Stable diagnostic reagent

• US 5,627,075 A
• Filed: 03/20/1996
• Issued: 05/06/1997
• Est. Priority Date: 06/21/1993
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation (Roche Holding AG)
• Inventors: Bateson, Joseph E.
• Primary Examiner(s): Redding, David A.
• Application Number:
  US08/619,118
• Time in Patent Office: 412 Days
• Field of Search: 436/8, 436/14, 436/18, 436/95, 436/176, 435/14, 435/28
• US Class Current: 436/8
• CPC Class Codes: C12N 9/0006 acting on CH-OH groups as donors (1.1)
• CPC Class Codes: C12N 9/96 Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

The inclusion of succinic acid or a salt thereof to stabilize compositions that include glucose oxidase and/or ferricyanide. Typically, the succinic acid or succinic acid salt is included in a diagnostic reagent utilized in test strips or test solutions useful for the analysis of glucose from a fluid sample.

Claims

1. A process for stabilizing a diagnostic reagent composition comprising glucose oxidase, the process comprising the step of

adding succinic acid or a salt thereof to the composition in an amount effective to stabilize the composition.

2. A process for stabilizing a diagnostic reagent composition comprising ferricyanide, the process comprising the step of

adding succinic acid or a salt thereof to the composition in an amount effective to stabilize the composition.

3. A process for stabilizing a diagnostic reagent composition comprising glucose oxidase and ferricyanide, the process comprising the step of

adding succinic acid or a salt thereof to the composition in an amount effective to stabilize the composition.

4. The process of claim 3, wherein the concentration of succinic acid or a salt thereof is from about 181/2 millimolar to about 55 millimolar.

5. The process of claim 3, wherein the concentration of succinic acid or a salt thereof is about 37 millimolar.

6. The process of claim 4, wherein the succinic acid or a salt thereof is disodium succinate.

7. The process of claim 4, wherein the composition includes water, a dispersant and crystallization inhibitor in sufficient amount to form a slurry, and a buffer in sufficient amount to provide and maintain a pH at which glucose oxidase will catalyze the oxidation of glucose.

8. The process of claim 7, wherein the composition further includes a surfactant in sufficient amount to aid in rehydrating the composition with an aqueous sample after the slurry has been dried to form a dry reagent useful for the analysis of glucose in the sample.

9. The process of claim 8, wherein the succinic acid or a salt thereof is about 37 millimolar.

10. A diagnostic reagent composition, comprising

glucose oxidase and ferricyanide in an aqueous medium, or in a dried matrix, the ferricyanide being present in an amount effective to function as a redox mediator in the catalytic oxidation of glucose;

and

succinic acid or a salt thereof in a concentration of about 18.5 millimolar to about 55 millimolar to stabilize the composition.

11. The composition of claim 10, further comprising:

a buffer in sufficient amount to provide and maintain a pH at which glucose oxidase will catalyze the oxidation of glucose.

12. The composition of claim 11, wherein the glucose oxidase and ferricyanide is in the dried matrix and the composition further comprises a surfactant in sufficient amount to aid in rehydrating the composition when an aqueous sample is added to the dried matrix.

13. The composition of claim 11, wherein the glucose oxidase and ferricyanide is in the aqueous medium and wherein the aqueous medium is formed by combining water and a dispersant and crystallization inhibitor.

14. The composition of claim 13, further comprising:

a surfactant in sufficient amount to aid in rehydrating the composition with an aqueous sample after the composition has been dried to form a dry reagent useful for the analysis of glucose in the aqueous sample.

15. The composition of claim 13, wherein the concentration of succinic acid or a salt thereof is about 37 millimolar.

16. The composition of claim 15, wherein disodium succinate is used to form the composition.

17. The composition of claim 14, wherein disodium succinate is used to form the composition.

18. A method for forming a stabilized rehydratable diagnostic reagent composition comprising glucose oxidase and ferricyanide, the method comprising the steps of

forming an aqueous solution comprising glucose oxidase, ferricyanide in an amount sufficient to function as a redox mediator in the catalytic oxidation of glucose by the glucose oxidase, a surfactant, and succinic acid or a salt thereof in an amount sufficient to stabilize the composition, and

drying the solution to remove at least about 90% by weight water to form a stabilized dry reagent composition.

19. The process of claim 18 wherein a dispersant is added to the aqueous solution to form a slurry.

20. The process of claim 18 wherein disodium succinate is used to form the aqueous solution.