Electrochemical test strip kit for analyte determination

• US 7,498,132 B2
• Filed: 09/17/2003
• Issued: 03/03/2009
• Est. Priority Date: 02/02/2000
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Shah, Mahesh, Yu, Yeung Siu
• Primary Examiner(s): FORMAN, BETTY J
• Application Number:
  US10/666,788
• Publication Number:
  US 20040058433A1
• Time in Patent Office: 1,994 Days
• Field of Search: None
• US Class Current: 435/6.11
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a reaction zone defined by opposing metal electrodes separated by a thin spacer layer. The metal surface of at least one of the electrodes is modified by a homogenous surface modification layer made up of linear self-assembling molecules having a first sulfhydryl end group and a second sulfonate end group separated by a short chain alkyl linking group, where 2-mercaptoethane sulfonic acid or a salt thereof is preferred in certain embodiments. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of glucose.

Claims

1. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) an electrochemical test strip comprising;

(i) a reaction zone defined by opposing working and reference metallic electrodes separated by a spacer layer, wherein at least one of said first and second metallic electrodes has a surface modified with a homogenous surface modification layer made up of identical self assembling molecules having a first sulfhydryl end group and a second sulfonate end group, wherein said sulfhydryl and sulfonate end groups are separated by a lower alkyl linker group and wherein the homogeneous surface modification layer renders the surface of the at least one of said first and second metallic electrodes stably hydrophilic; and

(ii) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises at least one enzyme and a mediator; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

 

an analyte standard.

2. The kit according to claim 1, wherein said analyte is glucose.

3. The kit according to claim 1, wherein said physiological sample is blood.

4. The kit according to claim 1, wherein said means for obtaining said physiological sample is a lance.

5. The kit according to claim 1, wherein said kit further comprises an automated instrument for detecting an electrical signal using said electrodes and relating said detected signal to the amount of analyte in a sample.

6. A system for use in determining the concentration of an analyte in a physiological sample, said system comprising:

(a) an electrochemical test strip comprising;

(1) a reaction zone defined by opposing working and reference metallic electrodes separated by a spacer layer, wherein at least one of said first and second metallic electrodes has a surface modified with a homogenous surface modification layer made up of identical self assembling molecules having a first sulfhydryl end group and a second sulfonate end group, wherein, said sulfhydryl and sulfonate end groups are separated by a lower alkyl linker group and wherein the homogeneous surface modification layer renders the surface of the at least one of said first and second metallic electrodes stably hydrophilic; and

(2) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises at least one enzyme and a mediator; and

(b) an automated instrument.