Innovation of a UK designed and manufactured self-test Covid-19 In Vitro Diagnostic Device to provide a long-term pandemic solution for the UK

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The UK Healthcare system faces an enormous challenge to facilitate the administration of a population-wide immunisation programme against COVID-19\. The widespread nature of the process of vaccination has meant that, until now, there has never been a pharmaco-economic justification that could bear the additional costs of vaccination using a self-administration device compared to a simple vial and needle syringe approach. The advent of the COVID-19 pandemic however, has brought about significant changes to our ways of working and social interaction that has impacted upon the way in which healthcare needs to be administered. Owen Mumford Ltd (OM) are working on the development of a Rapid Immunisation Delivery System (RIDS) to allow individuals to conduct self-immunisation in the comfort, safety and convenience of their own home. This approach would (i) significantly reduce the burden on the health services by removing the need for the practitioners and facilities to administer the injections; (ii) reduce the risk of viral exposure for the individual, particularly important for the at-risk population; (iii) offer additional time-saving cost benefit to the individual by removing the need to visit to a clinic. Moreover, the system offers itself as a platform for the potential to develop a broader UK vaccination strategy to enable individuals to self-inject other vaccines safely and with convenience. OM is a UK company with a global reach and has a long heritage and world class expertise in the design, manufacture and commericalisation of self-injection devices and diagnostics for various medical conditions. This proposal would allow OM to develop a simple to use, lateral-flow immunoassay (LFIA) diagnostic device suitable for home use, specific for antibodies to SARS-CoV-2 in human blood. Our vision is that the diagnostic would form the basis of a much broader Rapid Immunisation Delivery System (RIDS) in which an individual would (1) self-administer the vaccine using an autoinjector, (2) subsequently confirm the presence of antibodies by use of the home diagnostic test kit and (3) using device connectivity a digital confirmation would be created to validate vaccine delivery and antibody test outcome to provide the basis of an electronic certification of immunisation. This capability could be far-reaching and may provide a solution to multiple social and business challenges, such attending events with mass gatherings or air travel, in order to help the UK return to some level of normality.