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

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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.