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
276252
Contact name
Ewan Chirnside
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 objective of this study is to obtain urine samples from volunteer subjects presenting at study sites in order to calibrate potential false positives and negatives of a new diagnostic point of care urine test.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
The study compared a novel, rapid point of care (POC) diagnostic test for urinary tract infections (UTI) with POC dipstick testing and laboratory culture, isolation and antibiotic sensitivity testing.Volunteer samples were provided by the general public by urine donation at ODx premises. The great majority of volunteer urines were negative for the presence of bacteria, allowing ODx to determine a baseline data set for their test of negative (normal) urine samples.
For those few volunteer urine samples which proved to contain relevant levels of bacteria, above the threshold of a UTI, the ODx test could provide evidence of infection (confirming the presence of a UTI) and provide an antibiotic sensitivity profile against six commonly-prescribed antibiotics within 30 mins.
These volunteer urine samples supported ODx' development of its novel test through a series of ever-improving prototypes.
REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0075
Date of REC Opinion
29 Jun 2020
REC opinion
Further Information Favourable Opinion