Improved Legionella Urinary Antigen Test
Research type
Research Study
Full title
DEVELOPMENT AND CHARACTERISATION OF ANTIBODIES FOR THE PRODUCTION OF A NEW AND IMPROVED URINARY ANTIGEN TEST FOR LEGIONELLA
IRAS ID
214798
Contact name
Vicki Chalker
Contact email
Sponsor organisation
Public Health England
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Legionnaires’ disease is a severe pneumonia and a significant public health concern. Rapid diagnosis is key to identifying cases and limiting public health impact. The Urinary Antigen Test has been the frontline tool to identify Legionella infections for decades. It is fast, cheap and can be performed at the patient bedside. However, false positives and negatives occur and assays have undefined specificity to non L. pneumophila sg-1 infections. It is estimated that >15% of Legionella infections are caused by non-L. pneumophila sg-1 strains and these currently go undiagnosed. Failure to detect these infections can lead to non-identification of outbreaks and clusters, increased hospital stay and potentially increased mortality. This project between Biosafety RVPBRU, and the German Reference lab at the Technical University of Dresden will use existing expertise to characterise commercially available and new antibodies specific to urine-soluble antigens of L. pneumophila sg-1, L. pneumophila non sg-1 and other clinically relevant Legionella spp in addition to creating a Mab2 positive and Mab2 negative test. Candidate Abs will be validated against clinical urine samples held by RVPBRU. Chosen Abs will be incorporated into a novel urinary antigen test to augment/replace existing assays in use in RVPBRU thus improving service delivery. Such a test would augment LD diagnostic capability, increase patient outcome and identify cases that currently go undetected.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1946
Date of REC Opinion
14 Nov 2016
REC opinion
Favourable Opinion