Cross-sectional evaluation of two point-of-care glucose meters against the GOD-PAP reference method
TL;DR
Both POCT devices demonstrated acceptable analytical agreement with the GOD-PAP method for blood glucose testing, however, Emtech BG Max 1 exhibited superior precision, lower analytical bias, and higher compliance with ISO 15197:2013, indicating greater reliability for routine clinical use.
Abstract
Introduction: Point-of-care testing (POCT) for blood glucose measurement is increasingly used because it provides rapid results for clinical decision-making. However, its analytical performance must be evaluated before routine implementation. This study aimed to compare the precision, accuracy, and agreement of the Easy Touch and Emtech BG Max 1 POCT devices with the Glucose Oxidase–Peroxidase (GOD-PAP) reference method for blood glucose measurement. Research Methodology: An observational analytic study with a cross-sectional design was conducted at the Buton Tengah Regional General Hospital Laboratory, Indonesia. Fifty venous blood samples were analyzed using the Easy Touch and Emtech BG Max 1 POCT devices and the GOD-PAP laboratory method as the reference standard. Precision was evaluated using the coefficient of variation (CV), accuracy was assessed through percentage bias and compliance with ISO 15197:2013, and agreement was determined using nonparametric Bland–Altman analysis. Results: The CV values were 5.54% for Easy Touch, 1.76% for Emtech BG Max 1, and 0.80% for the GOD-PAP method. The mean bias was 7.74% for Easy Touch and −5.78% for Emtech BG Max 1. Compliance with ISO 15197:2013 was achieved in 62% of Easy Touch measurements and 90% of Emtech BG Max 1 measurements. Bland–Altman analysis demonstrated good agreement between both POCT devices and the reference method. However, Emtech BG Max 1 showed narrower limits of agreement and closer agreement with GOD-PAP than Easy Touch. Conclusion: Both POCT devices demonstrated acceptable analytical agreement with the GOD-PAP method for blood glucose testing. However, Emtech BG Max 1 exhibited superior precision, lower analytical bias, and higher compliance with ISO 15197:2013, indicating greater reliability for routine clinical use. Periodic analytical performance evaluation is recommended to maintain the quality and accuracy of POCT-based blood glucose testing.