Test strip

• US 6,540,891 B1
• Filed: 01/11/2001
• Issued: 04/01/2003
• Est. Priority Date: 05/08/1998
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Stewart, Alan Andrew, Scott, Steven
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/674,891
• Time in Patent Office: 810 Days
• Field of Search: 204/403.01, 204/403.06, 204/403.1, 204/403.11, 204/403.14, 204/403.15
• US Class Current: 204/403.14
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

An improved disposable test strip for use in amperometric measurement of analytes in complex liquid media, such as blood, which has three or more electrodes has been developed. This strip is designed so that different electrical potentials can be maintained between a common pseudo reference/counter electrode and each of the other electrodes upon the imposition of a common potential by an amperometric meter. This capability is imparted to the test strip by providing different circuit resistances for each of these other electrodes. The test strip can be utilized to measure a single analyte such as glucose with a background compensation via a “dummy” electrode or it can be used to measure the concentration of multiple analytes.

Claims

1. A disposable test strip suitable for attachment to the signal readout circuitry of a meter which performs an amperometric test to detect a current representative of the concentration of an analyte in a complex liquid medium comprising:

(a) a working electrode which comprises an electrode pad coated with both a substance designed to engage said analyte in an oxidation-reduction reaction and a mediator compound which will transfer electrons between the oxidation-reduction reaction and the electrode pad;

(b) a dummy electrode which comprises an electrode pad which is coated with about the same amount of mediator compound as the working electrode but lacks the substance which engages the analyte in the oxidation-reduction reaction;

(c) a pseudo reference/counter electrode which comprises an electrode pad coated with a material which contains both the oxidized and reduced form of a chemical species which is designed to undergo a reduction or oxidation reaction to balance the opposite reaction at the working and dummy electrodes; and

(d) three conductive tracks, each of which extends from a contact pad adapted to interface with said readout circuitry to one of the electrode pads and which is in electrical contact with both its contact pad and its electrode pad;

wherein the electrical resistance in the circuit path from the contact pad connected to the dummy electrode through the dummy electrode is significantly greater than the electrical resistance in the circuit path from the contact pad connected to the working electrode through the working electrode.

2. The disposable test strip of claim 1 wherein the greater electrical resistance in the dummy electrode circuit is provided by increasing the resistance of the conductive track connecting the dummy electrode to its contact pad.

3. The disposable test strip of claim 1, further comprising an elongate support having a substantially flat, planar surface arranged to be releasably attached to the readout circuitry.

4. The disposable test strip of claim 3 wherein the three conductive tracks are created by coating conductive particles on the elongated support.

5. The disposable test strip of claim 4 wherein the conductive particles comprise carbon.

6. The disposable test strip of claim 4 wherein a greater electrical resistance is imparted to the conductive track connecting the dummy electrode to its contact pad by using a smaller volume of conductive particles in this track as compared to that used in the conductive track connecting the working electrode to its contact pad.

7. The disposable test strip of claim 1 wherein the conductive track connecting the dummy electrode to its contact pad is narrower than the conductive track connecting the working electrode to its contact pad.

8. The disposable test strip of claim 1 wherein the conductive track connecting the dummy electrode to its contact pad is thinner than the conductive track connecting the working electrode to its contact pad.

9. The disposable test strip of claim 1 wherein the conductive track connecting the dummy electrode to its contact pad has a different composition than the conductive track connecting the working electrode to its contact pad.

10. The disposable test strip of claim 9 wherein both the conductive track connected to the dummy electrode and the conductive track connected to the working electrode are comprised of carbon particles but only the latter conductive track is coated with silver.

11. The disposable test strip of claim 1 wherein the conductive track connecting the dummy electrode to its contact pad is longer than the conductive track connecting the working electrode to its contact pad.

12. The disposable test strip of claim 1 wherein the analyte is glucose and the substance engaging the analyte in an oxidation reduction reaction is an enzyme.

13. The disposable test strip of claim 12 wherein the enzyme is glucose oxidase.

14. The disposable test strip of claim 1 wherein the mediator is a ferrocene derivative.

15. The disposable test strip of claim 1 wherein said pseudo reference/counter electrode comprises an electrode pad coated with a mixture of silver and silver chloride.

16. The disposable test strip of claim 1 wherein the electrical resistance in said dummy electrode circuit is at least 1000 ohms greater than in said working electrode circuit path.

17. A disposable test strip suitable for attachment to the signal readout circuitry of a meter which performs an amperometric test to detect currents representative of the concentrations of multiple analytes in a liquid medium comprising:

(a) a first working electrode which comprises an electrode pad coated with both a substance designed to engage one of the multiple analytes in an oxidation-reduction reaction at a first electrical potential difference and a mediator compound which will transfer electrons between its oxidation-reduction reaction and its electrode pad;

(b) a second working electrode which comprises an electrode pad which is coated with both a substance designed to engage another of the multiple analytes in an oxidation-reduction reaction at a second electrical potential difference which is significantly greater than said first electrical potential difference and another mediator compound which will transfer electrons between its oxidation-reduction reaction and its electrode pad;

(c) a pseudo reference/counter electrode which comprises an electrode pad coated with a material which contains both the oxidized and reduced form of a chemical species which is designed to undergo a reduction or oxidation reaction to balance the opposite reactions at the first and second working electrodes; and

(d) three conductive tracks, each of which extends from a contact pad intended to interface with said readout circuitry to one of the electrode pads and which is in electrical contact with both its contact pad and its electrode pad;

wherein the electrical resistance in the circuit path from the contact pad connected to the first working electrode through the first working electrode is significantly greater than the electrical resistance in the circuit path from the contact pad connected to the second working electrode through the second working electrode.

18. The disposable test strip of claim 17 wherein there are only two working electrodes.

19. The disposable test strip of claim 17 wherein the pseudo reference/counter electrode comprises an electrode pad coated with a mixture of silver and silver chloride.

20. The disposable test strip of claim 17 wherein the first working electrode comprises an enzyme system adapted to engage ketones and a suitable mediator and the second working electrode comprises an enzyme suitable to engage glucose and a suitable mediator.

21. The disposable test strip of claim 20 wherein the first working electrode comprises a HBDH/NADH/1, 10 PQ system and the second working electrode comprises a glucose oxidase and a ferrocene based mediator.

22. The disposable test strip of claim 21 wherein the resistance in the first working electrode circuit is such that when a 400 mV potential exists between the second working electrode and the pseudo reference/counter electrode there is a 200 mV potential between the first working electrode and the pseudo reference/counter electrode.