Evaluation of Biomarkers in Biobanked Cystic Fibrosis Samples
Research type
Research Study
Full title
Evaluation of Alkyl-Quinolone Biomarkers in the Cystic Fibrosis Foundation Biobanked Urine Samples Using LC-MS/MS and the MiDx Lateral Flow Device
IRAS ID
370097
Contact name
Simone Lucanto
Contact email
Sponsor organisation
Cystic Fibrosis Foundation
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
Lung infections are a major problem for people with Cystic Fibrosis (CF). One of the most common infections is caused by the bacterium Pseudomonas aeruginosa. Previous studies have shown that this organism produces small signalling molecules during infections, particularly when it becomes more virulent.
MiDx is developing a lateral flow device (similar to a COVID-19 home test) designed to detect these molecules in urine. If successful, this type of test could help identify infections in people with CF using a simple, non-invasive sample.
In this study, MiDx will analyse urine samples that were previously collected as a part of the PROMISE study conducted by the Cystic Fibrosis Foundation. The participants already consented for their samples to be stored and used for research. No new samples will be collected and no contact with participants will occur.
The study will have two main elements. Firstly to investigate whether the urine samples provided contain these signaling molecules and in what quantities. This will be done using an analytical method called Liquid Chromatography-Mass Spectrometry. Secondly, MiDx will test whether the lateral flow device under development gives comparable results from the same urine samples and whether this data matches the clinical information associated with the samples regarding the level of Pseudomonas infection at the time of urine collection. This will indicate whether the signaling molecules are a promising way of detecting Pseudomonas infection and whether the lateral flow device could be a useful diagnostic tool for people with Cystic Fibrosis.REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0120
Date of REC Opinion
10 Apr 2026
REC opinion
Favourable Opinion