This study aimed to assess the diagnostic performance of a point-of-care (POC) glycated hemoglobin (HbA1c) device in the Indian population against the standard laboratory (high-performance liquid chromatography {HPLC}) method for the effective management of diabetes in India. This study on the diagnostic accuracy of a POC HbA1c device involved 121 participants. These participants were categorized into two groups according to their HbA1c levels - one group with HbA1c values below 6.5% and another group with HbA1c values equal to or greater than 6.5%. The HbA1c levels in enrolled participants were estimated using both the POC device (HemoCueHbA1c 501; Ängelholm, Sweden: HemoCue AB) and the standard HPLC-based method. The level of agreement and concordance between the two test results were assessed by the Bland-Altman plot and Lin's concordance correlation coefficient. Sensitivity, specificity, diagnostic accuracy, positive likelihood, and negative likelihood ratios of POC-HbA1c device were assessed with a 6.5% HbA1c cut-off. The mean HbA1c values obtained by the two methods showed no statistically significant difference with a minimum effect size (Cohen's d = 0.035), indicating there was a negligible difference between these methods. The Bland-Altman plot revealed that most values were within acceptable limits (95% CI: -0.5 to 0.7) and Lin's concordance correlation coefficient showed strong agreement (p < 0.0001).The POC-HbA1c device demonstrated an area under the curve (AUC) of 0.991 (95% CI: 0.953-1.000) with sensitivity, specificity, diagnostic accuracy, positive likelihood, and negative likelihood ratios of 93.62%, 97.30%, 95.87%, 34.64 and 0.07, respectively, compared to the standard diagnostic assay. The diagnostic accuracy, sensitivity, and specificity demonstrated by the POC-HbA1c device to the standard HPLC method offers a viable and practical solution for diabetes management in India. Its ability to provide rapid and reliable results at the point of care can improve patient outcomes, reduce healthcare costs, and enhance access to diabetes care, especially in primary care, remote areas, and resource-limited settings of developing countries like India.
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