A Comparative Evaluation of Point-of-Care and Laboratory HbA1c Testing in Diabetes Care: An Indian Perspective
Open accessAbstract
AIM: 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. METHODS: 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 (HemoCue HbA1c 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. RESULTS: 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. CONCLUSIONS: 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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The systematic review and meta-analysis included 11 studies involving 1,593 participants and 3,285 paired HbA1c measurements comparing POC devices with reference HPLC-based laboratory methods.
“A total of 11 studies involving 1,593 participants and 3,285 paired measurements were included.”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [33]
The Materials and methods section describes a single diagnostic-accuracy study in Bhopal, not a systematic review or meta-analysis. The Results section reports 121 participants whose HbA1c was measured by both POC and HPLC methods, contrary to the attributed totals of 11 studies, 1,593 participants, and 3,285 paired measurements. The indexed passages provide no page numbers. (LLM, conf=0.90)
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Experimental — accuracy not yet measuredSome included studies evaluated POC devices using venous blood instead of capillary fingerstick samples, despite the devices being designed for the latter.
“From a practical standpoint, some studies evaluated POC devices using venous blood instead of capillary fingerstick samples, despite the devices being designed for the latter (30,33).”
From Comparison of point‑of‑care HbA1c devices with laboratory HPLC methods: A systematic review and meta‑analysis (2026) · cites this paper as [33]
The Discussion says this study used venous blood for both the POC and laboratory HbA1c tests, whereas most previous studies used capillary blood for POC testing. It does not establish that the device was designed specifically for capillary fingerstick samples. (LLM, conf=0.84)
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“From a practical standpoint, some studies evaluated POC devices using venous blood instead of capillary finger‑ stick samples, despite the devices being designed for the latter (30,33).”
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- Authors
- Rathod, L., Khan, S., Shubham, S., Bisne, N., Singh, S., Kumar, M., Tiwari, R., & Sarma, D. K.
- Affiliations
- Rajiv Gandhi Technical University (IN)
- Indian Council of Medical Research (IN)
- Corresponding author
- Sarma, Devojit K
- Venue
- Cureus
- Published
- 2024-09-22
- Volume
- 16
- Issue
- 9
- Pages
- e69956-e69956
- ISSN
- 2168-8184 (ISSN-L)
- PMC
- PMC11496592
- OpenAlex
- W4402723009
- Cited by
- 1
- References
- 21
- Citations by year
- 2025: 1
- FWCI
- 0.33
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by
- Locations
- Cureus (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- point-of-care testing, HbA1c, diabetes management, HPLC, diagnostic accuracy, measurement agreement, Indian population, diabetes screening, glycemic control monitoring, sensitivity and specificity, likelihood ratios, cost-effectiveness
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