Electrochemical test sensor with reduced sample volume

• US 8,617,367 B2
• Filed: 05/03/2007
• Issued: 12/31/2013
• Est. Priority Date: 05/08/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Edelbrock, Andrew J., Charlton, Steven C.
• Primary Examiner(s): DINH, BACH T
• Application Number:
  US12/226,796
• Publication Number:
  US 20090071847A1
• Time in Patent Office: 2,434 Days
• Field of Search: 20440301-40315, 205/777.5, 205/792
• US Class Current: 204/403.01
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• 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

Abstract

An electrochemical test sensor for detecting the analyte concentration of a fluid test sample includes a base, a dielectric layer, a reagent layer and a lid. The base provides a flow path for the test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current. The dielectric layer forms a dielectric window therethrough. The reagent layer includes an enzyme that is adapted to react with the analyte. The lid is adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the test sample thereto. At least a portion of the width of the counter electrode is greater than the width of the working electrode.

Claims

1. An electrochemical test sensor for detecting the concentration of an analyte in a fluid test sample, the electrochemical test sensor comprising:

a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current;

a dielectric layer forming a dielectric window therethrough;

a reagent layer including an enzyme that is adapted to react with the analyte; and

a lid adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the fluid test sample thereto,

wherein the dielectric layer and the reagent layer are located between the base and the lid,

wherein an exposed portion of the working electrode for being exposed to the fluid test sample is defined in a width-wise dimension by the dielectric window,

wherein an exposed portion of the counter electrode for being exposed to the test fluid sample is defined in a width-wise dimension by at least a portion of the dielectric window and at least a portion of the capillary space, the at least a portion of the dielectric window being different from the at least a portion of the capillary space,

wherein a width of the exposed portion of the counter electrode defined by the dielectric window is different than a width of the exposed portion of the counter electrode defined by the capillary space.

2. The electrochemical test sensor of claim 1, wherein the exposed portion of the counter electrode extends across the full width of the capillary space.

3. The electrochemical test sensor of claim 1, wherein the reagent layer includes glucose dehydrogenase.

4. The electrochemical test sensor of claim 1, wherein the exposed portion of the counter electrode is generally T-shaped.

5. The electrochemical test sensor of claim 1, wherein the volume of the capillary space is less than about 1 μ

L.

6. The electrochemical test sensor of claim 1, further including a spacer, the spacer being located between the lid and the reagent layer.

7. The electrochemical test sensor of claim 1, wherein the lid forms a concave space over the base to assist in forming the capillary space.

8. The electrochemical test sensor of claim 1, wherein the dielectric window includes at least a first section and a second section, the first section having a first width that is different than a second width of the second section.

9. The electrochemical test sensor of claim 8, wherein the dielectric window further includes a third section having a third width that is different than the first width of the first section and the second width of the second section.

10. The electrochemical test sensor of claim 8, wherein the exposed portion of the working electrode is defined in the width-wise dimension by the second width.

11. The electrochemical test sensor of claim 10, wherein the second section of the dielectric window is located on at least a portion of the counter electrode.

12. The electrochemical test sensor of claim 1, wherein the exposed portion of the counter electrode is defined at least in part by an end of the capillary space opposite of the opening.

13. The electrochemical test sensor of claim 1, wherein at least a portion of the width of the exposed portion of the counter electrode is greater than the width of the exposed portion of the working electrode.

14. A method for determining the concentration of an analyte in a fluid test sample with a test sensor, the method comprising the acts of:

providing an electrochemical test sensor including a base, a dielectric layer, a reagent layer and a lid, the base providing a flow path for the fluid test sample having on its surface a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current, the dielectric layer forming a dielectric window therethrough, the reagent layer including an enzyme that is adapted to react with the analyte, the lid being adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the fluid test sample thereto, the dielectric layer and the reagent layer being located between the base and the lid, an exposed portion of the working electrode for being exposed to the fluid test sample being defined in a width-wise dimension by the dielectric window, an exposed portion of the counter electrode for being exposed to the fluid test sample being defined in a width-wise dimension by at least a portion of the dielectric window and at least a portion of the capillary space, the at least a portion of the dielectric window being different from the at least a portion of the capillary space, and a width of the exposed portion of the counter electrode defined by the dielectric window being different than a width of the exposed portion of the counter electrode defined by the capillary space;

contacting the reagent layer with the fluid sample via the capillary space;

generating an electrical signal in the test sensor in response to the presence of the analyte; and

determining a level of the analyte from the electrical signal.