Validation of Precision and Accuracy of Point-of-Care Testing Glucose Analyzers with a Standard Laboratory Method (Glucose Oxidase Method)
TL;DR
POCT glucose meters should be used cautiously and primarily for monitoring trends rather than definitive diagnosis or therapeutic decisions, as they have limited reliability for critical clinical decision-making.
Abstract
Accurate blood glucose measurement is essential for the diagnosis and management of diabetes mellitus. This study evaluated the precision and accuracy of three point-of-care testing (POCT) glucose analyzers—Accu-Chek, Accu-ANSWER, and VivaChek—against the standard laboratory glucose oxidase method. A total of 97 participants were recruited, and venous blood samples were analyzed using both POCT devices and the reference method. Results demonstrated that all three POCT devices consistently overestimated blood glucose levels, exhibiting a systematic positive bias ranging from +18.56 mg/dL to +19.99 mg/dL. Bland–Altman analysis revealed wide limits of agreement and evidence of proportional bias, with inaccuracies increasing at higher glucose concentrations. Only 39.18% of measurements met the ISO 15197:2013 accuracy criteria (±15%), while over 40% deviated by more than 25%. Among the devices, VivaChek showed relatively better precision, whereas Accu-Chek demonstrated the widest variability and lowest agreement with the reference method. Despite their convenience and rapid turnaround time, the findings indicate that these POCT devices have limited reliability for critical clinical decision-making. The study concludes that POCT glucose meters should be used cautiously and primarily for monitoring trends rather than definitive diagnosis or therapeutic decisions.