Method for preparing a glycated hemoglobin solution

Chemistry: analytical and immunological testing – Composition for standardization – calibration – simulation,... – Protein or peptide standard or control

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436 8, 436 10, 436 16, 436 66, 436 67, 436826, 356 42, G01N 3396

Patent

active

055893937

ABSTRACT:
The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

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