Award Title: NIHR Global Health Research Group on Digital Diagnostics for African Health Systems
Funder: Department of Health and Social Care

Abstract: Research questions: _x000D_
1. How does a lab-on-chip digital diagnostic perform under different use-cases in African healthcare settings and how can it be optimised for use? _x000D_
2. How can digital diagnostics like this best be integrated into healthcare practice and policy in Africa?_x000D_
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Background:_x000D_
Most of the population of Africa do not have access to diagnostic tests on the WHO essential list. Digital diagnostics have potential to transform this situation, enabling highly accurate diagnostics to be brought to where they are most needed. Digital diagnostics use lab-on-chip technology to detect analytes, generating, processing, storing, and transmitting digital data, with real-time connectivity, providing actionable results to the user and data for disease surveillance. We have developed a modular digital molecular diagnostic platform called Lacewing, which features the sensitivity of PCR in a handheld, easy-to-use, robust, rapid, and cheap, sample-to-answer format, suitable for point-of-need diagnosis in African healthcare settings. We have developed a series of tests for different diagnostic situations including detection of malaria parasites and other pathogens, and distinguishing causes of childhood febrile illness. Data from each diagnostic test is transmitted to a smart phone which provides the user interface and secure onwards transmission of data. _x000D_
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Aims and objectives:_x000D_
To develop an evidence-base to support the development, implementation, and impact of digital diagnostic technology in African health systems, whilst training a cohort of African Digital Diagnostic Fellows who will be the future proponents of this technology. We will evaluate this in the context of the following use-case scenarios i) Malaria: community screening and clinical management; ii) Management of childhood febrile illness; iii) Environmental pathogen detect._x000D_
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Methods:_x000D_
Formative research will involve situation analyses, user stories, focus group discussions (FGDs) and key-informant interviews (KIIs), which will be analysed using principles of  human-centred design, the social-ecological model of behaviour and diffusion of innovation theory. Participatory co-design will be used for definition, ideation, prototyping, and testing, of Lacewing in different use-case scenarios. Diagnostic placement in health systems and potential impacts of digital diagnostics will be analysed and theory of change models developed. Diagnostic accuracy will be assessed against relevant gold-standard and commonly used comparator tests. Applications of data from digital diagnostics will be assessed using simulations and modelling based on data generated in prototyping and diagnostic accuracy studies and publicly available data._x000D_
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Timelines for delivery: _x000D_
The project will run over 48 months_x000D_
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Anticipated impact and dissemination:_x000D_
Through this pathfinder project based around a state-of-the-art, point-of-care digital molecular diagnostic device, we expect to generate multiple types of evidence to determine whether digital diagnostics would be feasible, viable, usable and sustainable solutions for high priority diagnostic gaps in Africa. Throughout the project we will involve users, stakeholders and policy makers, to ensure that the benefits of digital diagnostics have the best possible chance of being realized. By training a cohort of Digital Diagnostic PhD Fellows, we will establish increased capacity for digital diagnostic development, and adoption across Africa.

Lay Abstract: Aims of the research: _x000D_
We want to investigate whether a new type of diagnostic test, called a digital diagnostic, will be better than currently available diagnostic tests in African health care settings. We want to look at this in scenarios where there are important gaps in the availability, accuracy, or data collection from current diagnostic tests. These scenarios are: 1. detection of malaria parasites; 2. Cause of fever in young children; 3. detecting bacterial contamination of water and food. _x000D_
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Background to the research: _x000D_
Making the correct diagnosis when someone is ill ensures they receive the right treatment and have the best chance of getting better. In rich countries it is taken for granted that when someone is ill, all of the tests that are needed can be performed to reach a diagnosis. In much of Africa, most people do not have access to essential diagnostic tests, either because they live too far away from the relatively few laboratories that can offer these tests or because they cannot afford them. As a result most treatment is based on informed guesswork of the most likely cause. This results in overuse of antibiotics and antimalarial drugs, which in turn favours the development of resistance. _x000D_
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We have developed a digital diagnostic device, called Lacewing, which makes diagnoses by detecting tiny molecules from a drop of blood or saliva on the surface of a microchip and generates electronic signals. These signals are transmitted to a smartphone and give the user a diagnosis. Because the “lab-on-chip” does all of the work, the technology is very easy to use and enables very accurate diagnosis to be made by rapidly by a cheap, robust and fully portable handheld device. This means that the capability of an advanced diagnostic lab can now be taken to the patient.        _x000D_
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Design and methods used: _x000D_
We want to understand whether the Lacewing diagnostic will work properly, whether it will provide accurate diagnoses, and whether we can optimise it to give the maximum chance that it is adopted into practice in African healthcare systems. To do this, we need to fully understand the context in which it will be used, and understand the perspectives of all of those who might be impacted, from the patients and healthcare workers right up to ministries of health and international policy makers. We do this through different types of interviews and focus groups. We optimise the design of Lacewing in partnership with the intended users – so called “co-design”. We assess the potential impact on health systems to understand how other aspects of diagnosis and care might be affected. We compare accuracy of diagnoses using Lacewing against those of the best possible "gold standard" diagnostic tests, and also against any tests in common use in Africa. _x000D_
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Community Engagement and Involvement: _x000D_
The involvement of community members, as potential end-users of the diagnostics, is central to the co-design process. Wider community engagement will be undertaken for the diagnostic accuracy studies to ensure that the research is appropriate and approved by the local communities. _x000D_
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Dissemination:_x000D_
Dissemination is an essential component of our work. We want to share our results widely with communities in Africa, with policy makers, and with the commercial sector. We will do this using creative tools, videos and demonstrations, to raise awareness of the potential of digital diagnostics to transform health care in Africa.

Research Activity Codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;7.3 MANAGEMENT AND DECISION MAKING
Health Categories: INFECTION