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

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。COVID-19大流行凸显了呼吸道病毒常规诊断测试的根本缺陷。虽然实验室PCR（分子）测试具有金标准性能，但它们需要专业设备和复杂的物流，这意味着无法及时获得结果，以告知有效的治疗或隔离决策。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，错过了许多感染病例。随着COVID-19成为地方性疾病，以及流感和RSV的死灰复燃，仍然迫切需要改进呼吸道感染的诊断和治疗，以尽量减少爆发并保护弱势群体和医疗保健系统。无仪器分子诊断测试有望通过将实验室PCR的引人注目的临床益处与分散使用的一次性设备的灵活性相结合来解决这一挑战。虽然一次性设备中的分子检测技术可行性已得到证实，但第一代检测由于其固有的成本、环境足迹和获得结果的时间较长，无法满足更广泛的市场期望。我们的检测将设备设计的变革性简化与增强的分子技术相结合，从根本上降低了商品成本和环境影响。该测试将以超快速（<10 min）的多功能多重格式提供实验室PCR准确性，非常适合在任何使用环境中广泛部署。该测试的好处包括改善患者治疗，减少住院，更好地使用抗生素，减少死亡和显著降低整体医疗成本。未来在医院、全科医生和疗养院的使用将能够更有效地预防和控制感染，并支持大流行的准备工作。

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.