Noninvasive, Multiplex and Portable Testing of Urea and Potassium to Enable Patient-Centered Monitoring of End-Stage Chronic Kidney Disease
Noninvasive, Multiplex and Portable Testing of Urea and Potassium to Enable Patient-Centered Monitoring of End-Stage Chronic Kidney Disease
This study evaluates the clinical performance of a non-invasive digital diagnostic test (KF4+, developed and manufactured by Gisens Biotech) for the measurement of urea and potassium in capillary blood in patients with end-stage renal disease (ESRD) undergoing dialysis. Measurements obtained using the KF4+ test in capillary blood are compared with hospital laboratory reference methods performed on venous blood samples. The study also assesses the feasibility of determining dialysis efficiency, expressed as Kt/V, using non-invasive samples. The objective is to determine agreement, correlation, and clinical comparability between methods, and to evaluate the use of capillary blood as an alternative to venous sampling in routine dialysis monitoring.
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Exclusion Criteria:
The adequacy of dialysis treatment is traditionally assessed by measuring serum urea and calculating Kt/V, which requires venous blood sampling and laboratory infrastructure. This observational diagnostic study evaluates the use of a portable, bioelectronic point-of-care test (KF4+, Gisens Biotech) for measuring urea and potassium in capillary blood as a non-invasive alternative. KF4+ test is a disposable cartridge based on electrochemical detection of analytes inside.
Adult patients with end-stage renal disease undergoing chronic hemodialysis from Hospital Interzonal General de Agudos "General San Martín" are enrolled. Capillary blood samples are collected before and after dialysis sessions and analyzed using the KF4+ digital test. Venous blood samples collected at the same time points are analyzed using standard hospital laboratory reference methods with the autoanalyzer Wiener Lab CMD 800i. Method comparison analyses are performed to evaluate agreement and correlation between capillary and venous measurements.
Dialysis efficiency is assessed by calculating Kt/V using urea values obtained from capillary blood and comparing these results with Kt/V calculated from venous blood measurements. The study is conducted at a single hospital center and follows a paired, comparative, observational design. KF4+ results were not used for clinical decision-making.