Method comparison and bias estimation of point of care creatinine test
Research type
Research Study
Full title
Method comparison and bias estimation of two point of care tests against standard of care laboratory testing by enzymatic method.
IRAS ID
202240
Contact name
Martine Harris
Contact email
Sponsor organisation
Mid Yorkshire Hospitals NHS Trust
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Potential strategies for service delivery improvement across healthcare include the use of new diagnostic technologies. Within radiology patients need a blood test before having some examinations, when they need an injection of x-ray dye, to ensure the kidney function (estimated Glomerular Filtration rate (eGFR) is normal. The blood test allows patients with reduced kidney function to be identified as there is a risk of contrast-induced acute kidney injury (CI-AKI) as a result of the injection of x-ray dye.
We aim to test whether a point of care test (POCT) for bloods is as accurate as a standard pathology test to enable it to be considered for use in radiology to improve patient care pathways. This will enable us to develop a trial to evaluate the impact of POCT on a Radiology service.
In this study we propose to perform additional blood tests utilising two POCT devices on outpatients routinely referred to phlebotomy for blood (U&E) testing as part of their standard pathway. Patients will be identified as attending for U&E’s in the phlebotomy department and those attending for other blood tests will be excluded.
Patients identified will be recruited and consented for their agreement to have both a standard pathology blood test and a POCT (using both venous and capillary finger prick) blood. Accuracy using method comparison and bias estimation will be carried out on the patient samples in accordance with established laboratory standards.To ensure patients with a range of blood results are identified we will use a modified Choyke screening questionnaire to identify those with potentially reduced kidney function who would be the group most at risk in any future radiology based studies.REC name
South East Scotland REC 02
REC reference
16/SS/0077
Date of REC Opinion
8 Apr 2016
REC opinion
Further Information Favourable Opinion