A-373 Clinical Evaluation of a Handheld Point-of-Care Electrochemical Creatinine Assay for Kidney Function Monitoring

Background Kidney diseases, including acute kidney injury (AKI) and chronic kidney disease (CKD), are major global health concerns, causing significant morbidity, mortality, and healthcare costs. Serum creatinine is the most widely used biomarker for kidney function and is recommended by clinical guidelines for estimating glomerular filtration rate (eGFR). However, traditional creatinine testing methods require specialized equipment and trained personnel, limiting accessibility, particularly in remote or home settings. Eaglenos has developed a handheld point-of-care testing (POCT) creatinine assay using electrochemical technology for both in-hospital and at-home kidney function monitoring. This system provides a rapid and accessible solution for kidney health assessment, aiding in early detection and management of kidney diseases. This study evaluates its accuracy against reference methods and compares clinical performance, including usability by professionals and non-professionals. Methods Venous whole blood samples were collected by healthcare professionals using lithium heparin-coated tubes. Fingertip capillary blood samples were collected by both healthcare professionals and non-professionals. The study included three comparisons: 1) Analytical performance —Comparison of the Eaglenos system and the reference system (Abbott i-STAT CHEM8+) for venous whole blood samples. 2) Sample consistency—Comparison of venous and fingertip capillary whole blood samples using the Eaglenos system. 3) Usability assessment—Comparison of fingertip capillary blood samples tested by healthcare professionals and non-professionals using the Eaglenos system. Deviation analysis, Bland-Altman analysis, regression analysis, and bias at medical decision levels were used to assess the agreement, correlation, and accuracy. Results A total of 240 cases were analyzed with no dropouts. The main results are: 1) The comparison between the Eaglenos system and the Abbott system using venous whole blood creatinine measurement showed a correlation coefficient (r) of 0.9957 and a coefficient of determination (R2) of 0.9914. 2) The comparison between fingertip capillary whole blood versus venous whole blood creatinine measurements using Eaglenos system yielded an r of 0.9953 and an R2 of 0.9907. 3) The comparison between trained professionals and the non-professionals demonstrated an r of 0.9963 and an R2 of 0.9926. Bland-Altman analysis showed that more than 95% of the data points fell within the limits of agreement (LoA) for both the ratio and percentage difference analyses. All comparisons met the deviation standard, with bias at medical decision levels remaining below 6%, equivalent to ½ the total allowable error (TEa). Conclusion The Eaglenos handheld POCT creatinine assay demonstrated excellent accuracy across venous whole blood, fingertip capillary whole blood, and self-testing scenarios. The system exhibited strong correlation with reference methods, ensuring its reliability for kidney function assessment. With its user-friendly design, this POCT system is well-suited for both in-hospital and at-home monitoring, providing a rapid and accessible kidney health assessment. Its performance at medical decision levels supports its potential for early detection and management of kidney diseases.