Comparison of point-of-care HbA1c devices with laboratory HPLC methods: A systematic review and meta-analysis.

Abstract

Hemoglobin A1c (HbA1c), also known as glycated hemoglobin, is a cornerstone biomarker for diagnosing and monitoring diabetes. While high-performance liquid chromatography (HPLC) is the reference standard, point-of-care (POC) devices are increasingly used due to convenience and rapid results. However, concerns remain about their analytical accuracy. This systematic review and meta-analysis evaluated the agreement between POC HbA1c devices and laboratory HPLC-based methods. A total of 11 studies involving 1,593 participants and 3,285 paired measurements were included. The pooled mean difference between POC and HPLC was 0.01% [95% confidence interval (CI), -0.08 to 0.11%; 95% prediction interval (PI), -0.443 to 0.471%; P=0.779], well within the clinically acceptable margin of ±0.5%. However, substantial heterogeneity was observed and extensive subgroup analyses across device model, analytical principle, and study characteristics did not fully explain this variability. Notably, some platforms, such as lateral flow immunoassays, exhibited larger biases approaching thresholds relevant to clinical decision-making. Although most POC devices demonstrated acceptable agreement, results highlight the importance of careful validation and interpretation. Future research should prioritize standardized protocols, comparative studies across platforms, and assessment in real-world decentralized settings to enhance confidence in POC HbA1c measurement.