Novel low cost diagnostic tools and their impact in Africa

Point of care testing is fundamental in delivering health and economic sustainability in the Global South. Our project will enable low cost, effective and accurate diagnosis of, in the first instance, two infectious diseases, namely malaria and schistosomiasis. This will be achieved using a novel very low cost paper diagnostic method that is able to quantify the infectious agent's DNA in a patient sample in a multiplexed assay. The platform will allow the measurement of several diseases at the same time, thereby increasing the efficiency of healthcare provision in often hard to reach settings, as well as establishing the species of the infectious agent (e.g. malaria), which will provide actionable information to healthcare professionals, where drugs have different levels of activity for different species, thus helping in reducing the potential emergence/increase of drug resistance.

We have already demonstrated the potential for these low cost assays as being both sensitive and specific and we now wish to develop new engineering approaches to improve their performance (in terms of their speed and ease of use) and evidence their impact so that they can find widespread application in both rural and urban environments in Uganda and Sierra Leone, and other endemic countries. As the assays are sensitive and quantitative, they have the potential to be used not only in the treatment of individuals, but also in eradication programmes, such as those advocated by the London 2020 accord, enabling the surveillance of disease re/emergence.

To help communicate the value of repeated treatments, we plan to develop new engagement tools based upon a novel mobile phone imaging platform that enables patients to visualise the infectious agent in a sample, and to see the outcome of interventions (whether these be through drug administration or physical/cultural changes such as access to improved sanitation or bed nets). We also propose to measure the impact of our novel diagnostic and imaging platforms by collection of suitable, realistic, logistically feasible metrics, and the potential impacts (including resources, health outcomes, employment, income) of the interventions. We will also feed these into newly developed and parameterised economic models to predict the long-term benefits specific interventions may have.

Finally, integral to the proposed research is an ambitious programme of impact, which includes public engagement over infectious disease diagnosis and STEM and capacity strengthening. We will also explore routes to delivery of the technologies both in the UK, where the provision of low-cost point-of-care diagnostics is of significant interest (through our industrial partners), and in LMICs. Our ambition is to explore whether, through not-for-profit business planning, we can develop the correct interactions with Governments, Hospitals and Charities/NGOs, to test whether we are able to scale the manufacturing of these devices, such that they can be made in Africa, for Africa, by Africans.

The project aims to create impact within Sub-Saharan Africa by enabling effective, accurate and low cost diagnosis of two infectious diseases, namely malaria and schistosomiasis. This will be achieved using very low cost paper diagnostics that are able to quantify the DNA in a patient sample in a multiplexed assay. We have already demonstrated the potential for these assays as sensitive and accurate and we now wish to improve their performance (in terms of their speed and ease of use) and evidence their societal impact so that they find widespread application in both rural and urban environments. In addition, by developing new mobile imaging technologies, we aim to develop techniques to enable and increase the amount and detail of information available near to the patient. We anticipate that this might have two consequences - firstly showing the true value of interventions to recipients, including treatment of disease or sanitation, and secondly providing new innovative methods to engage with schoolchildren and more generally the public over the subject of infectious disease and STEM studies and careers.

To understand our approaches one must be aware of the nature of the problem. There have been significant improvements in the treatment of infectious disease although despite this schistosomiasis still affects 258m people, causing anaemia, stunted growth and poor educational outcomes in children. If untreated, chronic disease affects the ability to work and can result in death. The disease burden has been estimated to account for 4.5m DALYs. Similarly, sub-Saharan Africa also accounts for ~88% of the 214m malaria cases and ~90% of the 438,000 deaths, worldwide. It is the leading cause of death for children <5yrs in Sub-Saharan Africa. It perpetuates a cycle of poverty, illnesses and mortality, affecting mostly poor women and children and costing Africa's economy $12b/year. Diagnosis is a key tool in the strategy towards the elimination of both diseases
By developing these new technologies and methods associated with low cost diagnostics and mobile imaging academics and commercial organisations will benefit in the short term. We already have examples of SME diagnostic companies and those involved in low cost additive manufacturing who are interested in our paper-technology. FIND have expressed an interest in helping us develop the methods for neglected tropical diseases. In the longer term the diagnostic tools that we will develop will help governments and agencies quantify the effectiveness and societal cost-effectiveness of elimination programmes through mass drug administration and provide surveillance methods to monitor disease emergence/re-emergence.

In parallel with the core activities of scientific innovation in diagnostics and in mobile imaging we have a world-leading evaluation in health economics and will measure the impact of the proposed research by collection of suitable, realistic, collectable metrics, and the potential impacts of the interventions by feeding these into new economic models, that we develop during this programme.

Finally in Year 3 we will appoint a Grade 8 Impact Fellow who will spend three extended trips in Africa, exploring routes for the translation of the technology so it can be manufactured in Africa. They will also develop capacity strengthening activities with our established partners in the University of Rwanda and Makerere University as well as perform public engagement.