Quantitative, single-step dual measurement of hemoglobin A1c and total hemoglobin in human whole blood using a gold sandwich immunochromatographic assay for personalized medicine

摘要

We describe a gold nanoparticle-based sandwich immunoassay for the dual detection and measurementudof hemoglobin A1c (HbA1c) and total hemoglobin in the whole blood (without pretreatment) in a singleudstep for personalized medicine. The optimized antibody-functionalized gold nanoparticles immunoreactudsimultaneously with HbA1c and total hemoglobin to form a sandwich at distinctive test lines to transduceudvisible signals. The applicability of this method as a personal management tool was demonstratedudby establishing a calibration curve to relate % HbA1c, a useful value for type 2 diabetes management, toudthe signal ratio of captured HbA1c to all other forms of hemoglobin. The platform showed excellentudselectivity (100%) toward HbA1c at distinctive test lines when challenged with HbA0, glycated HbA0 andudHbA2. The reproducibility of the measurement was good (6.02%) owing to the dual measurement ofudHbA1c and total hemoglobin. A blood sample stability test revealed that the quantitative measurement ofud% HbA1c was consistent and no false-positive results were detected. Also, this method distinguished theudblood sample with elevated HbF from the normal samples and the variants. The findings of this studyudhighlight the potential of a lateral flow immunosensor as a simple, inexpensive, consistent, and convenientudstrategy for the dual measurement of HbA1c and total Hb to provide useful % HbA1c values forudbetter on-site diabetes care.