ArticlePractical laboratory medicine2026
Evaluation of a point-of-care testing platform against a laboratory HbA1c measurement method in a South African tertiary-level diabetes clinic.
Article in Practical laboratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Diabetes mellitus (DM) is a major global issue, with a prevalence of 11.1%. In Africa, South Africa is recognized as having one of the highest prevalences. Limited access to timely glycated haemoglobin (HbA1c) testing may delay treatment adjustments for diabetic patients. Point-of-care (POC) analysers provide faster results, potentially enhancing diabetes management. This study aimed to evaluate the performance of a POC device compared to a laboratory-based method, including the effect of potentially interfering haemoglobin (Hb) variants. Methods: HbA1c was measured in whole blood and capillary samples from 63 diabetic patients using the Finecare™ HbA1c POC device and compared to the Bio-Rad Variant II, a laboratory method utilising ion-exchange high-performance liquid chromatography (HPLC). 43 whole blood samples identified with Hb variants from routine laboratory HPLC analysis were also assessed on the POC device. Results: The POC device demonstrated a strong correlation with HPLC for both capillary (r = 0.94, 95% CI 0.90-0.96) and whole blood samples (r = 0.94, 95% CI 0.91-0.97). Mean bias was 1.3% (95% CI -1.2-3.8) for capillary vs. HPLC, and 4.5% (95% CI 2.1-6.9) for whole blood vs. HPLC. However, POC HbA1c in samples with Hb variants showed poor correlation with HPLC (r = 0.60, 95%CI 0.37-0.77) and a mean bias of -2.8% (95%CI -7.2-1.5). Conclusion: The Finecare™ HbA1c POC device performed acceptably for both capillary and whole blood samples, comparable to the HPLC method. We recommend capillary samples for routine monitoring but advise caution in populations with a high prevalence of Hb variants.
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