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

该项目汇集了英国中小企业、Paragraf有限公司、曼彻斯特大学NIHR生物医学研究中心、利物浦大学感染研究所和纽卡斯尔大学NHS信托，共同开发和测试由石墨烯制成的新型体外诊断电子设备。Paragraf开发了一种独特的、开创性的石墨烯生产方法，这是第一次允许石墨烯在大范围内有效地合成，适用于电子设备。石墨烯生物传感器的研究已经多次证明了在不扩增的情况下对抗原、抗体、酶和DNA的高灵敏度和快速检测。它提供了独特的能力，将技术上分离的免疫学和分子IVD测试市场结合起来，价值400亿美元，并通过单一，快速，准确和紧凑的技术解决这些问题。这创造了一个巨大的商业机会。通过展示石墨烯的潜力，研究人员展示了在30秒内检测SARS-CoV-2，与需要45分钟的最佳商用仪器的分辨率相当。尽管对石墨烯生物传感器进行了大量研究，但目前还没有石墨烯诊断产品商业化。这在很大程度上是由于缺乏可重复的、具有成本效益的石墨烯制造工艺。Paragraf是唯一一家开发出可扩展生产高质量石墨烯方法的公司。下一步是证明该技术在医疗保健环境中的临床有效性，并根据临床医生和患者的访谈反馈以及护理路径分析来优化设备设计。

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.