MULTI-ANALYTE TEST STRIP WITH INLINE WORKING ELECTRODES AND SHARED OPPOSING COUNTER/REFERENCE ELECTRODE

• US 20110079522A1
• Filed: 10/02/2009
• Published: 04/07/2011
• Est. Priority Date: 10/02/2009
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: WEBSTER, Graeme, Saini, Selwayan, Cardosi, Marco F.
• Application Number:
  US12/572,534
• Publication Number:
  US 20110079522A1
• Time in Patent Office: Days
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

A co-facial multi-analyte test strip includes a first insulating layer with an electrically conductive layer disposed thereon. The electrically conductive layer includes a first working electrode with a first analyte contact pad and a second working electrode with a second analyte contact pad. In addition, the first and second working electrodes of the electrically conductive layer are disposed on the first insulating layer in a planar inline configuration. The multi-analyte test strip also includes a patterned spacer layer positioned above the electrically conductive layer, with the patterned spacer layer defining a single bodily fluid sample-receiving chamber therein that overlies the first working electrode and the second working electrode. The multi-analyte test strip further includes a shared counter/reference electrode layer overlying and exposed to the bodily-fluid sample receiving chamber and configured in an opposing relationship to the first and second working electrodes; and a second insulating layer disposed above the shared counter/reference electrode layer. Moreover, the co-facial multi-analyte test strip also has a multi-analyte reagent layer disposed on the electrically conductive layer with the multi-analyte reagent layer having a first analyte reagent portion disposed on the first working electrode within the sample-receiving chamber and a second analyte reagent layer disposed the second working electrode within the sample-receiving chamber.

Claims

1. A co-facial multi-analyte test strip comprising:

a first insulating layer;

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

a first working electrode with a first analyte contact pad; and

a second working electrode with a second analyte contact pad;

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

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

a second insulating layer disposed above the shared counter/reference electrode layer;

wherein the co-facial multi-analyte test strip further includes;

a multi-analyte reagent layer disposed on the electrically conductive layer, the multi-analyte reagent layer including;

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

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

wherein the first working electrode and second working electrode are disposed on the first insulating layer in a planar inline configuration.

2. The co-facial multi-analyte test strip of claim 1 further including a vent opening in fluidic communication with the distal end of the single bodily-fluid sample receiving chamber.

3. The co-facial multi-analyte test strip of claim 2 wherein the vent opening extends entirely through the first insulating layer, electrically conductive layer, patterned spacer layer, shared counter/reference electrode layer and second insulating layer.

4. The co-facial multi-analyte test strip of claim 2 wherein the vent opening is further configured as a stop flow junction at the distal end of the single bodily fluid sample-receiving chamber.

5. The co-facial multi-analyte test strip of claim 1 wherein the test strip has a test strip proximal end and a test strip distal end and the proximal end of the single bodily fluid sample-receiving chamber is open to the proximal end of the test strip.

6. The co-facial multi-analyte test strip of claim 1 wherein the first analyte reagent portion is nonidentical in comparison to the second analyte reagent portion.

7. The co-facial multi-analyte test strip of claim 5 wherein the first analyte reagent portion is a glucose analyte reagent.

8. The co-facial multi-analyte test strip of claim 6 wherein the second analyte reagent portion is a ketone analyte reagent.

9. The co-facial multi-analyte test strip of claim 7 wherein the ketone is 3-hydroxybutyrate.

10. The co-facial multi-analyte test strip of claim 1 wherein the bodily fluid sample is a whole blood sample.

11. A test meter for use with a co-facial multi-analyte test strip, the test meter comprising:

a test strip receiving module with at least;

a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the co-facial multi-analyte test strip;

a second electrical connector configured for contacting a counter/reference electrode contact pad of a shared counter/reference electrode of the multi-analyte test strip; and

a third electrical connector configured for contacting a second analyte contact pad of a second working electrode of the 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 second electrical connector and employ the first signal for the determination of a first analyte in a bodily fluid sample applied to the co-facial multi-analyte test strip; and

wherein the signal processing module is also configured to receive a second signal via the second electrical connector and third electrical connector and employ the second signal for the determination of a second analyte in the bodily fluid sample applied to the co-facial multi-analyte test strip; and

wherein the first electrical connector and third electrical connector are configured for essentially coplanar contact with the first analyte contact pad and the second analyte contact pad and the second electrical contact pad is configured to contact the counter/reference electrode contact pad in a manner offset from the essentially coplanar contact.

12. The test meter of claim 11 wherein the second electrical connector is disposed between the first electrical connector and the third electrical connector.

13. The test meter of claim 11 wherein the first analyte is non-identical in comparison to the second analyte.

14. The test meter of claim 13 wherein the first analyte is glucose.

15. The test meter of claim 14 wherein the second analyte is a ketone.

16. The test meter of claim 15 wherein the ketone is 3-hydroxybutyrate.

17. The test meter of claim 11 wherein the bodily fluid sample is a whole blood sample.

18. The test meter of claim 11 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.

19. The test meter of claim 11 wherein the signal processing module is configured to receive the first signal and the second signal in a sequential manner.

20. The test meter of claim 11 wherein the signal processing module is configured to receive the first signal and the second signal in a simultaneous manner.

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

inserting a co-facial 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 multi-analyte test strip;

a second electrical connector of the test meter comes into contact with a counter/reference electrode contact pad of a shared counter/reference electrode of the multi-analyte test strip; and

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

determining a first analyte and a second analyte in a single bodily fluid sample applied to the co-facial multi-analyte test strip using a signal processing module of the test meter,

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

wherein the first working electrode and second working electrode are disposed on a first insulating layer of the co-facial multi-analyte test strip in a planar inline configuration; and

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

22. The method of claim 21 wherein the first analyte is non-identical in comparison to the second analyte.

23. The method of claim 22 wherein the first analyte is glucose.

24. The method of claim 23 wherein the second analyte is a ketone.

25. The method of claim 24 wherein the second analyte is 3-hydroxybutyrate.

26. The method of claim 21 wherein the bodily fluid sample is a whole blood sample.

27. The method of claim 21 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.

28. The method of claim 21 wherein the determining step includes the signal processing unit receiving the first signal and the second signal in a sequential manner.

29. The method of claim 21 wherein the determining step includes the signal processing receiving the first signal and the second signal simultaneously.

30. The method of claim 21 wherein the bodily fluid sample is applied to the co-facial multi-analyte test strip prior to the inserting step.