Diagnostics

The ISO-accredited Leicester Molecular Diagnostics (LMD) facility has been established within the Leicester Cancer Research Centre to provide a comprehensive service for molecular oncology testing and support translational research aspects of clinical trials. The facility also works closely with industry to beta-test new kits, reagents, equipment or companion diagnostics and with contract research projects.

Characterising low levels of Mycobacterium tuberculosis infection to determine tuberculosis risk

Dr Pranab Haldar is a Consultant Respiratory Physician and Clinical Senior Lecturer in Respiratory Medicine. In collaboration with Professor Catherine Rees and her team at the University of Nottingham and PBD Biotech Limited, Pranab proved that a novel bacteriophage-based diagnostic, Actiphage, which detects the presence of mycobacteria that cause tuberculosis (TB), could be used in patient blood samples.

LD3 aided the proof of concept clinical study by optimising the patient blood sample collection, storage and processing protocols, setting the Actiphage assay up at the NIHR Leicester Biomedical Research Centre, and modifying the Actiphage assay (initially developed for animals) for optimum performance with human blood samples. LD3 analysed clinical samples for the study, and trained UHL and University of Leicester staff in the assay. The study reported a diagnostic sensitivity of 73 % and specificity of 100% in pulmonary TB and proved the ability of Actiphage to detect metabolically active Mycobacterium tuberculosis within white blood cells. In addition, Dr Halder was able to show that clinical features of incipient tuberculosis can be visualised on PET-CT and are associated with Mycobacterium tuberculosis detection in the blood by the Actiphage assay. Read the paper.

Overall, the team have shown that Actiphage can be used for early diagnosis of people at risk of TB disease, which in future could enable targeted preventative treatment and stop the spread of infection within communities.

PBD Biotech Limited specialises in the use of novel bacteriophage-based technology. The company has developed proprietary, patented technology that can be used to detect the presence of mycobacteria that cause tuberculosis in humans and animals in a blood sample.

Lyme disease detection

Professor Martha Clokie is a world expert in the isolation and identification of bacteriophages, particularly those related to human and animal diseases. Martha is working with a French based charity (Phelix) to develop an improved assay to detect Lyme disease caused by infection with the bacterial species Borrelia.

Phelix is in the process of commissioning a new phage based PCR for Borrelia species based on Martha's work, that has an increased sensitivity by 50% when compared to current available tests. It has also been experimentally confirmed that this phage-based PCR showed significantly increased sensitivity compared to the traditional 5S-23S intergenic region based PCR.