NIHR Global Health Research Group on Digital Diagnostics for African Health Systems

Research questions:

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? 2. How can digital diagnostics like this best be integrated into healthcare practice and policy in Africa? Background:

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. Aims and objectives:

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.

Methods:

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.

Timelines for delivery: The project will run over 48 months Anticipated impact and dissemination:

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.