Crimean-Congo haemorrhagic fever (CCHF) is a World Health Organisation (WHO)-listed priority disease due to its high mortality and lack of vaccines and effective treatment and diagnostics. Patients with CCHF have a high mortality and there is only one antiviral used that may only be effective if given early in disease. However, the current turnaround of test results for CCHF diagnosis is slow with a 2-5-day delay causing reduced treatment efficacy and poor patient recovery. The development of rapid diagnostic tests (RDTs) for rapid diagnosis of CCHF has been identified as a priority by the WHO. This proposal seeks to address this need and the Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT prototype to diagnose CCHF with a sensitivity and specificity that fulfils the recommendations from WHO for RDTs. LSTM in collaboration with GADx will optimise the RDT to refine sensitivity and specificity within an ISO-accredited environment. GADx will perform up-scale of manufacturing techniques including bulk conjugations and use quality control systems within their Quality Management System to ensure that the RDT preserves its original performance between batches and when manufactured at commercial volumes. We will do a market scoping exercise to identify the customers and pull through mechanisms to market for this important RDT. We will design-lock the product with all the kit components for evaluation. Firstly, we will perform analytical evaluations across all CCHF viral lineages with UK Health Security Agency (UKHSA) and following this we will evaluate the RDT in banked samples at the Ministry of Health (MoH) in Turkey and the Centers for Disease Control and Prevention (CDC) in Iraq. Also, in collaboration with the MoH, LSTM will set up clinical trials for diagnostic evaluation of the RDT among 492 patients attending secondary health clinics in CCHF hyperendemic regions in Turkey. Data from these trials will be used for preparation of regulatory submission under UKCA marking.

Amid an ever-increasing government and consumer interest in reducing plastic waste, the estimated global use of 15 million tonnes of plastic in the healthcare sector presents some unique challenges. While in the UK, the NHS already has plans to reduce unnecessary plastic waste as part of 'Delivering a Net Zero NHS', new practices and technologies will be required to achieve that target. Among the plastics used in the healthcare sector, the waste associated with plastic used in medical testing within both clinical settings and beyond, represents a large volume of plastic that presents unique opportunities for circularisation. This waste is currently mostly disposed of by incineration or disposal into landfill or, worse, directly in the environment, thus leading to environmental pollution. Circularisation of these plastics would result in significant reduction in plastic wastes, as well as providing large cost savings to organisations, such as the NHS. Medical testing plastics can be typically characterised into two very different ways. Those used in the clinic/laboratory, and the point of care (POC) rapid diagnostic kits used in personal and home tests. These different usage environments present very different challenges, that this proposal will address. Despite the reduction of personal/home medical testing as the COVID-19 pandemic abates, POC testing exceeds 400 million tests worldwide each year on account of their widespread use for diagnosis of diseases such as tuberculosis, malaria and AIDS, as well as for home pregnancy tests and diabetic blood tests. Moreover, the use of POC tests is predicted to grow as we expand the range of low-cost testing for other diseases (especially in low to middle income countries), face new epidemics and pandemics (i.e. bird flu or monkey pox) and change the delivery of medical services towards virtual interactions between patients and healthcare practitioners, accompanied by increasing normalisation of home testing for illness. Similarly, the plastic waste generated in clinical settings, such as in the NHS, presents a growing concern, with new technologies and treatments highly sought after. In NHS England alone, diagnostic testing has reached record levels in 2022, again, strongly evidencing the need for treatment of these plastics. Given the lab-based setting though, these plastics may facilitate a different, perhaps simpler, route to circularity compared to personal diagnostic testing kits which are used by the public away from the clinical settings. To this end, this proposal is focussed on addressing the challenge of creating a circular economy for medical testing waste, both in clinical settings (i.e. hospitals, labs, etc) and away from the clinic, in homes and elsewhere. The research will not only create new solutions that are based on pioneering, novel fundamental science and engineering but it will also take a whole systems approach that incorporates an exploration of the economic, social and environmental challenges that it will be essential to address in order to create a sustainable circular economy for medical testing plastics.