Point-of-Care Testing Glucometer in Rapid Assessment Settings: Comparison of 2 Network-Capable Devices in a Referral Hospital.

Abstract

Background: Point-of-care testing (POCT) glucose meters are essential for rapid glucose monitoring. This study aimed to evaluate the analytical performance of 2 novel network-capable POCT glucometers, CobasPulse (Roche Diagnostic) and StatStrip (Nova Biomedical), in comparison to the Atellica CH 930 Analyzer (Siemens Healthcare), a central laboratory clinical chemistry analyzer, as a reference method.

Methods: A cohort of 150 patients' venous whole blood samples were analyzed. Method comparison was performed using Passing-Bablok regression and Bland-Altman plots. Precision studies were conducted using commercial controls, with assessment of within-run and between-run imprecision by experienced laboratory technicians. Performance was assessed against FDA 2020 benchmarks.

Results: Passing-Bablok regression showed accurate overlap for both POCT devices. CobasPulse exhibited a bias of -0.17 mmol/L and Pearson r of 0.982, while StatStrip showed a bias of -0.35 mmol/L and Pearson r of 0.959. Within-run CV for Cobas Pulse (3.3 mmol/L control) was 2.4%, and for StatStrip (3.44 mmol/L control) was 5.2%. Between-run CVs were 2.1% for Cobas Pulse and 3.2% for StatStrip at comparable glucose concentrations.

Conclusions: Both CobasPulse and StatStrip demonstrated acceptable concordance with the Atellica CH 930 Analyzer. While Cobas Pulse showed slightly better agreement and precision, both devices are suitable for glucose measurements in healthcare settings, providing reliable results and reduced turnaround time, supporting timely clinical decisions for rapid glycemic assessment.