Analysis element and method for analyzing glycated hemoglobin content ratio

摘要

An analysis element for analyzing both amounts of glycated hemoglobin and total hemoglobin in an aqueous liquid sample to determine glycated hemoglobin content ratio in the sample. The element comprises a substrate layer for receiving a reaction mixture after the completion of an immunological reaction between the glycated hemoglobin in the sample and an enzyme-labelled antibody against the glycated hemoglobin, and a reagent layer. The substrate layer contains a non-diffusible substrate which forms a diffusible material in the presence of the enzyme of the enzyme-labelled antibody, the activity of the enzyme being effected relative to the steric hindrance due to the immunological reaction. The reagent layer contains a reagent composition for reacting with the diffusible material to form a dye detectable colorimetrically in a wavelength range which is not effected by an absorption spectrum of the hemoglobin. The total hemoglobin retained in the substrate layer and the dye formed in the reagent layer are colorimetrically analyzed separately, and the glycated hemoglobin content ratio is calculated from respective values. An analysis method using this analysis element is also provided.