ODx Pharmacy Sample Collection for Urine Diagnostic Test Development
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 Pharmacy Sample Collection for Urine Diagnostic Test Development
IRAS ID
281182
Contact name
Andy Sails
Contact email
Sponsor organisation
ODx Innovations Ltd
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Summary of Research
The aim of this study is to obtain urine samples from subjects with a suspected UTI presenting at study sites to the Pharmacist or MoD Medical Officer with UTI associated symptoms in order to calibrate and compare use of a new diagnostic point of care urine test against the standard reference urine tests. The study seeks to confirm whether the new test can produce rapid reliable information on urine infection and on the antibiotic sensitivity of any organisms detected, such that the company has evidence to support the further development of the test and instrumentation towards a future regulatory submission and commercial use.
Should this work prove successful, ODx has been advised by medical practitioners such a device used on urines for ICU and HDU patients being treated for Covid-19 could provide actionable clinical information much faster than existing methods. A reduction in the number of people presenting at A&E departments and progressing to admissions is an anticipated outcome from the use of the test.
The work will examine how the new testing method compares to current standard urine tests (in the company laboratory setting only) and establish early baseline data to support the development of the next generation prototype device.Summary of Results
Urine samples were donated by suspected UTI patients diagnosed by pharmacy staff applying the standard NHS Scotland protocol.The fresh urine samples were quickly transported to a neighboring laboratory and tested in the prototype ODx UTI test.
The ODx test results were compared against the standard laboratory culture, isolation and antibiotic susceptibility regime.
The 30 minute ODx test compared well against the 48 hr laboratory AST, providing high levels of accuracy in detecting the presence of bacteria in the patient's urine (confirming a positive UTI diagnosis), and in providing an antibiotic profile which corresponded well with the laboratory AST.
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 undertake these activities.
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 take any action to 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 share any of the study data or results.
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 offer any sharing.
Submitted on: 24/01/2023REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0942
Date of REC Opinion
20 Aug 2020
REC opinion
Further Information Favourable Opinion