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

GB电子（英国）有限公司，(GBE)，一家以设计为主导的制造业英国中小企业正在与布鲁内尔大学伦敦（BUL）合作，帮助他们将其低成本和便携式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，该产品的早期版本由BUL领导的研究小组与兰开斯特大学和萨里大学合作开发由生物技术和生物科学研究理事会（BBSRC）资助，旨在用于检测家禽中的病毒病原体。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）检测，在30分钟内直接从患者样本（鼻或咽拭子）中检测COVID-19。他们设计的另一个优势是，它每个周期分析6个样品，并且专门为发展中国家的低成本部署而开发。一套8个早期产品目前正在NHS实验室进行实验室和临床验证研究。测试结果将用于进一步优化诊断算法和产品的物理设计。GBE将协助生产一批测试产品，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，并将为产品的功能提供重要的反馈。然后，测试单元将在制造阶段进行显著的“成本降低”设计，为大规模生产做准备。这一阶段将涉及改进硬件、固件和机械设计，以及开发一个强大的通信协议。它将在GBE的苏塞克斯工厂内部生产。所有的工作都将与Brunel及其团队一起进行，以优化产品的功效。在收集更多功能数据的同时，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行业潜力。GBE专注于发展中国家的需求，产品成本至关重要。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上非常成功的业绩记录，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人6（VH-6），其开发速度一直在加快。这与公众对快速护理点COVID-19诊断设备的需求呈指数增长沿着。我们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，GBE在过去6个月还资助了其他工作。这也部分归因于该项目的前沿方面，加上不断变化的要求：这场大流行病使世界进入了非常具有挑战性的时期，所有努力都集中在应对这种“新常态”上。设计路径必须非常灵活，因为科学（病毒及其传播）随着国家和国际对它的反应沿着发展，几乎每周都在变化。已确定了四个关键的新交付成果，这些成果将对新型冠状病毒检测器的快速开发和部署产生重大影响。这些将在未来三个月内进行，还将包括在萨里大学进行的1,500项测试的真实对照试验（针对当前学生和员工）与金标准PCR。成功将导致扩大到所有萨里和布鲁内尔大学伦敦（超过30,000名学生和员工）。所收集的数据将有助于该产品的快速部署-增强其功能并为新的科学出版物提供更多数据。除此之外，我们还有机会进行更小规模的实际对照试验。

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.