Adhesive Patch for Disease Detection

Rotem Vishinkin, Department of Chemical Engineering, Technion - Israel Institute of Technology, Haifa, Israel
Hossam Haick, The Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion - Israel Institute of Technology, Haifa, Israel

Adhesive patch aims to research, develop, and validate a novel non-invasive wearable sensing patch for detection of infectious disease at point of care, specifically tuberculosis (TB), from skin, with an ability to serve as a monitoring and epidemic control tool. The patch will use a novel intelligent hybrid sensor array to detect disease-specific volatile organic compounds (VOCs) from the surface of the skin, enabling rapid and highly-accurate diagnosis using a small device. Tuberculosis (TB) is an infectious disease with not specific symptoms, thus leading to delayed diagnosis and further spread. In 2016, there were 10.4 million new TB cases, and 1.7 million deaths. About 95% of TB cases occur in developing countries. Currently available diagnostic methods have limitations in developing countries; therefore, a new diagnostic tool for TB diagnosis is required. The recent clinical study, conducted in two clinical sites South Africa and India, resulted in global classifier, based on skin sampling, discriminating between active pulmonary TB status and non-TB status with 92% sensitivity, 80.4% specificity and 84.9% accuracy. An advanced analysis based on the sensor array, with the same algorithm, resulted in discrimination between latent TB and extra-pulmonary TB from active pulmonary disease, among volunteers with negative HIV status and positive QFT status. GC-/MS analysis showed a unique pattern of VOCs which significantly discriminate between active and non-TB participants. These preliminary results present the first evidence for emission of TB VOCs from the skin. This adhesive patch aims to demonstrate a technological leap forward for wearable patches for TB detection that meets the requirements of the World Health Organization (WHO) for a triage test with 90% to 95% sensitivity and specificity of >70%.