Social Technologies
Authors: Nicola Mountford, Assistant Professor, School of Business, Assisting Living and Learning Institute (ALL), Maynooth University and Sean Doyle, Professor, Department of Biology, Maynooth University
Over 32,000 neonatal deaths occur per annum in Uganda, with sepsis accounting for 20% of this death rate – that’s 6,500 newborn babies who die of sepsis in just one country in the world. That’s not all, sepsis also accounts for almost a quarter of maternal deaths in Uganda. Our project, NEOSEPSIS, aims to reduce these numbers by introducing an easy-to-use, 15 minute lateral flow test to help to better diagnose sepsis in resource limited environments, such as Uganda.
The test detects Serum amyloid A, or SAA – a globally validated biomarker of sepsis. The lateral flow test used in this process is very similar to the type of antigen test that you might have used to help diagnose whether or not you had Covid-19. It is just as user-friendly, rapid, and equipment-free as one of those Covid antigen tests. This makes it particularly suited to environments where it might be difficult to take, store and transport samples.
What really makes this a potential game-changer, however, is the very small amount of blood required to run the test. One tiny pinprick of a blood sample (5 µl) is all that is needed and this can be easily and painlessly accomplished through a standard heel prick test. This stands in stark contrast to the very upsetting, painful, and often ultimately unsuccessful efforts required to secure the volume of blood necessary for other diagnostics (such as Complete Blood Count (CBC) or C-Reactive Protein (CRP) tests) from a tiny newborn baby.
That is what brought us together as a consortium – Prof Sean Doyle from Maynooth’s Biology Department who brings the scientific knowledge; Kieran Walshe of Accuplex Diagnostics contributes with both commercial and manufacturing experience; Mandy Daly of the Irish Neonatal Health Alliance provides the project with knowledge surrounding patient understanding; Prof Peter Waiswa and Dr Flavia Namiiro of Makerere University, situated in Kampala, Uganda, have the paediatric knowledge and experience; and Dr Nicola Mountford, in the School of Business with experience in market organization and health technology adoption research. We applied for funding under the Future Innovator Award co-sponsored by Science Foundation Ireland and Irish Aid and we have been successful in both concept and seed funding rounds to-date.
So far, we have successfully manufactured the test kits, and learned how to follow all approval and customs processes necessary to have them shipped them to Uganda. Project partners, Makerere University, have led a first-phase clinical study in which 500 samples have been gathered to-date from both adults and newborns, with and without evidence of sepsis. Early results are promising, and we are currently embarking on phase two of the study that will see almost 1,000 samples tested across both hospital and field-based mothers and babies.
Alongside the clinical studies, we are also studying the structure of the healthcare technology market in Uganda and the process of technology adoption in this context. To do so we have been engaging with stakeholders from the multiple organisations and cohorts involved in decision-making – from paediatricians to midwives; policy-makers to lab technicians. To-date we have conducted over 35 interviews with such stakeholders. We are also examining policy and practice documentation to map the process of market entry and approval for a new health technology in Uganda.
Our goal is to find out whether the test will improve sepsis diagnosis in very difficult environments – ones that combine difficulties in extracting blood with resource constraints that limit the availability and affordability of laboratory testing. Having done that, our challenge now is to find a way of getting that test into the hands of those that need it on a long-term basis. We have made good progress on our journey and developed important insights and relationships that will help us to complete the task.