Electrochemical test strip having a plurality of reaction chambers and methods for using the same

• US 6,855,243 B2
• Filed: 04/27/2001
• Issued: 02/15/2005
• Est. Priority Date: 04/27/2001
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Khan, Tahir S.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/844,929
• Publication Number:
  US 20040217016A1
• Time in Patent Office: 1,390 Days
• Field of Search: 204/403.01, 204/403.03, 204/403.04, 204/403.14, 204/409, 204/411, 204/412, 205/777.5, 205/775, 205/792
• US Class Current: 205/777.5
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a plurality of reaction zones defined by opposing metal electrodes separated by a thin spacer layer. The reagent compositions present in each reaction zone may be the same or different. In addition, each reaction zone may have a separate fluid ingress channel, or two or more of the reaction zones may have fluid ingress channels that merge into a single channel. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of glucose.

Claims

1. An electrochemical test strip comprising:

(a) a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer, wherein each of said reaction zones is defined by a bore through said spacer layer and further wherein each of said reaction zones has its own fluid ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) a reagent composition present in each of said reaction zones.

2. The electrochemical test strip according to claim 1, wherein said test strip comprises from 2 to 25 reaction zones.

3. The electrochemical test strip according to claim 1, wherein each of said reaction zones houses the same reagent composition.

4. The electrochemical test strip according to claim 1, wherein at least two of said reaction zones house different reagent compositions.

5. The electrochemical test strip according to claim 1, wherein at least one of said electrodes comprises a material selected from the group consisting of gold, palladium, silver, iridium, carbon, platinum, nichrome, doped indium tin oxide and stainless steel.

6. The electrochemical test strip according to claim 5, wherein said electrode comprises gold or palladium.

7. The electrochemical test strip according to claim 1, wherein each of said reaction zones has a volume ranging from about 0.1 to 10 μ

l.

8. The electrochemical test strip according to claim 1, wherein said reference electrode is a gold electrode.

9. The electrochemical test strip according to claim 1, wherein said working electrode is a palladium electrode.

10. The electrochemical test strip according to claim 1, wherein said strip is present in a meter.

11. The electrochemical test strip according to claim 1, wherein at least one of said reagent compositions is a redox reagent system.

12. The electrochemical test strip according to claim 11, wherein said redox reagent system comprises at least one enzyme and a mediator.

13. The electrochemical test strip according to claim 12, wherein said at least one enzyme includes an oxidizing enzyme.

14. The electrochemical test strip according to claim 13, wherein said oxidizing enzyme in a glucose oxidizing enzyme.

15. A method of determining the concentration of an analyte in a physiological sample, said method comprising:

(a) applying said physiological sample to an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones, wherein each of said reactions zones are provided by a bore through said spacer layer and further wherein each of said reaction zones has its own fluid ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip;

(b) detecting an electrical signal in said reaction zone using said opposing electrodes; and

(b) relating said detected electrical signal to the amount of said analyte in said sample.

16. The method according to claim 15, wherein said analyte is glucose.

17. The method according to claim 16, wherein said redox reagent system comprises a glucose oxidizing enzyme.

18. The method according to claim 15, wherein said method comprises employing a meter.

19. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones, wherein each of said reaction zones are provided by a bore through said spacer layer and further wherein each of said reaction zones has its own fluid ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

(ii) an analyte standard.

20. The kit according to claim 19, wherein said means for obtaining said physiological sample is a lance.

21. The kit according to claim 19, wherein said kit further comprises a meter.

22. A system for use in determining the concentration of an analyte in a physiological sample, said system comprising:

(a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones, wherein each of said reaction zones are provided by a bore through said spacer layer and further wherein each of said reaction zones has its own fluid ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) a meter.

23. The system according to claim 22, wherein said system further comprises a means for obtaining said physiological sample.

24. The system according to claim 22, wherein said system further comprises an analyte standard.

25. An electrochemical test strip comprising:

a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer, wherein each of said reaction zones is defined by a bore through said spacer layer and further wherein at least two of said reaction zones have fluid ingress channels that merge to produce a single ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) a reagent composition present in each of said reaction zones.

26. The electrochemical test strip according to claim 25, wherein said test strip comprises from 2 to 25 reaction zones.

27. The electrochemical test strip according to claim 25, wherein each of said reaction zones houses the same reagent composition.

28. The electrochemical test strip according to claim 25, wherein at least two of said reaction zones house different reagent composition.

29. The electrochemical test strip according to claim 25, wherein at least one of said reagent compositions is a redox reagent system.

30. The electrochemical test strip according to claim 29, wherein said at least one enzyme includes an oxidizing enzyme.

31. The electrochemical test strip according to claim 30, wherein said oxidizing enzyme is a glucose oxidizing enzyme.

32. A method of determining the concentration of an analyte in a physiological sample, said method comprising:

(a) applying said physiological sample to an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each said reaction zones, wherein each of said reactions zones are provided by a bore through said spacer layer and further wherein at least two of said reaction zones have fluid ingress channels that merge to produce a single ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip;

(b) detecting an electrical signal in said reaction zone using said opposing electrodes;

(c) relating said detected electrical signal to the amount of said analyte in said sample.

33. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones, wherein each of said reaction zones are provided by a bore through said spacer layer and further wherein at least two of said reaction zones have fluid ingress channels that merge to produce a single ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

(ii) an analyte standard.

34. A system for use in determining the concentration of an analyte in a physiological sample, said system comprising:

(a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones, wherein each of said reaction zones are provided by a bore through said spacer layer and further wherein at least two of said reaction zones have fluid ingress channels that merge to produce a single ingress channel to provide for fluid communication between said reaction zones and the external environment of said test strip; and

(b) a meter.