Development and optimisation of molecular diagnostic tools for Lyme disease and Staphylococcus aureus bacteraemia

This project is focused on developing rapid diagnostic methods for molecular testing of blood samples. The project has progressed to specifically focus on developing tools for detecting Lyme disease and S. aureus bacteraemia in the clinical setting. Microgenetics Ltd have developed technology to detect single microorganisms in complex materials (the patented SwiftDetect method) for use in pharmaceutical and veterinary industries. Together with the University of Bristol, we aim to use this technology as the starting point for the development of rapid diagnostic tools for use in human healthcare settings. Initial stages will focus on the production of working assays for the target microorganisms in blood samples. Once the limits of detection have been optimised, we will collect clinical samples in association with Prof. Massey's clinical colleagues for appropriate testing of the developed assays. There is currently no direct molecular diagnostic test available for Lyme disease, so one of the aims of this project is to develop a direct Lyme disease test for use on blood samples from early-stage Lyme disease patients. S. aureus bacteraemia is currently diagnosed using culture-based methods which do not accurately indicate the bacterial load of infection. Therefore, the second aim of this project is to develop a rapid molecular diagnostic capable of quantifying bacterial load in S. aureus bacteraemia samples. There is also potential to develop this assay to determine presence/absence of key AMR markers in target organisms detected. The potential impact of this project is to provide novel, rapid and direct diagnostic assays to advance current diagnostic methods for Lyme disease and S. aureus bacteraemia. These novel methods could either replace or be performed alongside existing methods to provide the data required for effective and timely evidence-based patient treatments. In the context of rapid AMR marker detection, this has further implications for antimicrobial stewardship and the appropriate treatment of patients with antimicrobial resistant infections. This project falls within the EPSRC Healthcare Technologies research area. Specifically, the main project aims are both aligned the grand challenge of "Optimising Treatment: Optimising care through effective diagnosis, patient-specific prediction and evidence-based intervention". This project aligns with this as most Lyme disease cases are currently diagnosed without laboratory testing, and because S. aureus bacteraemia is currently diagnosed by relatively slow culture-based methods requiring secondary testing to determine antimicrobial resistance. These current diagnostics hamper our ability to effectively treat infected patients, causing increased suffering and cost. This project was established in collaboration between Microgenetics Ltd (a subsidiary of the Pharmaxo Group) and the University of Bristol. The project work so far has been carried out both at the Microgenetics site in Corsham, and in Professor Ruth Massey's research group at the University of Bristol, benefitting from the expertise of the research teams in both locations.