Determination of glycated (glycosylated) hemoglobin in blood
AssigneeNovo Industri A/S
InventorsJesper Zeuthen, Annette Prento, Viggo Kruse
Life of this patent
Estimating the term…
Abstract
The concentration of glycated hemoglobin, HbA.sub.1c, in hemoglobin from diabetic patients is regarded as a useful means of assessing the adequacy of diabetes control. This invention comprises a monoclonal antibody which, due to its specific binding of HbA.sub.1c, can be used for the determination of HbA.sub.1c in the absence of prior denaturation, in blood samples by such analytical methods as radioimmuno assay or enzyme-linked immunosorbent assay. The invention also comprises hybridoma cell lines which produce monoclonal antibodies of the invention.
Claims13
A method for the determination of glycated hemoglobin (HbA.sub.1c) in a sample comprising a mixture of HbA.sub.1c and non-glycated hemoglobin (HbA.sub.o) in the absence of prior denaturation, which comprises:
- (A) insolubilizing hemoglobin in said sample on a solid phase;
- (B) contacting said insolubilized hemoglobin with a murine monoclonal antibody which has binding selectivity for HbA.sub.1c relative to HbA.sub.o when said HbA.sub.1c is insolubilized on a solid phase;
- (C) measuring the amount of bound monoclonal antibody;
- and
- (D) relating said measured amount of bound monoclonal antibody to the amount of glycated hemoglobin in said sample.
A method for the determination of glycated hemoglobin (HbA.sub.1c) in a sample comprising a mixture of HbA.sub.1c and non-glycated hemoglobin (HbA.sub.o), consisting essentially of:
- (A) insolubilizing hemoglobin in said sample on a solid phase;
- (B) contacting said insolubilized hemoglobin with a murine monoclonal antibody which has binding selectivity for HbA.sub.1c relative to HbA.sub.o when said HbA.sub.1c is insolubilized on a solid phase;
- (C) measuring the amount of bound monoclonal antibody;
- and
- (C) relating said measured amount of bound monoclonal antibody to the amount of glycated hemoglobin in said sample.
A kit for the determination of glycated human hemoglobin (HbA.sub.1c), which kit comprises:
- (A) a carrier being compartmentalized to receive in close confinement therein two or more containers;
- (B) a first container containing a monoclonal antibody produced by the hybridoma cell line having the designation ECACC 85020101 and having binding selectivity of HbA.sub.1c relative to non-glycated hemoglobin (HbA.sub.o), when said HbA1c is insolubilized on a solid phase;
- and
- (C) at least a second container containing HbA.sub.1c at a predetermined concentration.
Dependencies are inferred from the claim text.