Comparison and Analytical Validation of the Nova Max Pro Creatinine/eGFR Meter against Nova StatSensor Creatinine Meter

Abstract

Chronic Kidney Disease (CKD) represents an escalating global and national health challenge, affecting millions of individuals and imposing substantial healthcare costs. Early diagnosis and continuous monitoring of renal function are crucial to mitigate disease progression and associated complications. Point-of-care (POC) testing devices have emerged as efficient tools for the timely assessment of kidney function outside centralized laboratories. Among these, the Nova StatSensor Creatinine Meter has been widely used to measure blood creatinine and estimate glomerular filtration rate (eGFR). The Nova Max Pro, a newer-generation POC device, integrates enhanced analytical capabilities and operational features suitable for decentralized and resource-limited healthcare environments. This study aimed to evaluate the analytical performance, clinical comparability, and operational reliability of the Nova Max Pro system relative to the Nova StatSensor device.
Objective: To assess the analytical accuracy, clinical equivalence, and reproducibility of the Nova Max Pro Creatinine/eGFR Meter System compared to the established Nova StatSensor in the measurement of whole blood creatinine across clinically relevant concentration ranges.
Methods: A comparative analytical study was performed using 14 venous whole blood samples, covering a creatinine concentration range of 0.3 to 7.0 mg/dL, representative of values observed across CKD stages. Each sample was analyzed using two Nova StatSensor meters and four Nova Max Pro meters. The mean creatinine value obtained from the StatSensor devices served as the reference comparator. Linear regression analysis was used to evaluate correlation, bias, and agreement between the two systems. Testing was conducted by trained healthcare professionals following Good Clinical Practice (GCP) standards to ensure procedural reliability and data integrity.
Results: The Nova Max Pro demonstrated excellent correlation with the Nova StatSensor, yielding a regression equation of y = 0.9967x – 0.0014 and a coefficient of determination (R² = 0.9978). Minimal analytical bias was observed, and precision remained strong across the full creatinine range. All four Nova Max Pro units displayed consistent performance, indicating high reproducibility and stability. The device accurately detected creatinine values at key clinical thresholds critical for CKD staging, confirming its analytical validity.
Conclusions: The Nova Max Pro exhibited robust analytical agreement, minimal bias, and consistent precision compared to the Nova StatSensor. Its integrated Bluetooth connectivity, CKD-EPI 2021 equation support, and user-friendly design enhance its clinical applicability. These attributes position Nova Max Pro as a reliable, scalable, and field-ready solution for CKD screening and monitoring in community health programs, primary care centers, and resource-limited settings.