Novel point of care test technology development: Initial focus - differentiating between bacterial and viral infections to

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This project brings together a UK SME, Paragraf Ltd., the University of Manchester NIHR Biomedical Research Centre, the University of Liverpool Institute of Infection and the University of Newcastle NHS trust to develop and test novel in-vitro diagnostic electronic devices made from graphene. Paragraf has developed a unique and groundbreaking production method for graphene which, for the first time, allows graphene to be synthesised cos-effectively in large areas, suitable for electronic devices.Research on graphene biosensors has repeatedly demonstrated highly sensitive and rapid detection of antigens, antibodies, enzymes and DNA without amplification. It offers the unique ability to combine the technically segregated immunological and molecular IVD test markets, valued at \>$40 billion, and address them with a single, rapid, accurate and compact technology. This creates a substantial commercial opportunity.By way of showing graphene's potential, researchers have demonstrated SARS-CoV-2 detection in 30 seconds, comparable to resolution of the best commercial instrument that takes 45 minutes. Despite substantive graphene biosensor research, no graphene diagnostic products are commercially available. This is largely due to the lack of reproducible, cost-effective graphene manufacturing process. Paragraf is the only company to have developed scalable methods to manufacture high-quality graphene.The next step is to demonstrate the clinical validity of the technology in healthcare settings and to optimise the device designs based on interview feedback from clinicians and patients, and care pathway analysis.