ANALYTE TEST STRIP WITH ELECTRICALLY DISTINGUISHABLE DIVIDED ELECTRODE

• US 20120048746A1
• Filed: 08/30/2010
• Published: 03/01/2012
• Est. Priority Date: 08/30/2010
• Status: Abandoned Application

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: BLYTHE, Stephen Patrick, Mills, Leanne, Mackintosh, Stephen
• Application Number:
  US12/871,616
• Publication Number:
  US 20120048746A1
• Time in Patent Office: Days
• US Class Current: 205/777.5
• 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 33/5438 Electrodes

Abstract

An analyte test strip for use with a test meter includes a first insulating layer, a first electrically conductive layer disposed on the first insulating layer, a second insulating layer disposed above the first insulating layer, and a patterned spacer layer, positioned between the first insulating layer and the first electrically conductive layer, that defines a sample-receiving chamber. Moreover, the electrically conductive layer includes an electrode portion that is divided into a first electrode sub-portion and a second electrode sub-portion. The electrically conductive layer also includes (i) a first electrical contact pad in electrical communication with the first electrode sub-portion and configured to communicate an electrical response of the first electrical sub-portion to the test meter, and (ii) a second electrical contact pad in electrical communication with the second electrode sub-portion and configured to communicate an electrical response of the second electrical sub-portion to the test meter. In addition, the first electrode sub-portion is electrically isolated from the second electrode sub-portion and the first electrical contact pad is electrically isolated from the second electrical contact pad. Furthermore, the ratio of the area of the first electrode sub-portion and the area of the second electrode sub-portion is predetermined such that the ratio can be electrically distinguished by the test meter based on the first and second electrode sub-portion electrical responses.

Claims

1. An analyte test strip for use with a test meter, the analyte test strip comprising:

a first insulating layer;

a first electrically conductive layer disposed on the first insulating layer, the first electrically conductive layer including;

an electrode portion, the electrode portion divided into a first electrode sub-portion and a second electrode sub-portion;

a first electrical contact pad in electrical communication with the first electrode sub-portion and configured to communicate an electrical response of the first electrical sub-portion to the test meter; and

a second electrical contact pad in electrical communication with the second electrode sub-portion and configured to communicate an electrical response of the second electrical sub-portion to the test meter;

a second insulating layer disposed above the first insulating layer;

a patterned spacer layer positioned between the first insulating layer and the first electrically conductive layer, the patterned spacer layer defining a sample-receiving chamber therein;

wherein the first electrode sub-portion is electrically isolated from the second electrode sub-portion and the first electrical contact pad is electrically isolated from the second electrical contact pad; and

wherein the ratio of the area of the first electrode sub-portion and the area of the second electrode sub-portion is predetermined such that the ratio can be electrically distinguished by the test meter based on the electrical response of the first electrode sub-portion and the electrical response of the second electrode sub-portion.

2. The analyte test strip of claim 1 wherein the ratio of the area of the first electrode sub-portion and the area of the second electrode sub-portion is in the range of 1:

1 to 4;

1.

3. The analyte test strip of claim 2 wherein the ratio of the first electrode sub-portion and the area of the second electrode sub-portion is one of a 1:

1 ratio, a 3;

1 ratio and a 1;

3 ratio.

4. The analyte test strip of claim 1 wherein the ratio of the first electrode sub-portion and the area of the second electrode sub-portion is one of a 1:

8 ratio, a 2.75;

5.25 ratio and a 7;

1 ratio.

5. The analyte test strip of claim 1 wherein the ratio of the first electrode sub-portion and the area of the second electrode sub-portion is one of a 1:

8 ratio, a 2;

6 ratio, a 3.5;

4.5 ratio, a 5;

3 ratio, and a 7;

1 ratio.

6. The analyte test strip of claim 1 further including a scribe line and wherein the scribe line divides the electrode portion into a first electrode sub-portion and a second electrode sub-portion.

7. The analyte test strip of claim 6 wherein the scribe line is configured in a straight line across the electrode portion.

8. The analyte test strip of claim 6 wherein the scribe line has a width in the range of 1 μ

m to 200 μ

m.

9. The analyte test strip of claim 1 wherein the electrode portion is configured as a working electrode.

10. The analyte test strip of claim 1 wherein the first electrically conductive layer is a palladium layer.

11. The analyte test strip of claim 1 further including a second electrically conductive layer disposed on the second insulating layer.

12. The analyte test strip of claim 1 wherein the electrical response of the first electrode sub-portion is a current response and electrical response of the second electrode sub-portion is a current response.

13. The analyte test strip of claim 1 wherein the analyte test strip is an electrochemical-based analyte test strip.

14. The analyte test strip of claim 10 wherein the analyte test strip is configured for the determination of glucose in a whole blood sample.

15. The analyte test strip of claim 1 wherein the first electrode sub-portion and the second electrode sub-portion are in a side-by-side configuration.

16. The analyte test strip of claim 1 wherein the electrical response of the first electrode sub-portion is an electrical current response and the electrical response of the second electrode sub-portion is an electrical current response.

17. A test meter for use with an analyte test strip, the test meter comprising:

a test strip receiving module with a first electrical connector pin and a second electrical connector pin; and

a signal processing module,

wherein the first electrical connector pin is configured;

to contact a first electrical contact pad of an analyte test trip, the first electrical contact pad being in electrical communication with a first electrode sub-portion of the analyte test strip; and

to communicate an electrical response of the first electrical sub-portion to the signal processing module; and

wherein the second electrical connector pin is configured;

to contact a second electrical contact pad of the analyte test trip, the second electrical contact pad being in electrical communication with a second electrode sub-portion of the analyte test strip; and

to communicate an electrical response of the second electrical sub-portion to the signal processing module; and

wherein the signal processing module is configured to electrically distinguish a ratio of the area of the first electrode sub-portion and the area of the second electrode sub-portion based on the electrical response of the first electrode sub-portion and the electrical response of the second electrode sub-portion and, thereby, identify the analyte test strip.

18. The test meter of claim 17 wherein the signal processing module is configured to electrically distinguish the ratio of area as a ratio in the range of 1:

1 to 4;

1.

19. The test meter of claim 17 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

1 ratio, a 3;

1 ratio and a 1;

3 ratio.

20. The test meter of claim 17 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

8 ratio, a 2.75;

5.25 ratio and a 7;

1 ratio.

21. The test meter of claim 17 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

8 ratio, a 2;

6 ratio, a 3.5;

4.5 ratio, a 5;

3 ratio, and a 7;

1 ratio.

22. The test meter of claim 17 wherein the test meter is further configured to determine an analyte in a bodily fluid sample applied to the analyte test strip.

23. The test meter of claim 17 wherein the electrical response of the first electrode sub-portion is a current response and electrical response of the second electrode sub-portion is a current response.

24. The test meter of claim 17 wherein the test meter further includes a display module and wherein the display module and signal processing module are configured to display a message indicating the suitability for use of the analyte test strip based on the identity of the analyte test strip.

25. The test meter of claim 17 wherein the analyte test strip is an electrochemical-based analyte test strip.

26. The test meter of claim 25 wherein the analyte test strip is configured for the determination of glucose in a whole blood sample.

27. A method for the determination of an analyte in a bodily fluid sample, the method comprising:

inserting an analyte test strip into a test meter such that;

a first electrical connector pin of the test meter contacts a first electrical contact pad of an analyte test trip, the first electrical contact pad being in electrical communication with a first electrode sub-portion of the analyte test strip; and

a second electrical connector pin of the test meter contacts a second electrical contact pad of an analyte test trip, the second electrical contact pad being in electrical communication with a second electrode sub-portion of the analyte test strip,

communicating an electrical response of the first electrode sub-portion and an electrical response of the second electrode sub-portion to a signal processing module of the test meter via the first electrical connector pin and the second electrical connector pin respectively;

distinguishing, by employment of the signal processing module, a ratio of the area of the first electrode sub-portion and the area of the second electrode sub-portion based on the electrical response of the first electrode sub-portion and the electrical response of the second electrode sub-portion;

identifying the analyte test strip based on the distinguished ratio;

ascertaining the suitability of the analyte test strip for use with the test meter based on the identity of the analyte test strip; and

determining, dependent on the suitability of the analyte test strip, an analyte in a bodily fluid sample applied to the analyte test strip.

28. The method of claim 27 wherein the first electrode sub-portion and the second electrode sub-portion are sub-portions of a working electrode portion of the analyte test strip.

29. The method of claim 27 wherein the signal processing module is configured to electrically distinguish the ratio of area as a ratio in the range of 1:

1 to 4;

1.

30. The method of claim 27 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

1 ratio, a 3;

1 ratio and a 1;

3 ratio.

31. The method of claim 27 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

8 ratio, a 2.75;

5.25 ratio and a 7;

1 ratio.

32. The method of claim 27 wherein the signal processing module is configured to electrically distinguish the ratio of area as one of a 1:

8 ratio, a 2;

6 ratio, a 3.5;

4.5 ratio, a 5;

3 ratio, and a 7;

1 ratio.

33. The method of claim 27 wherein the electrical response of the first electrode sub-portion is a current response and electrical response of the second electrode sub-portion is a current response

34. The method of claim 27 wherein the analyte is glucose and the bodily fluid sample is a whole blood sample.

35. The method of claim 27 further including the step of:

displaying, on a display module of the test meter, a message indicating the suitability for use of the analyte test strip based on the identity of the analyte test strip.

36. The method of claim 27 wherein the analyte test strip is configured as an electrochemical-based analyte test strip.

37. The method of claim 27 further including the step of:

displaying, on a display module of the test meter, a message indicating both the suitability for use of the analyte test strip based on the identity of the analyte test strip and the results of the determination step.