ODx Urine Sample Collection for Diagnostic Test Development (Stage 1)
Research type
Research Study
Full title
Can a new test for urine infections produce rapid reliable information on the antibiotic sensitivity of any detected organism? (Stage 1)- ODx Urine Sample Collection for Diagnostic Test Development
IRAS ID
272212
Contact name
Ewan Chirnside
Contact email
Sponsor organisation
NHS Highland
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Orbital Diagnostics (ODx) are developing a diagnostic test that detects small quantities of bacteria in urine samples provided from infected patients and this study, comparing the new technology with existing bacteriology tests (in the company laboratory setting only), aims to determine whether this test can produce rapid reliable information on urine infection and on the antibiotic sensitivity of any organisms detected. ODx diagnostic test is sensitive and rapid – the aim is 30 minutes from collection of urine to diagnosis. The test is designed as a point of care test to be used in GP practices/Health Centres that is easy to use and will improve patient outcomes, save money and help fight antibiotic resistance.
ODx require a large number of fresh urine samples from patients with suspected UTI, collected and tested within a few hours of the sample being given, to help develop the diagnostic test further and provide evidence to support the further development of the test and instrumentation towards a future regulatory submission and commercial use.
Participation in the study required the donation of urine samples from people who present to their GP practice with symptoms associated with a suspected UTI.
Participant normal care pathway and therapies are unaffected by the study. The study clinical intervention is the collection of urine samples.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1882
Date of REC Opinion
26 Nov 2019
REC opinion
Favourable Opinion