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

英国医疗保健系统面临着巨大的挑战，以促进针对COVID-19的全民免疫接种计划的管理。疫苗接种过程的广泛性意味着，到目前为止，与简单的小瓶和针头注射器方法相比，使用自我接种装置接种疫苗的额外成本从未有过药物经济学依据。然而，COVID-19疫情的到来为我们的工作及社交方式带来重大改变，影响了医疗管理的方式。Owen Mumford Ltd（OM）正在开发一种快速免疫接种系统（RIDS），使个人能够在自己家中舒适、安全和方便地进行自我免疫接种。这种方法将（i）通过消除对从业人员和设施进行注射的需要而显著减轻卫生服务的负担;（ii）降低个体的病毒暴露风险，这对高危人群尤其重要;（iii）通过消除对去诊所的需要而为个体提供额外的节省时间的成本效益。此外，该系统为开发更广泛的英国疫苗接种策略提供了一个平台，使个人能够安全方便地自行注射其他疫苗。OM是一家全球性的英国公司，在设计、制造和自动注射设备以及各种医疗条件的诊断方面拥有悠久的历史和世界一流的专业知识。该提案将使OM能够开发一种简单易用的、适用于家庭使用的侧流免疫测定（LFIA）诊断设备，对人类血液中的SARS-CoV-2抗体具有特异性。我们的愿景是，诊断将形成更广泛的快速免疫递送系统（RIDS）的基础，其中个人将（1）使用自动注射器自我接种疫苗，（2）随后通过使用家庭诊断测试试剂盒确认抗体的存在，以及（3）使用设备连接，将创建数字确认以验证疫苗递送和抗体测试结果，免疫接种。这种能力可能影响深远，并可能为多种社会和商业挑战提供解决方案，例如参加大型集会或航空旅行，以帮助英国恢复某种程度的正常状态。

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.