Validation of Point-of-care Testing Device HemoCue® Glucose 201RT in Blood Glucose Estimation.

INTRODUCTION: We aimed to conduct this study to compare the validity of the HemoCue® Glucose 201 RT System (point-of-care testing (POCT) device) in estimating blood glucose levels in patients attending a tertiary care hospital, considering the automated analyzer method (Vitros® 4600 chemistry system, QuidelOrtho Corporation, USA) as the gold standard. METHODS: We conducted this study among the patients attending the outpatient department in a tertiary care hospital in Eastern India. Venous blood was collected to estimate fasting blood glucose (FBS) and postprandial blood glucose (PPBS) using the automated analyzer and the POCT device, along with capillary blood to estimate FBS and PPBS using the POCT device. RESULTS: We enrolled 200 patients with a mean age of 49.4 (standard deviation 12.6) years. Lin's CCC for POCT device compared to automated analyzer (venous blood) for FBS estimation was 0.95 (95% confidence interval (CI): 0.94 to 0.96, P value < 0.001) for venous blood and 0.95 (95% CI: 0.94-0.97, P value < 0.001) for capillary blood. Lin's CCC for PPBS estimation was 0.99 (95% CI: 0.98-0.99, P value < 0.001) for venous blood and 0.98 (95% CI: 0.97-0.98, P value < 0.001) for capillary blood. CONCLUSION: The POCT device showed substantial concordance with the gold standard method for measuring both FBS and PPBS. It also demonstrated a fair agreement with the automated analyzer in estimating blood glucose levels.