Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes

• US 8,632,664 B2
• Filed: 10/27/2009
• Issued: 01/21/2014
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Macfie, Gavin, Webster, Graeme, Cardosi, Marco F., Leach, Christopher Philip, Setford, Steven, Saini, Selwayan
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US12/606,496
• Publication Number:
  US 20110094882A1
• Time in Patent Office: 1,547 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, 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 test meter for use with a dual-chamber, multi-analyte test strip includes a test strip receiving module and a signal processing module. The test strip receiving module has a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the test strip; a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the test strip, a third electrical connector configured for contacting a first counter/reference contact pad of a first counter/reference electrode layer of the test strip, and a fourth electrical connector configured for contacting a second counter/reference contact pad of a second counter/reference electrode layer of the test strip. The signal processing module is configured to receive a first signal via the first electrical connector and the third electrical connector and employ the first signal for the determination of a first analyte (such as glucose) in a bodily fluid sample (for example, whole blood sample) applied to the dual-chamber, multi-analyte test strip. Moreover, the signal processing module is also configured to receive a second signal via the second electrical connector and fourth electrical connector and employ the second signal for the determination of a second analyte (e.g., a ketone analyte) in the bodily fluid sample applied to the dual-chamber, multi-analyte test strip. Furthermore, the third and fourth electrical contacts provide contact in an opposing manner.

Claims

1. A test meter for use with a dual-chamber, multi-analyte test strip, the test meter comprising:

a test strip receiving module with;

a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the dual-chamber, multi-analyte test strip;

a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the dual-chamber, multi-analyte test strip

a third electrical connector configured for establishing an operational electrical contact to a first counter/reference contact pad of a first counter/reference electrode layer of the dual-chamber, multi-analyte test strip; and

a fourth electrical connector configured for establishing an operational electrical contact to a second counter/reference contact pad of a second counter/reference electrode layer of the dual-chamber, multi-analyte test strip; and

a signal processing module,

wherein the signal processing module is configured to receive a first signal via the first electrical connector and the third electrical connector and employ the first signal for the determination of a first analyte in a bodily fluid sample applied to the dual-chamber, multi-analyte test strip; and

wherein the signal processing module is also configured to receive a second signal via the second electrical connector and fourth electrical connector and employ the second signal for the determination of a second analyte in the bodily fluid sample applied to the dual-chamber, multi-analyte test strip, and

wherein the third electrical connector is configured to contact the first counter/reference contact pad in an opposing manner with respect to the contact of the fourth electrical connector and the second counter/reference contact pad; and

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

wherein the test strip receiving module is configured for operationally receiving a multi-analyte test strip with;

a first insulating layer;

a first electrically conductive layer disposed on the first insulating layer, the electrically conductive layer including the first working electrode with the 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 the 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 the 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 the second working electrode with the 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 test meter of claim 1 wherein first electrical connector is configured to contact the first analyte contact pad in an opposing manner with respect to the contact of the second electrical connector with the second analyte contact pad.

3. The test meter of claim 1 wherein the first analyte is non-identical in comparison to the second analyte.

4. The test meter of claim 3 wherein the first analyte is glucose.

5. The test meter of claim 4 wherein the second analyte is a ketone.

6. The test meter of claim 5 wherein the ketone is 3-hydroxybutyrate.

7. The test meter of claim 1 wherein the bodily fluid sample is a whole blood sample.

8. The test meter of claim 1 wherein the signal processing module is configured for determination of the first analyte and determination of the second analyte via an electrochemical-based determination technique.

9. The test meter of claim 1 wherein the signal processing module is configured to receive the first signal and the second signal in a sequential manner.

10. The test meter of claim 1 wherein the signal processing module is configured to receive the first signal and the second signal in a simultaneous manner.