Comparative Evaluation of the Hemocue® Glucose 201 RT Point-of-Care Device and the Mindray BS-240 Analyzer for Blood Glucose Measurement in a Clinical Laboratory Setting.

Abstract

Background: The Hemocue® Glucose 201 RT is widely used in the Democratic Republic of Congo; however, local validation data are lacking. This study aimed to compare glucose measurements obtained with the Hemocue® Glucose 201 RT device against those from the Mindray BS-240 analyzer to assess its suitability for implementation within the University Clinics of Kinshasa.

Methodology: A cross-sectional, descriptive, and analytical study was conducted from May to June 2025. Venous blood samples (5 mL) were collected in sodium fluoride tubes, with immediate whole-blood glucose measurement performed using the Hemocue® Glucose 201 RT and plasma glucose measured within one hour using the Mindray BS-240 analyzer. Agreement between methods was assessed using Pearson correlation, Lin’s Concordance Correlation Coefficient (CCC), Bland–Altman analysis, accuracy index (P10), RMSE, and Deming regression.

Results: A total of 150 samples were analyzed. The Hemocue produced a mean glucose value of 104.7 ± 30.5 mg/dL, while the BS-240 yielded 99.5 ± 30.6 mg/dL. A very strong correlation was observed (r = 0.99; p < 0.0001), though overall concordance was moderate (CCC = 0.43 [0.38–0.48]). The Hemocue demonstrated a mean positive bias of –5.16 mg/dL and a significant constant bias based on Deming regression (intercept = 4.27 [1.67–6.94]). Accuracy remained high, with 93.3% of samples within ±10% of the BS-240 values.

Conclusion: The Hemocue® Glucose 201 RT device showed strong correlation and acceptable clinical accuracy compared with the Mindray BS-240 analyzer, despite evidence of systematic overestimation. The device is appropriate for emergency and resource-limited settings, though result interpretation should consider observed bias.