Rapid Point-of-Care Diagnostic Device for COVID-19

COVID-19 快速护理点诊断设备

• 批准号: 54731
• 金额: $ 13.94万
• 依托单位: GB ELECTRONICS (UK) LIMITED
• 依托单位国家: 英国
• 项目类别: Feasibility Studies
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=54731
• 关键词: Rapid; Point; Care; Diagnostic; Device

GB Electronics (UK) ltd., (GBE), a design-led manufacturing UK based SME is working with Brunel University London (BUL) to help them bring to market their low-cost and portable smart molecular diagnostic platform for the detection of SARS-CoV-2 (Covid-19).Prior to the Coronavirus Pandemic, an early stage version of the product was being developed by a research team led by BUL in collaboration with the University of Lancaster and the University of Surrey and intended to be used for detecting viral pathogens in poultry, funded by the Biotechnology and Biological Science Research Council (BBSRC). The research team established that with some modification their product could use a Loop Mediated Isothermal Amplification (LAMP) assay to detect COVID-19 directly from a patient sample (nasal or throat swabs) within 30 minutes. Another strength of their design was that it analysed six samples per cycle and was being specifically developed for low-cost deployment in the developing world.A set of eight early stage products are currently undergoing laboratory and clinical validation studies at NHS Laboratories. The results of which will be used to further optimise the diagnostic algorithm and the physical design of the product.GBE will then assist with the manufacture of a batch of beta products, which will be a design iteration based on the initial trial units. This increases the amount of clinical trial data available and will provide essential feedback on the functionality of the product.The beta units will then undergo a significant 'cost-down' design for manufacture stage in order to prepare for mass production. This stage will involve refinement of the hardware, firmware and mechanical design plus development of a robust communications protocol. It will be manufactured in-house at GBE's Sussex based factory.All work will be carried out in conjunction with Brunel and their team in order to optimise the efficacy of the product. Whilst gathering additional functional data we will also prepare detailed market analysis to maximise the global and industrial potential of the product. With a keen focus on the needs of the developing world, where product cost is vital.GBE has over 30 years' experience of embedded product development and manufacturing. This includes a very successful track record within the healthcare market plus experience of working with innovative product launches and solutions.Development of the product, now called the Virus Hunter 6 ( VH-6), has been at an accelerated pace. This has been along with the exponentially growing public need for a rapid point-of-care Covid-19 diagnostic device. We had the opportunity to accelerate development and allocate resources to this project, however this had meant the grant was quickly used and GBE has also funded additional work over the last 6 months. This was also in part due to the cutting edge aspects of this project, plus the constantly changing requirements: this Pandemic has seen the world enter very challenging times and all efforts are focused on dealing with this ‘new normal’. The design path has had to be extremely flexible as both the science (of the virus and its propagation) evolve along with the national and international response to it are changing on an almost weekly basis. Four key new deliverables have been identified which will have a significant impact in the rapid development and deployment of this Covid-19 detector. These are to be carried out over the next three months and will also include a real-life controlled trial of 1,500 tests at University of Surrey (for current students and employees) vs a gold standard PCR. Success will lead to expanding this to all of Surrey and Brunel University London (over 30,000 students and employees). Data gathered will be instrumental to rapid deployment of the product - enhancing its functionality and providing additional data for new scientific publications. Alongside this, we have an opportunity for smaller real-life controlled trials.

GB Electronics (UK) ltd. （GBE）是一家以设计为主导的英国制造中小企业，目前正与伦敦布鲁内尔大学（BUL）合作，帮助他们将低成本、便携式的智能分子诊断平台推向市场，用于检测SARS-CoV-2 （Covid-19）。在冠状病毒大流行之前，由喀布尔大学领导的一个研究小组正在与兰开斯特大学和萨里大学合作开发该产品的早期版本，旨在用于检测家禽中的病毒病原体，由生物技术和生物科学研究委员会（BBSRC）资助。研究小组确定，经过一些修改，他们的产品可以使用环介导等温扩增（LAMP）法在30分钟内直接从患者样本（鼻或咽拭子）中检测出COVID-19。他们设计的另一个优势是，它每周期分析6个样本，并且是专门为发展中国家的低成本部署而开发的。一组8个早期阶段的产品目前正在NHS实验室进行实验室和临床验证研究。其结果将用于进一步优化诊断算法和产品的物理设计。然后，GBE将协助制造一批测试产品，这将是基于初始试验单元的设计迭代。这增加了可用的临床试验数据量，并将提供有关产品功能的基本反馈。然后，测试单元将经历一个重要的“降低成本”的制造设计阶段，以便为大规模生产做准备。这一阶段将涉及硬件、固件和机械设计的细化以及健壮通信协议的开发。它将在GBE位于苏塞克斯的工厂内部制造。所有工作都将与Brunel和他们的团队一起进行，以优化产品的功效。在收集其他功能数据的同时，我们还将准备详细的市场分析，以最大限度地发挥产品的全球和工业潜力。对产品成本至关重要的发展中国家的需求有着敏锐的关注。GBE拥有超过30年的嵌入式产品开发和制造经验。这包括在医疗保健市场中非常成功的记录，以及与创新产品发布和解决方案合作的经验。该产品现在被称为病毒猎手6 (VH-6)，其开发速度一直在加快。与此同时，公众对Covid-19即时诊断设备的需求呈指数级增长。我们本有机会加速开发并为该项目分配资源，但这意味着赠款很快就被使用了，GBE还在过去6个月里资助了额外的工作。这在一定程度上也是由于这个项目的尖端方面，加上不断变化的需求：这次大流行使世界进入了非常具有挑战性的时期，所有的努力都集中在应对这一“新常态”上。设计路径必须非常灵活，因为（关于病毒及其传播的）科学随着国家和国际应对措施的变化而不断发展，几乎每周都在变化。已经确定了四项关键的新成果，这将对快速开发和部署这种Covid-19检测器产生重大影响。这些将在接下来的三个月里进行，还将包括在萨里大学（针对在校生和员工）进行的1500项现实对照试验，与金标准PCR相比。成功将导致扩展到整个萨里和布鲁内尔大学伦敦（超过30,000名学生和员工）。收集的数据将有助于产品的快速部署——增强其功能并为新的科学出版物提供额外的数据。除此之外，我们还有机会进行小规模的现实对照试验。