A Rapid Test Strip for Diagnosing Glycosylated Hemoglobin (HbA1c) Based on Fluorescent Affinity Immunochromatography

In this research, we developed a rapid and easy-to-operate point-of-care testing (POCT) strip based on fluorescent affinity immunochromatography to quantitatively determine HbA1c concentrations in whole blood. This assay, based on a sandwich method performed on test strips, effectively utilized the principle of an affinity chromatography column, which was commonly used in the detection of HbA1c, and the technology of traditional fluorescence immunochromatographic test strips (FICTS) were combined. In our test strips, the test line of traditional FICTS was transformed into the region of affinity chromatography, while improving the linearity and reducing the interference of the precursor of HbA1c and hemoglobin variants. The test strips could quantitatively detect HbA1c over a wide range (3 - 13.8%) with excellent linearity (R² > 0.99), and the assay accuracy was demonstrated by comparing with high-performance liquid chromatography (HPLC) (R² > 0.95). The simple, rapid, effective and quantitative strips will provide a novel method for the detection of HbA1c in clinical diagnosis.