between >$150. Consumers typically have access to smartphones that are readily available and used at bars and restaurants so connecting a discrete sensing device through wireless communication to an application on a smartphone could deliver real-time notifications of their BAC. A discrete, bendable, stretchable lab-on-a-patch that integrates a hybrid of electrochemical alcohol sensors/electronics chip, microfluidic channels, and stretchable electrical interconnects that offer real-time monitoring of ethanol and metabolites in sweat will be a first-in-kind device that monitors objective BAC. Proof-of-principle data by GW was shown in Nature's Scientific Reports Jan. 2013 reporting a miniaturized lab-on-a-patch technology integrating semiconductor/CMOS sensors and electronics with microfluidics on a flexible substrate (PDMS) via liquid metal interconnects. Zansors has licensed the GW technology (US patent-pending 13/715,110) and a STTR grant will help establish feasibility for real-time monitoring of ethanol for BAC levels screening. Specific Aim 1: Design and fabricate a wearable, wireless lab- on-a-chip patch that measures sweat alcohol level near underarm. Design electrochemical fuel cell alcohol sensors; Design and assemble signal amplification electronics; and finish the microfluidic device design and fabrication. Specific Aim 2: Adapt and calibrate the algorithm to compute BAC from sweat data in real-time, and develop a mobile app to collect, process, analyze and store data from the device and communicate with a telemedicine and digital health cloud system. Specific Aim 3: Conduct an open-label clinical study with 20 participants to assess the preliminary engineering performance characteristics of the wireless biosensor.
