Abbott Laboratories Corporation

Barbara J England

John M Ramp

Michael D Fiechtner

Mary J Annino

Louis Saldivar, Jr

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.

Methods and reagents for the rapid determination of glycated hemoglobin

Method for preparing a glycated hemoglobin solution

A stabilized anoxic diagnostic reagent solution comprising an oxygen labile reagent, glucose oxidase, glucose, a hydrogen donor, sterile membrane fragments derived from bacteria having membranes containing an oxygen transfer system, and a reagent binding agent. The stabilized reagent has at least six months storage stability at 2.degree.-8.degree. C. and open vial stability of at least three weeks.

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Milwaukee, WI, United States of America

Barbara J England