Validation of a novel PD diagnostic device in the laboratory
Research type
Research Study
Full title
Validating an in vitro diagnostic test for the detection of bacteria and leukocytes in peritoneal dialysis effluent in the laboratory
IRAS ID
249277
Contact name
Nishal Govindji-Bhatt
Contact email
Sponsor organisation
Microbiosensor Ltd.
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Microbiosensor are developing a diagnostic test which can detect bacteria and leukocytes present in peritoneal dialysis effluent with a simple, visible, colour change. It is intended that this will help patients undergoing peritoneal dialysis detect infective peritonitis more rapidly, and reliably, than they can at present. The colour can be seen before the effluent becomes obviously cloudy. In addition, the device indicates whether any bacteria present are sensitive to vancomycin, suggesting that they are gram-positive, or resistant to vancomycin, suggesting that they are gram-negative. The Gram positive/negative status is useful to clinicians to help determine the source of infection. It is intended that the test will ultimately be used by the patient in their home.
In the proposed study peritoneal dialysis effluent from patients with, and without, peritonitis will be collected. It will be transported to the Microbiosensor laboratory and used to optimise and validate the device performance.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0270
Date of REC Opinion
11 Jul 2018
REC opinion
Favourable Opinion