ODx Sample Collection in a hospital setting for Urine Diagnostic Test
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? ODx Sample Collection in a hospital setting for Urine Diagnostic Test Development
IRAS ID
286737
Contact name
Ewan Chirnside
Contact email
Sponsor organisation
ODx Innovations
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
ODx Innovations Ltd 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. The company 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.
The company require a large amount 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 requires the donation of a urine sample from people who present in a clinical setting with symptoms associated with a suspected UTI.
Participant normal care pathway and therapies are unaffected by the study. The study research activity is the collection of urine samples.Summary of Results
Hospital patients diagnosed with a UTI provided a urine sample for testing in the ODx system. The results of the ODx test were compared directly with the standard laboratory antibiotic susceptibility test.In comparison to the lab tests the 30 minute ODx test provided accurate results, detecting both the presence of bacteria in urine and their antibiotic sensitivity profile.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: ODx Innovations Ltd entered administration making all employees redundant, with the company's assets put up for sale by the Administrator.
As a consequence former employees lost access to their email accounts and company study data, so cannot provide any updates.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: ODx Innovations Ltd entered administration making all employees redundant, with the company's assets put up for sale by the Administrator.
As a consequence former employees lost access to their email accounts and company study data, so cannot follow nor complete the dissemination plan.
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: ODx Innovations Ltd entered administration making all employees redundant, with the company's assets put up for sale by the Administrator.
As a consequence former employees lost access to their email accounts and company study data, so cannot inform participants of any results of the study.
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: ODx Innovations Ltd entered administration making all employees redundant, with the company's assets put up for sale by the Administrator.
As a consequence former employees lost access to their email accounts and company study data, so cannot enable any sharing.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: ODx Innovations Ltd entered administration making all employees redundant, with the company's assets put up for sale by the Administrator.
As a consequence former employees lost access to their email accounts and company study data, so cannot provide any sharing.
Submitted on: 24/01/2023REC name
West Midlands - Solihull Research Ethics Committee
REC reference
20/WM/0228
Date of REC Opinion
6 Aug 2020
REC opinion
Favourable Opinion