A REAGENT FORMULATION USING RUTHENIUM HEXAMINE AS A MEDIATOR FOR ELECTROCHEMICAL TEST STRIPS

• US 20090280551A1
• Filed: 10/05/2007
• Published: 11/12/2009
• Est. Priority Date: 10/05/2006
• Status: Abandoned Application

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Mills, Leanne, Leach, Christopher Philip, Cardosi, Marco F.
• Application Number:
  US12/305,361
• Publication Number:
  US 20090280551A1
• Time in Patent Office: Days
• US Class Current: 435/190
• CPC Class Codes: C12Q 1/004 mediator-assisted

Abstract

Described herein are various embodiments of a test strip, which may be capable of measuring an analyte. The test strip may include a working electrode and a reference electrode where the reagent formulation is disposed on the working electrode. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The reagent formulation may be coated onto the test strip. The reagent formulation includes an enzyme, a ruthenium hexamine mediator, and a solution for dissolving the enzyme and the ruthenium hexamine mediator. The ruthenium hexamine has a concentration range from about 15% to about 20% (weight of mediator/volume) of solution. The enzyme may be either glucose oxidase and glucose dehydrogenase.

Claims

1. A formulation for coating a test strip, the formulation comprising:

an enzyme;

a ruthenium hexamine mediator; and

a solution that dissolves the enzyme and the ruthenium hexamine mediator and in which the ruthenium hexamine comprises a concentration range from about 15% to about 20% of weight.

2. The formulation of claim 1, wherein the enzyme is a material selected from the group consisting of essentially glucose oxidase and glucose dehydrogenase.

3. The formulation of claim 1, wherein the enzyme is glucose oxidase and the glucose oxidase has an activity range from about 1500 units/mL to about 8000 units/mL.

4. The formulation of claim 1, wherein the solution is a buffer selected from the group consisting of phosphate, citrate, and citraconate.

5. The formulation of claim 4, wherein the buffer is phosphate and has a pH of about 7.

6. The formulation of claim 1, wherein the test strip comprises a working electrode and a reference electrode, and the formulation is disposed on the working electrode

7. The formulation of claim 1, wherein the formulation further comprises a filler having hydrophilic and hydrophobic domains.

8. The formulation of claim 7, wherein the filler comprises silica.

9. The formulation of claim 7, wherein the formulation is disposed on the working electrode using a process of screen printing, wherein the screen has a plurality of interwoven threads, the plurality of interwoven threads forming a plurality of open rectangular spaces for allowing the formulation to pass therethrough, the plurality of interwoven threads having a thread spacing and a thread diameter, wherein the thread spacing ranges from about 90 threads per centimeter to about 120 threads per centimeter and the thread diameter may range from about 30 microns to about 50 microns.

10. A test strip comprising:

a generally planar substrate that extends from a first end to a second end;

first and second electrodes disposed on the substrate proximate one of the first and second ends; and

a reagent layer having ruthenium hexamine trichloride in a buffer solution with a concentration range from about 15% to about 20% (weight/volume) such that the test strip shows essentially no increase in bias to reference when a blood sample is tested at about 400 millivolts after storage for seven days at 40 degrees Celsius at 75% relative humidity.

13. The test strip of claim 10, in which the enzyme is a material selected from the group consisting of essentially glucose oxidase and glucose dehydrogenase.

14. The test strip of claim 10, in which the enzyme is glucose oxidase and the glucose oxidase has an activity range from about 1500 units/mL to about 8000 units/mL.

15. The test strip of claim 10, in which the solution is a buffer selected from the group consisting of phosphate, citrate, and citraconate.

16. The formulation of claim 15, wherein the buffer is phosphate and has a pH of about 7.

17. The formulation of claim 10, wherein the test strip comprises a working electrode and a reference electrode, and the formulation is disposed on the working electrode

18. The formulation of claim 10, wherein the formulation further comprises a filler having hydrophilic and hydrophobic domains.

19. The formulation of claim 18, wherein the filler comprises a silica.

11. A test strip comprising:

a generally planar substrate that extends from a first end to a second end;

first and second electrodes disposed on the substrate proximate one of the first and second ends; and

a reagent layer having ruthenium hexamine Trichloride in a buffer solution with a concentration range from about 15% to about 20% (weight/volume) such that the test strip shows essentially no increase in bias to reference when tested at about 400 millivolts with blood glucose sample of about 70 mg/dL with uric acid concentration of about 0 mg/dL to about 20 mg/dL.

12. A test strip comprising:

a generally planar substrate that extends from a first end to a second end;

first and second electrodes disposed on the substrate proximate one of the first and second ends; and

a reagent layer having an enzyme and ruthenium hexamine Trichloride in a buffer solution with a concentration range from about 15% to about 20% (weight/volume) such that the test strip shows essentially no increase in bias to reference when tested at about 400 millivolts with blood glucose sample of about 70 mg/dL with gentisic acid concentration from about 0 mg/dL to about 50 mg/dL.