Preparing for the Next Pandemic - a Rapid, Low-Cost, Instrument-Free Molecular Diagnostic Test for Respiratory Pathogens

为下一次大流行做好准备——一种快速、低成本、无需仪器的呼吸道病原体分子诊断测试

• 批准号: 10076746
• 金额: $ 44.5万
• 依托单位: FUSE DIAGNOSTICS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10076746
• 关键词: Preparing; Next; Pandemic; Rapid; Low

In this project we are developing a next-generation instrument-free molecular diagnostic test for seasonal respiratory viruses (Flu, COVID-19 and RSV) with potential to transform management of the next pandemic.The COVID-19 pandemic highlighted the fundamental flaws with conventional diagnostic tests for respiratory viruses. Whilst laboratory PCR (molecular) tests exhibit gold-standard performance they require specialist equipment and complex logistics meaning that results are not available in time to inform effective treatment or isolation decisions. In contrast, rapid lateral flow tests are cheap and convenient but miss many cases of infection due to their inherant low sensitivity and variable performance.With COVID-19 becoming endemic and a resurgence in Flu and RSV, there remains a critical need for improved diagnosis and treatment of respiratory infections to minimise outbreaks and protect vulnerable groups and the healthcare system. Instrument-free molecular diagnostic tests promise to address this challenge by combining the compelling clinical benefits of laboratory PCR with the flexibility of a disposable device for decentralised use. Whilst the technical feasibility of molecular testing in a disposable device has been demonstrated, first-generation tests do not meet wider market expectations, due to their inherent cost, environmental footprint and slow time-to-result.Our test combines a transformative simplification in device design with enhanced molecular technology, to realise a fundamental reducion in cost-of-goods and environmental impact. The test will deliver laboratory PCR accuracy in an ultra-rapid (<10 min) versatile multiplex format, ideally suited to widespread deployment in any use setting.The benefits of the test include improved treatment of patients, fewer hospitalisations, better use of antibiotics, fewer deaths and significantly lower overall healthcare costs. Future use at hospitals, GPs and nursing homes will enable more effective prevention and infection control and support pandemic preparedness.

在这个项目中，我们正在开发下一代季节性呼吸道病毒（流感、COVID-19和RSV）的无仪器分子诊断测试，有可能改变下一次大流行的管理方式。2019冠状病毒病大流行凸显了传统呼吸道病毒诊断检测的根本缺陷。虽然实验室PCR（分子）检测表现出金标准的性能，但它们需要专业设备和复杂的物流，这意味着不能及时获得结果，从而为有效的治疗或隔离决策提供信息。相比之下，快速侧流检测便宜且方便，但由于其固有的低灵敏度和可变性能而错过了许多感染病例。随着COVID-19成为地方性流行病，流感和RSV卷土重来，仍然迫切需要改进呼吸道感染的诊断和治疗，以尽量减少疫情并保护弱势群体和卫生保健系统。无仪器分子诊断测试通过将实验室PCR的引人注目的临床益处与一次性设备分散使用的灵活性相结合，有望解决这一挑战。虽然一次性装置中分子检测的技术可行性已经得到证明，但由于其固有的成本、环境足迹和取得结果的时间较慢，第一代测试无法满足更广泛的市场预期。我们的测试将设备设计的变革性简化与增强的分子技术相结合，从根本上降低了产品成本和环境影响。该测试将以超快速（<10分钟）多功能多路格式提供实验室PCR准确性，非常适合在任何使用环境中广泛部署。这种检测的好处包括改善病人的治疗，减少住院治疗，更好地使用抗生素，减少死亡，并显著降低总体医疗成本。未来在医院、全科医生和疗养院使用，将能够更有效地预防和控制感染，并支持大流行防范。