Test sensor reagent having cellulose polymers

• US 8,940,153 B2
• Filed: 11/13/2006
• Issued: 01/27/2015
• Est. Priority Date: 11/14/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Chu, Amy H., Edelbrock, Andrew J., Spradlin, Hope G.
• Primary Examiner(s): Hendricks, Keith
• Assistant Examiner(s): CARLSON, KOURTNEY SALZMAN
• Application Number:
  US12/083,952
• Publication Number:
  US 20090152128A1
• Time in Patent Office: 2,997 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 435/200
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/26 involving oxidoreductase

Abstract

A test sensor reagent for measuring the concentration of analytes in body fluids includes cellulose polymers for improving the stability of the test sensor and reducing the total assay time. The test sensor reagent also includes an enzyme, an electron transfer mediator and a rheological additive.

Claims

1. A test sensor reagent composition adapted to assist in determining an analyte concentration of a fluid sample, the reagent comprising an enzyme, an electron transfer mediator, a cellulose polymer and a rheological additive, wherein the rheological additive is smectite clay, wherein the test sensor reagent composition comprises from about 3.6 wt. % to about 6.0 wt. % of a hydroxyethyl cellulose polymer, from about 1 wt. % to about 4 wt. % of a glucose oxidase enzyme, from about 15 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 1.6 wt. % of the smectite clay.

2. The composition according to claim 1, wherein the cellulose polymer, rheological additive and the enzyme are present in a single layer.

3. The composition according to claim 1, wherein the reagent further comprises about 10 mMolar to about 500 mMolar of a citrate buffer.

4. A method of determining an analyte concentration of a fluid sample comprising the acts of:

providing an electrochemical test sensor adapted to assist in determining the analyte concentration, the electrochemical test sensor comprising a plurality of electrodes including a first electrode and a second electrode, a fluid receiving area and a test sensor reagent, the test sensor reagent composition comprising a cellulose polymer, a rheological additive, and an enzyme, the rheological additive is smectite clay, wherein the test sensor reagent composition comprises from about 3.6 wt. % to about 6.0 wt. % of a hydroxyethyl cellulose polymer, from about 1 wt. % to about 4 wt. % of a glucose oxidase enzyme, from about 15 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 1.6 wt. % of the smectite clay; and

determining the analyte concentration in an assay time of less than about 35 seconds.

5. The method according to claim 4, wherein the cellulose polymer, rheological additive and the enzyme are present in a single layer.

6. The method according to claim 4, wherein the total assay time is reduced to less than about 25 seconds.

7. A method of determining an analyte concentration of a fluid sample, the method comprising the acts of:

providing a fluid sample;

contacting a test sensor with the fluid sample, the fluid sample having at least one analyte;

contacting the fluid sample with a reagent composition comprising a cellulose polymer, a rheological additive and an enzyme, the rheological additive is smectite clay, wherein the test sensor reagent composition comprises from about 3.6 wt. % to about 6.0 wt. % of a hydroxyethyl cellulose polymer, from about 1 wt. % to about 4 wt. % of a glucose oxidase enzyme, from about 15 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 1.6 wt. % of the smectite clay;

providing an electrical signal indicative of the analyte in the fluid sample; and

determining the analyte using the electrical signal.

8. The method according to claim 7, wherein the analyte concentration is determined in less than about 35 seconds.

9. A method of determining an analyte concentration of a fluid sample, the method comprising the acts of:

providing the fluid sample;

contacting a test sensor with the fluid sample, the fluid sample having at least one analyte;

contacting the fluid sample with a reagent composition comprising a cellulose polymer, a rheological additive and an enzyme, the rheological additive is smectite clay, wherein the test sensor reagent composition comprises from about 1 wt. % to about 10 wt. % of a hydroxyethyl cellulose polymer, from about 0.5 wt. % to about 5 wt. % of a glucose oxidase enzyme, from about 1 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 3 wt. % of the smectite clay; and

determining the analyte concentration of the fluid sample.

10. The method according to claim 9, wherein the test sensor is an optical test sensor.

11. A test sensor reagent composition adapted to assist in determining an analyte concentration of a fluid sample, the reagent comprising an enzyme, an electron transfer mediator, a cellulose polymer and a rheological additive, wherein the cellulose polymer, the rheological additive and the enzyme are present in a single layer, and wherein the rheological additive is a smectite clay, wherein the test sensor reagent composition comprises from about 1 wt. % to about 10 wt. % of a hydroxyethyl cellulose polymer, from about 0.5 wt. % to about 5 wt. % of a glucose oxidase enzyme, from about 1 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 3 wt. % of the smectite clay, wherein the hydroxyethyl cellulose polymer has a molecular weight from about 25,000 to about 2,000,000.

12. The composition according to claim 11, wherein the reagent composition comprises from about 0.2 wt. % to about 1.6 wt. % of the smectite clay.

13. A test sensor reagent composition adapted to assist in determining an analyte concentration of a fluid sample, the reagent comprising an enzyme, an electron transfer mediator, a cellulose polymer and a rheological additive, wherein the test sensor reagent composition comprises from about 1 wt. % to about 10 wt. % of a hydroxyethyl cellulose polymer, from about 0.5 wt. % to about 5 wt. % of a glucose oxidase enzyme, from about 1 wt. % to about 20 wt. % of a ferricyanide mediator and from about 0.2 wt. % to about 3 wt. % of the rheological additive, wherein the hydroxyethyl cellulose polymer has a molecular weight from about 25,000 to about 2,000,000.

14. The composition according to claim 13 wherein the reagent composition comprises from about 0.2 wt. % to about 1.6 wt. % of the rheological additive.

15. The composition according to claim 13 wherein the cellulose polymer, the rheological additive and the enzyme are present in a single layer.