Point-of-care detection of glycated hemoglobin using a novel dry chemistry-based electrochemiluminescence device

As a good biomarker to reflect the average level of blood glucose, glycated hemoglobin (HbA1c) is mainly used for long-term glycemic monitoring and risk assessment of complications in diabetic patients. Previous analysis methods for HbA1c usually require complex pretreatment processes and large-scale biochemical analyzers, which makes it difficult to realize the point-of-care testing (POCT) of HbA1c. In this work, we have proposed a three-electrode dry chemistry-based electrochemiluminescence (ECL) biosensor and its self-contained automatic ECL analyzer. In this enzymatic biosensor, fructosyl amino-caid oxidase (FAOD) reacts with the hydrolysis product of HbA1c, and the produced hydrogen peroxide further reacts with luminol under the appropriate driving voltage, generating photons to realize the quantitative detection of HbA1c. Under optimized conditions, the biosensors have a good linear response to different concentrations of fructosyl valine (FV) ranging from 0.05 to 2 mM, with a limit of detection of 2 μM. The within-batch variation is less than 15%, and the biosensors still have 78% of the initial response after the accelerated aging test of 36 h at 37 °C. Furthermore, the recoveries for different concentrations of samples in whole blood were within 92.3-99.7%. These results illustrate that the proposed method has the potential for use in POCT of HbA1c.