Electrochemical test strip for use in analyte determination
First Claim
1. An electrochemical test strip comprising:
- (a) a reaction zone defined by opposing working and reference electrodes separated by a spacer layer, wherein at least one of said first and second electrodes has a surface modified with a homogenous surface modification layer made up of 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
(b) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises at least one enzyme and a mediator.
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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.
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Citations
25 Claims
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1. An electrochemical test strip comprising:
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(a) a reaction zone defined by opposing working and reference electrodes separated by a spacer layer, wherein at least one of said first and second electrodes has a surface modified with a homogenous surface modification layer made up of 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
(b) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises at least one enzyme and a mediator. - View Dependent Claims (2, 3, 4, 5)
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6. An electrochemical test strip comprising:
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(a) a reaction zone defined by opposing working and reference electrodes comprising a metal surface separated by a thin 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 self assembling molecules of the formula;
HS—
(CH2)n—
SO3Ywherein;
n is an integer from 1 to 6; and
Y is H or a cation; and
(b) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises enzymes and a mediator. - View Dependent Claims (7, 8, 9, 10, 11)
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12. An electrochemical test strip for use in detecting the concentration of glucose in a physiological sample, said test strip comprising:
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(a) a reaction zone defined by opposing working and reference electrodes comprising a metal surface selected from the group consisting of gold and palladium separated by a thin 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 2-mercaptoethane sulfonic acid or a salt thereof; and
(b) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises a glucose oxidizing enzyme and a mediator. - View Dependent Claims (13, 14, 15)
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16. A method of determining the concentration of an analyte in a physiological sample, said method comprising:
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(a) applying said physiological sample to 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 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
(ii) a redox reagent system present in said reaction zone, wherein said redox reagent system comprises at least one enzyme and a mediator;
(b) detecting an electrical signal in said reaction zone using said metallic electrodes; and
(c) relating said detected electrical signal to the amount of said analyte in said sample. - View Dependent Claims (17, 18, 19, 20)
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21. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:
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(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 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
(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
(ii) an analyte standard. - View Dependent Claims (22, 23, 24, 25)
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Specification