Sputum Collection for Inflammatory Biomarker Assay Development
Research type
Research Study
Full title
Development of diagnostic tools for the rapid detection of markers of inflammation within the clinic
IRAS ID
152908
Contact name
Damian Downey
Contact email
Sponsor organisation
Queen's University Belfast
Research summary
This study seeks to develop a robust and simple tool to allow critical markers of disease and infection to be measured directly in the clinic. We have developed a novel technology and a range of unique molecules, known as Protease-Tags™, which have the capacity to rapidly and selectively bind molecules of interest. By harnessing this potential and combining it with known development technologies we believe we have the opportunity to produce a novel, reliable point of care (POC) test which could easily be incorporated into the clinic for the routine analysis of samples. One particular enzyme, neutrophil elastase (NE), has been well established as a biomarker of infection and the progression of respiratory diseases including Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD). However, it is only measured in airways samples during research studies and in clinical trials assessing the usefulness of new therapies. NE is not measured with the Clinical Biochemistry departments of hospitals. Respiratory consultants have stated in many forums that routine NE assessment in the clinic would provide important biochemical information which would, alongside pulmonary function data, help to ascertain the extent of infection and assist with the prescribing of antibiotics. An opportunity therefore exists to develop a product which would have potential to be incorporated into the routine assessment of patients during clinic visits, as well as being a useful tool for the pharmaceutical industry. Previously, we have clinically validated our technology in its ability to detect and measure NE within sputum samples from CF patients utilising our novel ‘NE-Tag™ ELISA’. We need to further progress this development by transferring our technology to the POC test, known as a lateral flow device (LFD). To facilitate this, we require a range of airway samples with which to assess assay dynamics, optimisation and validation of prototype LFDs.
REC name
West of Scotland REC 5
REC reference
14/WS/1040
Date of REC Opinion
3 Jul 2014
REC opinion
Favourable Opinion