US5206144A
Expired / Lapsed
US
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Determination of glycated (glycosylated) hemoglobin in blood
Assignee: Dako Denmark ApS
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Filing: 1990-10-30
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Granted: 1993-04-27
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Expires: 2010-10-30
Abstract
Abstract The concentration of glycated hemoglobin, HbA1c, 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 HbA1c, can be used for the determination of HbA1c 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.
Inventors
- 👤 Jesper Zeuthen
- 👤 Annette Prento
- 👤 Viggo Kruse
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 18:15
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/72; G01N33/721; G01N33/723; C; C07; C07K; C07K16/00; C07K16/18
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
102 words
A method for the determination of glycated hemoglobin (HbA 1c ) in a sample comprising a mixture of HbA 1c and non-glycated hemoglobin (HbA 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 1c relative to HbA o when said HbA 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.
Claim 2
Independent Claim
102 words
A method for the determination of glycated hemoglobin (HbA 1c ) in a sample comprising a mixture of HbA 1c and non-glycated hemoglobin (HbA 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 1c relative to HbA o when said HbA 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.
Claim 3
Independent Claim
97 words
A method for the determination of glycated hemoglobin (HbA 1c ) in a sample comprising a mixture of HbA 1c and non-glycated hemoglobin (HbA 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 1c relative to HbA o when said HbA 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.
Claim 4
Independent Claim
97 words
A method for the determination of glycated hemoglobin (HbA 1c ) in a sample comprising a mixture of HbA 1c and non-glycated hemoglobin (HbA 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 1c relative to HbA o when said HbA 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.
Claim 5
Dependent Claim
22 words
The method of claim 1 or 2 wherein said antibody is produced by the hybridoma cell line having the ECACC designation 85020101.
Claim 6
Dependent Claim
16 words
The method of claim 1 or 2 wherein said hemoglobin is insolubilized on a multiwell plate.
Claim 7
Dependent Claim
14 words
The method of claim 1 or 2 wherein said monoclonal antibody is detectably labeled.
Claim 8
Dependent Claim
15 words
The method of claim 5, wherein said detectable label is an enzyme or a radiolabel.
Claim 9
Dependent Claim
24 words
The method of claim 1 or 2 wherein said bound monoclonal antibody is measured by adding thereto a labeled second antibody with specificity therefor.
Claim 10
Dependent Claim
15 words
The method of claim 1 or 2 wherein said monoclonal antibody is attached to biotin.
Claim 11
Dependent Claim
20 words
The method of claim 8, wherein said attached monoclonal antibody is detected by adding thereto horseradish peroxidase conjugated to avidin.
Claim 12
Dependent Claim
86 words
A kit for the determination of glycated human hemoglobin (HbA 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 1c relative to non-glycated hemoglobin (HbA o ), when said HbA1c is insolubilized on a solid phase; and (C) at least a second container containing HbA 1c at a predetermined concentration.
Claim 13
Dependent Claim
86 words
A kit for the determination of glycated human hemoglobin (HbA 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 1c relative to non-glycated hemoglobin (HbA o ), when said HbA1c is insolubilized on a solid phase; and (C) at least a second container containing HbA 1c at a predetermined concentration.
Claim 14
Dependent Claim
12 words
The kit of claim 10, wherein said monoclonal antibody is detectably labeled.
Claim 15
Dependent Claim
15 words
The kit of claim 11, wherein said detectable label is an enzyme or a radiolabel.
Claim 16
Dependent Claim
29 words
The kit of claim 10, which contains a third container containing HbA 1c at a predetermined concentration which is different from that of HbA 1c in said second container.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-04-26 | 1996-10-26 | 1997-04-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-04-26 | 2000-10-26 | 2001-04-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-04-26 | 2004-10-26 | 2005-04-27 | $7700.00 | Window Closed / Lapsed |