Method of correcting for oxygen effect on test sensors

• US 9,534,244 B2
• Filed: 11/22/2011
• Issued: 01/03/2017
• Est. Priority Date: 04/10/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Lin, Jing
• Primary Examiner(s): RUFO, LOUIS J
• Application Number:
  US13/302,325
• Publication Number:
  US 20120067743A1
• Time in Patent Office: 1,869 Days
• Field of Search: 204/403.14, 204/403.04
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

An electrochemical test sensor is adapted to measure glucose and correct for the oxygen effect in a fluid sample. The test sensor comprises a base, first and second working electrodes, and a counter electrode. The first working electrode includes glucose oxidase, a mediator and peroxidase. The second working electrode includes glucose oxidase and the mediator. The first working electrode, the second working electrode and the counter electrode are located on the base. In other embodiments, an electrochemical test sensor is adapted to measure cholesterol, lactate, pyruvate or xanthine and correct for the oxygen effect in a fluid sample.

Claims

1. A method for correcting the oxygen effect in determining the concentration of glucose in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, and a counter electrode, the first working electrode including glucose oxidase, an oxidized form of a mediator and peroxidase, the second working electrode including glucose oxidase and the oxidized form of the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid on the test sensor;

measuring a first current from the first working electrode from the reduced form of the mediator;

measuring a second current from the second working electrode from the reduced form of the mediator; and

determining the concentration of glucose and correcting for the oxygen effect by using the first current measurement and the second current measurement.

2. The method of claim 1, wherein the fluid is blood.

3. The method of claim 1, wherein the mediator is a ferricyanide derivative.

4. The method of claim 3, wherein the ferricyanide derivative is potassium ferricyanide.

5. The method of claim 1, wherein the mediator is a ruthenium (III) derivative or a ferricium derivative.

6. The method of claim 1, wherein the mediator is an inorganic mediator.

7. The method of claim 1, wherein the test sensor further includes a lid, the base and the lid assisting in forming one generally flat channel with a test sensor opening, wherein placing the fluid on the test sensor includes placing the fluid into the channel via the test sensor opening and further including contacting the fluid with the first working electrode and the second working electrode in the generally flat channel and wherein the lid and the base are attached via an adhesive.

8. The method of claim 1, wherein the test sensor further includes a lid, the base and the lid assisting in forming one generally flat channel with a test sensor opening, wherein placing the fluid on the test sensor includes placing the fluid into the channel via the test sensor opening and further including contacting the fluid with the first working electrode and the second working electrode in the generally flat channel and wherein the lid and the base are attached via heat-sealing.

9. The method of claim 1, wherein the test sensor further includes a lid and a spacer, the spacer being located between the base and the lid, the base and the lid assisting in forming one generally flat channel with a test sensor opening, wherein placing the fluid on the test sensor includes placing the fluid into the channel via the test sensor opening and further including contacting the fluid with the first working electrode and the second working electrode in the generally flat channel.

10. A method for correcting the oxygen effect in determining the concentration of glucose in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, and a counter electrode, the first working electrode including glucose oxidase, an oxidized form of mediator and peroxidase, the second working electrode including glucose oxidase and the oxidized form of the mediator in the absence of the peroxidase, the first working electrode, the second working electrode and the counter electrode being adjacent to the base;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid on the test sensor;

measuring a first current from the first working electrode from the reduced form of the mediator;

measuring a second current from the second working electrode from the reduced form of the mediator; and

determining the concentration of glucose and correcting for the oxygen effect by using the first current measurement and the second current measurement.

11. The method of claim 10, wherein the fluid is blood.

12. The method of claim 10, wherein the mediator is a ferricyanide derivative.

13. The method of claim 10, wherein the ferricyanide derivative is potassium ferricyanide.

14. The method of claim 10, wherein the mediator is a ruthenium (III) derivative or a ferricium derivative.

15. The method of claim 10, wherein the mediator is an inorganic mediator.

16. The method of claim 10, wherein the test sensor further includes a lid, the lid and the base being attached via an adhesive or heat-sealing.

17. The method of claim 10, wherein the test sensor further includes a lid and a spacer, the spacer being located between the base and the lid.

18. A method for correcting the oxygen effect in determining the concentration of cholesterol in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, and a counter electrode, the first working electrode including cholesterol oxidase, an oxidized form of mediator and peroxidase, the second working electrode including cholesterol oxidase and the oxidized form of the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid on the test sensor;

measuring a first current from the first working electrode from the reduced form of the mediator;

measuring a second current from the second working electrode from the reduced form of the mediator; and

determining the concentration of cholesterol and correcting of the oxygen effect using the first current measurement and the second current measurement.

19. The method of claim 18, wherein the second working electrode including cholesterol oxidase and the mediator in the absence of the peroxidase.

20. A method for correcting the oxygen effect in determining the concentration of at least one of lactate, pyruvate or xanthine in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, and a counter electrode, the first working electrode including lactate, pyruvate or xanthine oxidase, an oxidized form of mediator and peroxidase, the second working electrode including lactate, pyruvate or xanthine oxidase and the oxidized form of the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid on the test sensor;

measuring a first current from the first working electrode from the reduced form of the mediator;

measuring a second current from the second working electrode from the reduced form of the mediator; and

determining the concentration of lactate, pyruvate or xanthine and correcting of the oxygen effect using the first current measurement and the second current measurement.

21. A method for correcting the oxygen effect in determining the concentration of glucose in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, a counter electrode and a lid, the first working electrode including glucose oxidase, a mediator and peroxidase, the second working electrode including glucose oxidase and the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base, the base and the lid assisting in forming one generally flat channel with a test sensor opening;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid into the channel via the test sensor opening;

contacting the fluid with the first working electrode and the second working electrode in the generally flat channel;

measuring a first current from the first working electrode;

measuring a second current from the second working electrode; and

determining the concentration of glucose and correcting for the oxygen effect by using the first current measurement and the second current measurement.

22. The method of claim 21, wherein the mediator is a ferricyanide derivative.

23. The method of claim 21, wherein the test sensor further includes a spacer, the spacer being located between the base and the lid.

24. A method for correcting the oxygen effect in determining the concentration of glucose in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, a counter electrode and a lid, the first working electrode including glucose oxidase, a mediator and peroxidase, the second working electrode including glucose oxidase and the mediator in the absence of the peroxidase, the first working electrode, the second working electrode and the counter electrode being adjacent to the base, the base and the lid assisting in forming one generally flat channel with a test sensor opening;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid into the channel via the test sensor opening;

contacting the fluid with the first working electrode and the second working electrode in the generally flat channel;

measuring a first current from the first working electrode;

measuring a second current from the second working electrode; and

determining the concentration of glucose and correcting for the oxygen effect by using the first current measurement and the second current measurement.

25. The method of claim 24, wherein the test sensor further includes a spacer, the spacer being located between the base and the lid.

26. A method for correcting the oxygen effect in determining the concentration of cholesterol in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, a counter electrode and a lid, the first working electrode including cholesterol oxidase, a mediator and peroxidase, the second working electrode including cholesterol oxidase and the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base, the base and the lid assisting in forming one generally flat channel with a test sensor opening;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid into the channel via the test sensor opening;

contacting the fluid with the first working electrode and the second working electrode in the generally flat channel;

measuring a first current from the first working electrode;

measuring a second current from the second working electrode; and

determining the concentration of cholesterol and correcting of the oxygen effect using the first current measurement and the second current measurement.

27. The method of claim 26, wherein the second working electrode including cholesterol oxidase and the mediator in the absence of the peroxidase.

28. A method for correcting the oxygen effect in determining the concentration of at least one of lactate, pyruvate or xanthine in a fluid using an electrochemical test sensor, the method comprising the acts of:

providing a test sensor, the test sensor comprising a base, first and second working electrodes, a counter electrode and a lid, the first working electrode including lactate, pyruvate or xanthine oxidase, a mediator and peroxidase, the second working electrode including lactate, pyruvate or xanthine oxidase and the mediator, the first working electrode, the second working electrode and the counter electrode being adjacent to the base, the base and the lid assisting in forming one generally flat channel with a test sensor opening;

contacting the test sensor to a meter to form an electrical connection;

placing the fluid into the channel via the test sensor opening;

contacting the fluid with the first working electrode and the second working electrode in the generally flat channel;

measuring a first current from the first working electrode;

measuring a second current from the second working electrode; and

determining the concentration of lactate, pyruvate or xanthine and correcting of the oxygen effect using the first current measurement and the second current measurement.