Article and method for measuring glucose level in body fluids

• US 4,330,299 A
• Filed: 03/09/1981
• Issued: 05/18/1982
• Est. Priority Date: 03/09/1981
• Status: Expired due to Fees

• Current Assignee: Evreka, Inc.
• Original Assignee: Evreka, Inc.
• Inventors: Cerami, Anthony
• Primary Examiner(s): Marantz, Sidney
• Application Number:
  US06/241,991
• Time in Patent Office: 435 Days
• Field of Search: 23/230 B, 23/901, 422/56, 422/57, 422/61, 435/14, 435/805, 252/408
• US Class Current: 436/95
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method for measuring the level of glucose in animal body fluids such as blood and urine, comprises contacting the body fluid with a glucose indicator comprising a reversible complex of a carbohydrate component, a binding macromolecular component, and an indicator element bound to one of the components, and maintaining the body fluid in contact with the indicator for a period of time sufficient to permit any glucose present in the body fluid to displace the carbohydrate component in the complex, and to thereby release the indicator element to signify the presence of glucose. Preferably, the macromolecular component comprises one or more lectins, and the carbohydrate component may be one or more of the sugars for which testing is desired. The indicator element may be a dye or a color-forming radical, associated with either the lectin or the carbohydrate.

The glucose indicator may be prepared in strip form with either the lectin or the carbohydrate bound to an inert, insoluble substrate provided in kit form with a color chart keyed to identify specific sugars or concentrations thereof in the body fluid.

Claims

1. A method for measuring the level of glucose in animal body fluids comprising placing a sample of said body fluid in contact with a glucose indicator, said indicator comprising a reversible complex of a carbohydrate component, a binding macromolecular component and an indicator element associated with one of said components, maintaining said body fluid in contact with said glucose indicator for a period of time sufficient for any glucose present in said body fluid to displace said carbohydrate component in a complex with said binding macromolecular component, and for said indicator element to be released thereby to signify the presence and level of said glucose.

2. The method of claim 1 wherein said glucose indicator is provided in strip form.

3. The method of claim 2 including removing excess body fluid from said indicator after said indicator element is released.

4. The method of claims 1 or 2 wherein said binding macromolecular component comprises a binding protein, said carbohydrate component comprises a sugar selected from the group consisting of monosaccharides, oligosaccharides and mixtures thereof, and said indicator element is selected from the group consisting of color forming materials capable of forming precipitates, and mixtures thereof.

5. The method of claim 4 wherein said binding macromolecular component is fixedly attached to an inert, insoluble substance, said carbohydrate component is bound thereto in said reversible complex, and said indicator element is bonded to said carbohydrate component.

6. The method of claim 4 including the further step of comparing the activity of said indicator element after release with the results of comparative tests of said indicator element associated with given levels of said glucose.

7. The method of claim 6 wherein said indicator element is a plurality of different color forming materials, and said comparative tests are disposed on said color forming materials with specific concentrations of said glucose.

8. A glucose indicator for use in measuring the level of glucose in animal body fluids comprising,

a reversible complex of a carbohydrate component, a binding macromolecular component, and a indicator element associated with one of said components,

said reversible complex adapted to dissociate in the presence of glucose in said body fluid, whereby said glucose forms a complex with said macromolecular component, and said indicator element is released and signifies the presence of said glucose.

9. The indicator of claim 8 wherein said carbohydrate component comprises a sugar selected from the group consisting of monosaccharides, oligosaccharides, and mixtures thereof,

said binding macromolecular component is selected from the group consisting of natural binding proteins, synthetic binding proteins and mixtures thereof, and

said indicator element is selected from the group consisting of color forming materials, precipitate forming materials and mixtures thereof.

10. The indicator of claim 9 wherein said binding macromolecular componet comprises a natural binding protein, and said indicator element comprises a color-forming material, said color-forming material selected from the group consisting of dyes, color forming radicals and mixtures thereof.

11. The indicator of claim 10 wherein said binding macromolecular component comprises one or more lectins, and said carbohydrate component comprises monosaccharides and oligosaccharides containing a material selected from the group consisting of glucose, mannose and mixtures thereof.

12. The indicator of claim 11 wherein said binding macromolecular component comprises Concanavalin A, and said oligosaccharides contain up to about 6 monosaccharide units.

13. The indicator of claims 8,9,10,11 or 12 wherein said reversible complex is affixed to an inert, insoluble substrate.

14. The indicator of claim 13 wherein said substrate is prepared from a material selected from the group consisting of natural and synthetic resins, ceramic materials, and mixtures thereof.

15. The indicator of claim 13 wherein said substrate is prepared from a material selected from the group consisting of cellulose, vinyl resins, glass and mixtures thereof.

16. The indicator of claim 13 wherein said binding macromolecular component is fixedly attached to said substrate and reversibly bound to said carbohydrate component, and said indicator element is bound to said carbohydrate component.

17. The indicator of claim 13 wherein said carbohydrate component is fixedly attached to said substrate and reversibly bound to said binding macromolecular component, and said indicator element is bound to said binding macromolecular component.

18. The indicator of claim 13, wherein said substrate is in the form of a strip.

19. The indicator of claim 13 wherein said substrate bearing said reversible complex is enclosed within a membrane permeable to said body fluid and adapted to permit the passage therethrough of said carbohydrate component and said glucose.

20. A kit for measuring the level of glucose in animal body fluid comprising the glucose indicator of claim 13 in combination with comparative test results of said indicator associating the activity of said indicator element with specific levels of said glucose.

21. The kit of claim 20 wherein said carbohydrate component comprises a plurality of different oligosaccharides, each oligosaccharide associated with a color-forming material that gives a color reaction different from that of the remaining color forming materials, and said comparative test results comprise a color chart relating specific colors to particular levels of glucose concentration.