End-fill electrochemical-based analytical test strip with perpendicular intersecting sample-receiving chambers

• US 9,453,812 B2
• Filed: 06/24/2014
• Issued: 09/27/2016
• Est. Priority Date: 06/24/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Cooper, Alexander, Lloyd, Timothy, Smith, Antony, Whyte, Lynsey, Whitehead, Neil, McColl, David, Guthrie, Brian, Massari, Rossano, Forlani, Christian
• Primary Examiner(s): White, Dennis M
• Application Number:
  US14/313,377
• Publication Number:
  US 20150369769A1
• Time in Patent Office: 826 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: G01N 2030/645 electrical conductivity detectors
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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 31/164 by electrical or electrochemical means
• CPC Class Codes: G01N 33/0031 comprising two or more sensors, e.g. a sensor array

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 (e.g., hematocrit) includes a sample-entry chamber with a sample-application opening disposed on an end edge of the electrochemical-based analytical test strip, and first and second sample-determination chambers, each in direct fluidic communication with the sample-entry chamber. The electrochemical-based analytical test strip also includes first and second electrodes (such as first and second hematocrit electrodes) disposed in the first sample-determination chamber, and a third and fourth electrodes (for example working and reference electrodes) disposed in the second sample-determination chamber. Moreover, the first and second sample-determination chambers intersect the sample-entry chamber perpendicular (or nearly perpendicular) to one another and the first sample-determination chamber also intersects the sample-entry chamber in an aligned manner.

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 sample-entry chamber with a sample-application opening, the sample-application opening disposed on an end edge of the electrochemical-based analytical test strip;

a first sample-determination chamber in direct fluidic communication with the sample-entry chamber;

a second sample-determination chamber in direct fluidic communication with the sample-entry chamber;

a first electrode and a second electrode disposed in the first sample-determination chamber;

at least a third electrode and a fourth electrode disposed in the second sample-determination chamber, and

wherein the first sample-determination chamber and the second sample-determination chamber intersect the sample-entry chamber nearly perpendicular to one another; and

wherein the first sample-determination chamber intersects the sample-entry chamber in an aligned manner.

2. The electrochemical-based analytical test strip of claim 1 further including:

a reagent layer disposed on the at least third electrode and fourth electrode.

3. The electrochemical-based analytical test strip of claim 1 further including a shield electrode, the shield electrode being disposed in the sample-entry chamber between the sample-application opening and the first sample-determination chamber.

4. The electrochemical-based analytical test strip of claim 3 wherein the shield electrode is configured to reduce an electrical proximity effect of a user'"'"'s body applying a bodily fluid sample to the electrochemical-based analytical test strip.

5. 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 electrode, second electrode and at least third electrode and fourth electrode;

a reagent layer disposed over the at least third electrode and fourth electrode of the patterned conductor layer;

a patterned spacer layer; and

a hydrophilic top layer,

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

6. The electrochemical-based analytical test strip of claim 5 wherein the first sample-determination chamber is a reagent-less sample-determination chamber.

7. 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-determination chamber.

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

9. The electrochemical-based analytical test strip of claim 8 further including shield electrode disposed in the sample-entry chamber between the sample-application opening and the first sample-determination chamber, the shield electrode being in electrical communication with the counter/reference electrode.

10. The electrochemical-based analytical test strip of claim 1 wherein the first and second electrodes are separated by a distance in the range of 0.9 mm to 1.5 mm in the first sample-receiving chamber.

11. The electrochemical-based analytical test strip of claim 10 wherein the analyte is glucose and the bodily fluid sample is blood.

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

applying a bodily fluid sample to a sample application opening of a sample-entry chamber of an electrochemical-based analytical test strip such that the applied bodily fluid sample is transported into a first sample-determination chamber and a second sample-determination chamber of the electrochemical-based analytical test strip, and

determining a characteristic of the applied bodily fluid sample, using a first electrode and a second electrode disposed in the first sample-determination chamber, and an analyte in the bodily fluid sample using at least a third electrode and a fourth electrode disposed in the second sample-determination chamber;

wherein the first sample-determination chamber and the second sample-determination chamber intersect the single sample-entry chamber nearly perpendicular to one another; and

wherein the first sample-determination chamber intersects the sample-entry chamber in an aligned manner, and

wherein the sample-application opening is disposed on an end edge surface of the electrochemical-based analytical test strip.

13. The method of claim 12 wherein the bodily fluid sample is whole blood.

14. The method of claim 13 wherein the analyte is glucose.

15. The method of claim 13 wherein the characteristic is hematocrit.

16. The method of claim 13 wherein the electrochemical-based analytical test strip includes a shield electrode disposed in the sample-entry chamber.

17. The method of claim 16 wherein the shield electrode is configured to reduce an electrical proximity effect of a user'"'"'s body applying a bodily fluid sample to the electrochemical-based analytical test strip.

18. The method of claim 17 wherein the shield electrode is in electrical communication with one of the at least third electrode and fourth electrode.

19. The method of claim 13 wherein the electrochemical-based analytical test strip includes a reagent layer disposed in the second sample-determination chamber.

20. The method of claim 13 wherein the first sample-determination chamber is devoid of reagent.

21. The method of claim 13 wherein the first and second electrodes are separated by a distance in the range of 0.9 mm to 1.5 mm in the first sample-receiving chamber.