Biosensor for determining an analyte concentration

• US 10,067,082 B2
• Filed: 06/29/2016
• Issued: 09/04/2018
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Beer, Greg P., Wu, Huan-Ping, Yip, Kin-Fai
• Primary Examiner(s): Slawski, Magali P
• Assistant Examiner(s): Carlson, Kourtney R S
• Application Number:
  US15/197,187
• Publication Number:
  US 20160313272A1
• Time in Patent Office: 797 Days
• Field of Search: 20440301-40315, 2057775
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

A biosensor (102) for determining the presence or amount of a substance in a sample and methods of use of the biosensor (102) are provided. The biosensor (102) for receiving a user sample to be analyzed includes a mixture for electrochemical reaction with an analyte. The mixture includes an enzyme, a mediator and an oxidizable species as an internal reference.

Claims

1. A biosensor for determination of an analyte concentration in a fluid sample, the biosensor comprising:

a working electrode;

a counter electrode; and

a mixture for electrochemical reaction with an analyte, the mixture including the enzyme, a mediator, and an oxidizable species as an internal reference, the mediator being ferricyanide, the oxidizable species being ferrocyanide, the ferrocyanide being from 0.1 to 1% of the total ferricyanide, the mixture being located as a single layer directly on a surface of at least a portion of the working electrode prior to the introduction of the fluid sample, the mixture including only one enzyme.

2. The biosensor of claim 1, wherein the enzyme comprises glucose oxidase.

3. The biosensor of claim 1, wherein the mixture is located as a single layer directly on a surface of at least a portion of the counter electrode prior to the introduction of the fluid sample.

4. A method of forming and applying a reagent mixture for an electrochemical reaction with an analyte of a fluid sample in a biosensor, the biosensor having a working electrode and a counter electrode, the method the acts of comprising:

forming a batch of the reagent mixture by adding an enzyme, adding a mediator and adding a known amount of an oxidizable species, the added oxidizable species being added separately from the mediator, the mediator being ferricyanide, the oxidizable species being ferrocyanide; and

after forming the reagent mixture, placing the reagent mixture directly on a surface of at least a portion of the working electrode of the biosensor prior to the introduction of the fluid sample, the mixture including only one enzyme.

5. The method of claim 4, wherein the enzyme comprises glucose oxidase.

6. The method of claim 4, wherein the mixture is located as a single layer directly on a surface of at least a portion of the counter electrode prior to the introduction of the fluid sample.

7. A method of using a biosensor to assist in determining glucose concentration of a fluid sample, the method comprising:

providing a biosensor including a working electrode, a counter electrode and a reagent, the reagent located directly on a surface of at least a portion of the working electrode prior to introduction of the test sample, the reagent including an enzyme, a mediator and an oxidizable species as an internal reference, the mediator being ferricyanide, the oxidizable species being ferrocyanide, the ferrocyanide being from 0.1 to 1% of the total ferricyanide;

applying a first voltage potential in a first voltage period;

providing a set delay period; and

applying a second voltage potential in a second voltage period following the delay period.

8. The method of claim 7, wherein the enzyme comprises glucose oxidase.

9. The method of claim 7, wherein the mixture is located as a single layer directly on a surface of at least a portion of the counter electrode prior to the introduction of the fluid sample.