Dual chamber, multi-analyte test strip with opposing electrodes

• US 8,323,467 B2
• Filed: 10/27/2009
• Issued: 12/04/2012
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Webster, Graeme, Cardosi, Marco F., Leach, Christopher Philip, Setford, Steven, Saini, Selwayan, MacFie, Gavin
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US12/606,467
• Publication Number:
  US 20110094896A1
• Time in Patent Office: 1,134 Days
• Field of Search: 20440301-40315, 2042298-2301, 204/267, 205/775.5, 205/778, 205/787, 205/792, 422/68.1, 422/82.01, 435/4, 435/11, 435/14, 435 25- 28, 436149-151, 600345-347
• US Class Current: 204/403.03
• CPC Class Codes: G01N 2035/00118 for multiple tests
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer. The second patterned spacer layer has a second sample-receiving chamber, with first and second end openings, defined therein. The test strip additionally has a second electrically conductive layer, with a second working electrode, disposed above the second patterned spacer layer, a second insulating layer disposed above the second electrically conductive layer, a first analyte reagent layer disposed on the first working electrode within the first sample-receiving chamber; and a second analyte reagent layer disposed on the second working electrode within the second sample-receiving chamber. The second counter/reference electrode layer is exposed to the second sample receiving chamber and is in an opposing relationship to the second working electrode.

Claims

1. A dual chamber, multi-analyte test strip comprising:

a first insulating layer;

a first electrically conductive layer disposed on the first insulating layer, the electrically conductive layer including a first working electrode with a first analyte contact pad;

a first patterned spacer layer positioned above the first electrically conductive layer, the patterned spacer layer defining a first sample-receiving chamber therein that overlies the first working electrode, the first sample-receiving chamber having a first end opening and a second end opening;

a first counter/reference electrode layer overlying and exposed to the first sample receiving chamber, the first counter/reference electrode layer configured in an opposing relationship to the first working electrode and having a first counter/reference contact pad;

a counter/reference insulating layer disposed over the first counter/reference electrode layer,

a second counter/reference electrode layer disposed over the counter/reference insulating layer the second counter/reference electrode layer having a second counter/reference contact pad,

a second patterned spacer layer positioned above the second counter/reference electrode layer, the second patterned spacer layer defining a second sample-receiving chamber therein with a first end opening and a second end opening;

a second electrically conductive layer disposed above the second patterned spacer layer, the second electrically conductive layer including a second working electrode with a second analyte contact pad;

a second insulating layer disposed above the second electrically conductive layer;

a first analyte reagent layer disposed on at least a portion of the first working electrode within the first sample-receiving chamber; and

a second analyte reagent layer disposed on at least a portion of the second working electrode within the second sample-receiving chamber;

wherein the second sample-receiving chamber overlies the second working electrode, and

wherein the second counter/reference electrode layer is exposed to the second sample receiving chamber and configured in an opposing relationship to the second working electrode.

2. The dual chamber, multi-analyte test strip of claim 1 wherein the dual chamber multi-analyte test strip has a longitudinal axis, a left lateral edge and a right lateral edge, and

wherein the first end opening of the first sample-receiving chamber and the first end opening of the second sample-receiving chamber are on the right lateral edge, and

wherein the second end opening of the first sample-receiving chamber and the second end opening of the second sample-receiving chamber are on the left lateral edge.

3. The dual chamber, multi-analyte test strip of claim 1 wherein the first end opening of the first sample-receiving chamber and the first end opening of the second sample-receiving chamber are aligned on the right lateral edge, and

wherein the second end opening of the first sample-receiving chamber and the second end opening of the second sample-receiving chamber are aligned on the left lateral edge.

4. The dual chamber, multi-analyte test strip of claim 1 wherein the dual chamber, multi-analyte test strip has a bottom side and a top side and wherein the first counter/reference contact pad is exposed on the bottom side, and wherein the second counter/reference contact pad is exposed on the top side.

5. The dual chamber, multi-analyte test strip of claim 4,

wherein the first analyte contact pad is exposed on the top side, and

wherein the second analyte contact pad is exposed on the bottom side.

6. The dual chamber, multi-analyte test strip of claim 1 wherein the bodily fluid sample is a whole blood sample.

7. The dual chamber, multi-analyte test strip of claim 1 wherein the first analyte reagent layer is nonidentical in comparison to the second analyte reagent layer.

8. The dual chamber, multi-analyte test strip of claim 1 wherein the first analyte reagent layer is a glucose analyte reagent layer.

9. The dual chamber, multi-analyte test strip of claim 8 wherein the second analyte reagent layer is a ketone analyte reagent layer.

10. The dual chamber, multi-analyte test strip of claim 9 wherein the ketone is 3-hydroxybutyrate.

11. A method for determining multiple analytes in a single bodily fluid sample, the method comprising:

inserting a dual chamber, multi-analyte test strip into a test meter such that;

a first electrical connector of the test meter comes into contact with a first analyte contact pad of a first working electrode of the dual chamber, multi-analyte test strip;

a second electrical connector of the test meter comes into contact with a second analyte contact pad of a second working electrode of the dual chamber, multi-analyte test strip;

a third electrical connector of the test meter comes into contact with a first counter/reference electrode contact pad of the dual chamber, multi-analyte test strip; and

a fourth electrical connector of the test meter comes into contact with a second counter/reference electrode contact pad of the dual chamber, multi-analyte test strip, and

wherein the third electrical connector and the fourth electrical connector are in an opposing configuration;

determining a first analyte and a second analyte in a single bodily fluid sample applied to the dual chamber, multi-analyte test strip using a signal processing module of the test meter, the single bodily fluid sample having entered a first sample-receiving chamber and a second sample-receiving chamber of the dual chamber, multi-analyte test strip following the application of the bodily fluid sample,

wherein, during the determining step, the signal processing module receives a first signal via the first electrical connector and the third electrical connector and employs the first signal for the determination of the first analyte; and

wherein, during the determining step, the signal processing module receives a second signal via the second electrical connector and the fourth electrical connector and employs the second signal for the determination of the second analyte; and

wherein the first counter/reference electrode layer is configured in an opposing relationship to the first working electrode; and

wherein the second counter/reference electrode layer is configured in an opposing relationship to the second working electrode.

12. The method of claim 11 wherein the first analyte is non-identical in comparison to the second analyte.

13. The method of claim 12 wherein the first analyte is glucose.

14. The method of claim 13 wherein the second analyte is a ketone.

15. The method of claim 14 wherein the second analyte is 3-hydroxybutyrate.

16. The method of claim 11 wherein the bodily fluid sample is a whole blood sample.

17. The method of claim 11 wherein the single bodily fluid sample is applied to a lateral edge of the dual chamber, multi-analyte test strip.

18. The method of claim 11 wherein the determining step includes the signal processing unit receiving the first signal and the second signal in a sequential manner.

19. The method of claim 11 wherein the determining step includes the signal processing receiving the first signal and the second signal simultaneously.

20. The method of claim 11 wherein the bodily fluid sample is applied to the dual chamber, multi-analyte test strip prior to the inserting step.