Testing a novel aid to diagnosis of peritonitis in clinic v1
Research type
Research Study
Full title
Testing a novel aid to diagnosis of peritonitis in clinic
IRAS ID
250220
Contact name
Gordon Barker
Contact email
Sponsor organisation
Microbiosensor Ltd.
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Summary of Research
Microbiosensor are developing a test to aid the diagnosis of peritonitis in dialysis patients. The test can detect bacteria and leukocytes present in peritoneal dialysis effluent with a simple, visible, colour change. At a later stage, once validated for use with patient, it is intended that this device will help patients undergoing peritoneal dialysis detect infective peritonitis more rapidly and reliably than they can at present, in their own homes. The colour may 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. In subsequent studies, it is intended that the test will ultimately be used by the patient in their home and the result will help clinicians in their treatment choice for the patient.Previously, Microbiosensor have collected patient effluent for use in the development of the device in a laboratory setting. The proposed study is a stepping stone to validate how the manufactured device performs in a clinical environment with patient effluent, but in the hands of clinical staff only. Patients will not have any contact with the device.
The patient effluent will be collected into a separate container or syringed out of the effluent waste bag by clinical staff who have been trained to use the Microbiosensor device, the trained person will then introduce the effluent into the device. After an incubation period of 10 hours, the result will be recorded by the clinical staff but will not influence or change normal clinical practice and treatment.
Summary of Results
• 36 peritonitis, and 46 non-peritonitis samples have been tested following the protocol.
• For non-peritonitis samples 93% were called correctly in the study i.e. a specificity of 93% (study clinician readout) which met the target of >90%+/-10% specificity.
• For peritonitis samples an overall sensitivity of 83% has been achieved (by clinicians) which also meets the target of >90%+/-10% sensitivity.
• These values are based on our claiming the device can identify cases of peritonitis where leukocyte levels are > 106 cells/ml.
• For Gram positive bacterial peritonitis only 2/14 devices gave the correct readout.
• For Gram negative bacterial peritonitis 4/5 devices gave the correct readout • Further investigation will be required to determine why the Gram positive results are not as expected.
• Although the device met its primary study end-points, these were only narrowly met, and a vancomycin claim was not supported.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0765
Date of REC Opinion
23 Nov 2018
REC opinion
Further Information Favourable Opinion