Dry chemistry glucose sensor

• US 5,779,867 A
• Filed: 05/31/1996
• Issued: 07/14/1998
• Est. Priority Date: 10/07/1994
• Status: Expired due to Fees

• Current Assignee: Biomedix, Inc.
• Original Assignee: Biomedix, Inc.
• Inventors: Shieh, Paul
• Primary Examiner(s): TUNG, TA HSUNG
• Application Number:
  US08/657,763
• Time in Patent Office: 774 Days
• Field of Search: 204/418, 204/403, 205/777.5, 435/817, 436/807
• US Class Current: 204/403.12
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

A self contained glucose sensor is provided that generally comprises a strip type glucose sensing electrode having an active surface comprising an organic conducting redox salt dispersed in a polymeric membrane, with the membrane coating a conductive strip and a strip type Ag/AgCl reference electrode having its active surface separated from physical contact with the strip type glucose sensor and a carrier strip of water absorbent paper or film containing an enzyme system and an oxidizable dye. The water absorbent carrier strip is in simultaneous contact with both the active surface of the strip type glucose electrode and the active surface of the strip type reference electrode. When an aqueous solution containing glucose is brought in contact with the carrier strip containing the enzyme system an electrical potential, proportional to the concentration of glucose in the solution, is created which can be detected by an electrometer or other suitable device.

Claims

1. A self contained sensor for the potentiometric assay of glucose comprising:

a sensing electrode strip, the sensing electrode strip comprising;

an electrically insulating base strip and an electrically conductive layer in contact with the base strip and a redox membrane which coats the electrically conductive layer, the redox membrane comprising;

a polymer matrix, the polymer matrix containing;

a plasticizer, and

a complex of 7,7,8,8-tetracyanoquinodimethane and tetrathiafulvalene characterized by a burgundy red coloration, and a reference electrode strip, the reference electrode strip comprising;

an electrically insulating base strip coated with an electrically conductive formulation containing silver and silver chloride, with the reference electrode and the sensing electrode having a gap between them, and a water absorbent carrier strip, the water absorbent carrier strip impregnated with a mixture comprising;

glucose oxidase,

peroxidase,

an oxidizable dye,

at least one surfactant and

at least one thickening agent, with the carrier strip bridging the gap between the sensing electrode strip and the reference electrode strip and in simultaneous contact with the redox membrane of the sensing electrode and the coating of electrically conductive formulation containing silver and silver chloride of the reference electrode.

2. The self contained sensor for the assay of glucose of claim 1 in which the electrically conductive layer of the sensing electrode comprises a conductive graphite formulation and the redox membrane comprises a matrix of polyvinylchloride.

3. The self contained sensor for the assay of glucose of claim 2 in which the water absorbent carrier strip comprises a porous matrix.

4. The self contained sensor for the assay of glucose of claim 3 in which the porous matrix has an effective pore size sufficiently small to filter out formed bodies present in human or animal blood.

5. The self contained sensor for the assay of glucose of claim 3 in which the porous matrix has an effective pore size of about 10 micrometers or less.

6. The self contained sensor for the assay of glucose of claim 3 in which the oxidizable dye is 3,3'"'"',5,5'"'"'-tetramethylbenzidine dihydrochloride.

7. The self contained sensor for the assay of glucose of claim 6 in which the at least one surfactant is chosen from the group consisting of cholic acid, Triton X-100, polyethylene glycol, sodium lauryl sarcosinate and sodium lauryl sulfate or mixtures thereof.

8. The self contained sensor for the assay of glucose of claim 7 in which the at least one thickening agent is chosen from the group consisting of gelatin, methocel or mixtures thereof.

9. The self contained sensor for the assay of glucose of claim 1 in which the sensing electrode strip and the reference electrode strip share a common electrically insulating base strip.

10. The self contained sensor for the assay of glucose of claim 1 in which the reference electrode strip has an opening and the carrier strip is sandwiched between and in simultaneous contact with the redox membrane of the sensing electrode strip and the coating of electrically conductive formulation containing silver and silver chloride of the reference electrode strip and the carrier strip is exposed through the opening in the reference electrode to enable a test sample to be introduced.

11. A potentiometric sensing electrode comprising;

an electrically insulating base strip and an electrically conductive layer in contact with the base strip and a redox membrane which coats the electrically conductive layer, the redox membrane comprising;

a polymer matrix, the polymer matrix containing;

a plasticizer, and

a complex of 7,7,8,8-tetracyanoquinodimethane and tetrathiafulvalene characterized by a burgundy red coloration.

12. The sensing electrode of claim 11 in which the electrically conductive layer comprises a conductive graphite formulation.

13. The sensing electrode of claim 11 in which the redox membrane comprises a matrix of polyvinylchloride.