Electrochemical test sensor with reduced sample volume

• US 9,304,099 B2
• Filed: 11/01/2013
• Issued: 04/05/2016
• Est. Priority Date: 05/08/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Edelbrock, Andrew J., Charlton, Steven C.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kaur, Gurpreet
• Application Number:
  US14/070,169
• Publication Number:
  US 20140124382A1
• Time in Patent Office: 886 Days
• US Class Current: 1/1
• 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;

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 window comprises a first window section, a second window section and a third window section and a first portion of the capillary space encompasses an area of the first window section and an area of the second window section and a second portion of the capillary space is encompassed by an area of the third window section, the dielectric layer and the reagent layer being located between the base and the lid; and

a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current, wherein an exposed portion of the working electrode for being exposed to the fluid test sample is defined by at least a portion of the area of the second window section, wherein an exposed portion of the counter electrode for being exposed to the fluid test sample is defined by at least the portion of the area of the second window section and further defined by at least the second portion of the capillary space.

2. The electrochemical test sensor of claim 1, further comprising at least one vent, the exposed portion of the counter electrode being further defined by the at least one vent.

3. The electrochemical test sensor of claim 1, wherein the exposed portion of the counter electrode is a non-polygonal shape.

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

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

6. The electrochemical test sensor of claim 5, wherein the lid forms a concave space over the base to assist in forming the capillary space.

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 first window section having a first width that is different than a second width of the second window section.

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

10. The electrochemical test sensor of claim 9, wherein the exposed portion of the working electrode is defined by the second width of the second window section of the dielectric window, and at least a portion of a width of the exposed portion of the counter electrode is greater than a width of the exposed portion of the working electrode.

11. 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;

a dielectric layer located between the base and the lid, the dielectric layer forming a dielectric window therethrough;

a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current;

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 window comprises a first window section, a second window section and a third window section and a first portion of the capillary space encompasses an area of the first window section and an area of the second window section and a second portion of the capillary space is encompassed by an area of the third window section,

wherein the reagent layer is located between the base and the lid, and

wherein an exposed portion of the counter electrode being exposed to the fluid test sample is defined at least in part by an end of the capillary space opposite of the opening, and further defined by at least a portion of the area of the second window section and further defined by the second portion of the capillary space.

12. The electrochemical test sensor of claim 11, further comprising a spacer located between the lid and the reagent layer, the end of the capillary space opposite the opening being defined at least in part by the spacer.

13. The electrochemical test sensor of claim 11, wherein the lid forms a concave space over the base to assist in forming the capillary space, the end of the capillary space opposite the opening being defined at least in part by the concave space.

14. The electrochemical test sensor of claim 11, wherein the lid further forms at least one air vent that also defines the exposed portion of the counter electrode.

15. The electrochemical test sensor of claim 11, wherein the exposed portion of the counter electrode is a non-polygonal shape.

16. The electrochemical test sensor of claim 11, wherein at least a portion of the width of the exposed portion of the counter electrode is greater than the width of a portion of the working electrode exposed to the fluid test sample.

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

providing an electrochemical test sensor including a base that provides a flow path for the fluid test sample, a counter electrode and a working electrode adapted to electrically communicate with a detector of electrical current, a reagent layer including an enzyme that is adapted to react with the analyte, a dielectric layer located between the base and the lid, the dielectric layer forming a dielectric window therethrough, 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 window comprises a first window section, a second window section and a third window section and a first portion of the capillary space encompasses an area of the first window section and an area of the second window section and a second portion of the capillary space is encompassed by an area of the third window section, the reagent layer being located between the base and the lid, an exposed portion of the counter electrode being exposed to the fluid test sample being defined by at least a portion of the area of the second window section and further defined by at least the second portion of 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 concentration of the analyte in the fluid sample from the electrical signal.