CA2388272A1 - Electrochemical test strip for use in analyte determination - Google Patents

Electrochemical test strip for use in analyte determination Download PDF

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Publication number
CA2388272A1
CA2388272A1 CA002388272A CA2388272A CA2388272A1 CA 2388272 A1 CA2388272 A1 CA 2388272A1 CA 002388272 A CA002388272 A CA 002388272A CA 2388272 A CA2388272 A CA 2388272A CA 2388272 A1 CA2388272 A1 CA 2388272A1
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CA
Canada
Prior art keywords
test strip
electrochemical test
reaction zone
reagent system
electrodes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002388272A
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French (fr)
Other versions
CA2388272C (en
Inventor
Yeung Siu Yu
Mahesh Shah
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LifeScan Inc
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2388272A1 publication Critical patent/CA2388272A1/en
Application granted granted Critical
Publication of CA2388272C publication Critical patent/CA2388272C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y30/00—Nanotechnology for materials or surface science, e.g. nanocomposites
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y15/00—Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54373—Apparatus specially adapted for solid-phase testing involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
    • G01N33/5438—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 space r 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 gro up 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 (25)

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.
2. The electrochemical test strip according to Claim 1, wherein at least one of said electrodes comprises a metal selected from the group consisting o~ gold, palladium, silver, iridium, carbon, doped indium tin oxide and stainless steel.
3. The electrochemical test strip according to Claim 2, wherein said electrode comprises gold or palladium.
4. The electrochemical test strip according to Claim 1, wherein said self assembling molecules have the formula:

HS-(CH2)n-SO3Y
wherein:
n is an integer from 1 to 6; and Y is H or a cation.
5. The electrochemical test strip according to Claim 1, wherein said at least one enzyme includes an oxidizing enzyme.
6. An electrochemical test strip comprising:

(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-SO3Y
wherein:
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.
7. The electrochemical test strip according to Claim 6, wherein said reaction zone has a volume ranging from about 0.1 to 10 µl.
8. The elctrochemical test strip according to Claim 6, wherein said metal is selected from the group consisting of gold and palladium.
9. The electrochemical test strip according to Claim 6, wherein said enzymes include an oxidizing enzyme.
10. The electrochemical test strip according to Claim 9, wherein said oxidizing enzyme in a glucose oxidizing enzyme.
11. The electrochemical test strip according to Claim 6, wherein said self assembling molecule is 2-mercaptoethane sulfonic acid or a salt thereof.
12. An electrochemical test strip for use in detecting the concentration of glucose in a physiological sample, said test strip comprising:

(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.
13. The electrochemical test strip according to Claim 12, wherein said reaction zone has a volume ranging from about 0.1 to 10 µl.
14. The electrochemical test strip according to Claim 12, wherein said reference electrode is a gold electrode.
15. The electrochemical test strip according to Claim 12, wherein said working electrode is a palladium electrode.
16. A method of determining the concentration of an analyte in a physiological sample, said method comprising:

(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.
17 17. The method according to Claim 16, wherein said self assembling molecules have the formula:
HS-(CH2)n-SO3Y
wherein:
n is an integer from 1 to 6; and Y is H or a cation.
18. The method according to Claim 17, wherein said self assembling molecules are 2-mercaptoethane sulfonic acid or a salt thereof.
19. The method according to Claim 16, wherein said analyte is glucose.
20. The method according to Claim 19, wherein said redox reagent system comprises a glucose oxidizing enzyme.
21. 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 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.
22. The kit according to Claim 21, wherein said analyte is glucose.
23. The kit according to Claim i 21, wherein said physiological sample is blood.
24. The kit according to Claim 21, wherein said means for obtaining said physiological sample is a lance.
25. The kit according to Claim 21, 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.
CA2388272A 2000-02-02 2001-01-25 Electrochemical test strip for use in analyte determination Expired - Lifetime CA2388272C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/497,269 2000-02-02
US09/497,269 US6716577B1 (en) 2000-02-02 2000-02-02 Electrochemical test strip for use in analyte determination
PCT/US2001/002510 WO2001057238A2 (en) 2000-02-02 2001-01-25 Electrochemical test strip for use in analyte determination

Publications (2)

Publication Number Publication Date
CA2388272A1 true CA2388272A1 (en) 2001-08-09
CA2388272C CA2388272C (en) 2011-05-10

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2388272A Expired - Lifetime CA2388272C (en) 2000-02-02 2001-01-25 Electrochemical test strip for use in analyte determination

Country Status (20)

Country Link
US (2) US6716577B1 (en)
EP (1) EP1254365B1 (en)
JP (1) JP4070999B2 (en)
KR (1) KR100856342B1 (en)
CN (1) CN1394278A (en)
AR (1) AR027347A1 (en)
AT (1) ATE449961T1 (en)
AU (2) AU778966C (en)
CA (1) CA2388272C (en)
CZ (1) CZ20022946A3 (en)
DE (1) DE60140600D1 (en)
ES (1) ES2334883T3 (en)
HK (1) HK1050047B (en)
IL (1) IL149661A0 (en)
MX (1) MXPA02005796A (en)
MY (1) MY133963A (en)
PL (1) PL358134A1 (en)
RU (1) RU2256171C2 (en)
TW (1) TW593680B (en)
WO (1) WO2001057238A2 (en)

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