ELECTROCHEMICAL-BASED ANALYTICAL TEST STRIP WITH INTERSECTING SAMPLE-RECEIVING CHAMBERS

• US 20130341208A1
• Filed: 06/21/2012
• Published: 12/26/2013
• Est. Priority Date: 06/21/2012
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: WHYTE, Lynsey, SLOSS, Scott, WHITEHEAD, Neil, MCCOLL, David, SMITH, Antony
• Granted Patent: US 8,877,023 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements

Abstract

An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (for example, hematocrit) includes a first sample-receiving chamber with first and second sample-application openings, and first and second electrodes. The first and second electrodes are disposed in the first sample-receiving chamber between the first and second sample-application openings. The electrochemical-based analytical test strip also includes a second sample-receiving chamber and a plurality of electrodes disposed in the second sample-receiving chamber. In addition, the second sample-receiving chamber intersects the first sample-receiving chamber between the first and second electrodes, thereby defining a chamber intersection.

Claims

1. An electrochemical-based analytical test strip for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip comprising:

a first sample-receiving chamber with;

a first sample-application opening; and

a second sample-application opening;

a first electrode disposed in the first sample-receiving chamber between the first sample-application opening and the second sample-application opening;

a second electrode disposed in the first sample-receiving chamber between the first sample-application opening and the second sample-application opening;

a second sample-receiving chamber that intersects the first sample-receiving chamber between the first electrode and the second electrode, thereby defining a chamber intersection, and

at least a third electrode disposed in the second sample-receiving chamber.

2. The electrochemical-based analytical test strip of claim 1 wherein the chamber intersection is between the first sample-application opening and the second sample-application opening.

3. The electrochemical-based analytical test strip of claim 1 wherein the first capillary sample-receiving chamber and second capillary sample-receiving chamber are disposed in an essentially T-shaped configuration.

4. The electrochemical-based analytical test strip of claim 3 wherein the T-shaped configuration is symmetrical about a vertical centerline of the electrochemical-based analytical test strip.

5. The electrochemical-based analytical test strip of claim 1 wherein the second sample-receiving chamber has a sample entrance, and

wherein the chamber intersection is configured as the sample entrance of the second sample-receiving chamber.

6. The electrochemical-based analytical test strip of claim 1, further comprising:

an electrically insulating substrate layer;

a patterned conductor layer disposed over the electrically-insulating substrate layer, the patterned conductive layer including the first, second and at least third electrodes;

an enzymatic reagent layer disposed over the patterned conductor layer;

a patterned spacer layer;

a hydrophilic layer; and

a top layer,

wherein the electrically insulating substrate layer, patterned spacer layer, the hydrophilic layer and the top layer essentially define the first sample-receiving chamber, the second sample-receiving chamber, the first sample-application opening and the second-sample application opening.

7. The electrochemical-based analytical test strip of claim 1 wherein the first sample-application opening and the second sample-application opening are on opposing lateral sides of the electrochemical-based analytical test strip.

8. The electrochemical-based analytical test strip of claim 1 wherein the first sample-receiving chamber is a reagent-less sample-receiving chamber.

9. The electrochemical-based analytical test strip of claim 1 wherein the first electrode and second electrode are configured for the determination of hematocrit of a bodily fluid sample in the first sample-receiving chamber.

10. The electrochemical-based analytical test strip of claim 1 wherein the at least third electrode includes a first working electrode, a second working electrode and a counter/reference electrode.

11. The electrochemical-based analytical test strip of claim 10 wherein the first working electrode, a second working electrode and a counter/reference electrode are configured for the determination of an analyte of a bodily fluid sample in the second sample-receiving chamber.

12. The electrochemical-based analytical test strip of claim 11 wherein the analyte is glucose and the bodily fluid sample is blood.

13. A method for determining an analyte in a bodily fluid sample, the method comprising:

applying a bodily fluid sample to either of a first sample-application opening and a second sample-application opening of a first sample-receiving chamber of an electrochemical-based analytical test strip such that the applied bodily fluid sample fills the first sample-receiving chamber and a second-sample-receiving chamber of the electrochemical-based analytical test strip,

measuring a first response of the electrochemical-based analytical test strip that is dependent on bodily fluid sample in the second sample-receiving chamber; and

determining the analyte based on the measured electrochemical response.

14. The method of claim 13 further including:

measuring a second response of the analytical test strip that is dependent on bodily fluid sample in the first capillary sample-receiving chamber; and

determining a characteristic of the bodily fluid sample based on the second measured response.

15. The method of claim 13 wherein the bodily fluid sample is whole blood.

16. The method of claim 15 wherein the analyte is glucose.

17. The method of claim 15 wherein the characteristic is hematocrit.

18. The method of claim 13 wherein:

a first electrode is disposed in the first sample-receiving chamber between the first sample-application opening and the second sample-application opening,

a second electrode is disposed in the first sample-receiving chamber between the first sample-application opening and the second sample-application opening;

the second sample-receiving chamber intersects the first sample-receiving chamber between the first electrode and the second electrode, thereby defining a chamber intersection, and

at least a third electrode disposed in the second sample-receiving chamber.

19. The method of claim 18 wherein the chamber intersection is between the first sample-application opening and the second sample-application opening.

20. The method of claim 19 wherein the first capillary sample-receiving chamber and second capillary sample-receiving chamber are disposed in an essentially T-shaped configuration.

21. The method of claim 18 wherein the second sample-receiving chamber has a sample entrance, and

wherein the chamber intersection is configured as the sample entrance of the second sample-receiving chamber.

22. The method of claim 18 wherein the first sample-application opening and the second sample-application opening are on opposing lateral sides of the electrochemical-based analytical test strip.

23. The method of claim 19 wherein the first sample-receiving chamber is a reagent-less sample-receiving chamber.