Renal function Assessment with Point of care creatinine testing In Diverse populations (RAPID)
Chronic kidney disease
This is a multi-centre cross-sectional and prospective longitudinal cohort study. Primary objectives include assessment of Point of Care Creatinine (POC-Cr) accuracy and precision in order to define thresholds for screening which identify individuals with Chronic Kidney Disease (CKD) (Study A) and exploration of variability and patient acceptability of self-monitoring of POC-Cr including Ease or Simplicity of Use (Study B). 375 participants (including at least 125 of African/African-Caribbean ancestry and 125 Asian background) having venous serum creatinine and 99mTc-DTPA nuclear medicine testing will be recruited to a cross sectional study (Study A). 40 patients with CKD or at risk of kidney disease will be recruited to a one week longitudinal study (Study B). Study A: POC-Cr will be assessed on a drop of capillary whole blood by the research team and venous serum creatinine for routine care (Isotope Dilution Mass Spectrometry (IDMS) Traceable Enzymatic assay) and 99mTc-DTPA glomerular filtration rate testing will be extracted from hospital laboratory databases. Study B: Participants will be trained to use the StatSensor® by the research team and time taken recorded. Participants will be taught how to perform quality controls, finger prick lancing and sample analysis. All sample results will be digitally recorded by the device and downloaded after the device is returned. Participants will be asked to self-monitor four times per day (first thing in morning, midday, before evening meal/early evening, before bed) and each test recorded in a paper diary or electronically as desired. Details reported will include time of test, test success, device and non-device failures (test results, missed testing and reasons for missed test (e.g. forgot, did not want to test) and adverse events (e.g. pain, infection, pre-syncopal or syncopal episode).
1. 18 years of age or older 2. Willing to complete all study procedures 3. Patients undergoing formal nuclear medicine glomerular filtration rate testing (Study A only) 4. Has Chronic Kidney disease (CKD) KDIGO criteria or is at risk of CKD due to heart disease or diabetes as determined by physician (Removed 16/06/2026: Study B only)
1. Unable or unwilling to give informed consent 2. Any condition which would make finger prick contraindicated e.g. severe skin conditions, bleeding disorder 3. Study A: If formal GFR testing has been requested only because estimated GFR is not considered to reflect true GFR (e.g. liver disease)