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Comparative Performance Analysis of Three Point-of-Care Glucose Testing Devices against a Central Laboratory
Auliya Ashar1, Fauqa Arinil Aulia2,3, Ferdy Royland Marpaung2,3
1Clinical Pathology Study Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.
Background:
Point-of-care testing (POCT) glucose systems are widely used in clinical practice due to their rapid turnaround time and operational convenience. However, concerns remain regarding their analytical agreement with laboratory reference methods, particularly in relation to accuracy and potential clinical impact.
Methods:
This cross-sectional analytical study included 196 adult outpatients at Dr. Soetomo General Academic Hospital, Surabaya, Indonesia. Capillary blood glucose was measured using three POCT devices (StatStrip, Accu-Chek Inform II, and Rightest), while venous plasma glucose was analyzed using a hexokinase-based reference method (Alinity C). Analytical performance was evaluated using correlation analysis, Bland-Altman plots, Passing-Bablok regression, and ISO 15197 accuracy criteria.
Results:
All POCT devices demonstrated strong correlations with the reference method (r = 0.967-0.982; p < 0.001). StatStrip showed a small negative bias (-2.89 mg/dL; p = 0.003), while Accu-Chek Inform II exhibited a larger deviation (-7.80 mg/dL; p < 0.001). In contrast, Rightest showed no statistically significant bias (-0.14 mg/dL; p = 0.870) and demonstrated the closest agreement with the reference method. Agreement analysis confirmed minimal systematic and proportional bias for Rightest, whereas Accu-Chek Inform II showed wider variability. ISO 15197 evaluation indicated the highest accuracy for Rightest and lower compliance for Accu-Chek Inform II, particularly at glucose levels <200 mg/dL.
Conclusion:
Although all POCT systems showed strong correlations with the reference method, clinically relevant differences in analytical agreement and accuracy were identified. Rightest demonstrated the best overall performance. These findings highlight the importance of evaluating agreement beyond correlation and support the use of POCT primarily for glucose monitoring rather than definitive diagnosis.
