CA2529300A1 - Devices and methods relating to electrochemical biosensors - Google Patents

Devices and methods relating to electrochemical biosensors Download PDF

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Publication number
CA2529300A1
CA2529300A1 CA002529300A CA2529300A CA2529300A1 CA 2529300 A1 CA2529300 A1 CA 2529300A1 CA 002529300 A CA002529300 A CA 002529300A CA 2529300 A CA2529300 A CA 2529300A CA 2529300 A1 CA2529300 A1 CA 2529300A1
Authority
CA
Canada
Prior art keywords
electrodes
test strip
electrode
sample
passageway
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
CA002529300A
Other languages
French (fr)
Other versions
CA2529300C (en
Inventor
Nigel Anthony Surridge
Paul Douglas Walling
Vladimir Svetnik
Melani Sullivan
Brian S. Hill
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F.Hoffmann-La Roche Ag
Nigel Anthony Surridge
Paul Douglas Walling
Vladimir Svetnik
Melani Sullivan
Brian S. Hill
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by F.Hoffmann-La Roche Ag, Nigel Anthony Surridge, Paul Douglas Walling, Vladimir Svetnik, Melani Sullivan, Brian S. Hill filed Critical F.Hoffmann-La Roche Ag
Publication of CA2529300A1 publication Critical patent/CA2529300A1/en
Application granted granted Critical
Publication of CA2529300C publication Critical patent/CA2529300C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • 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
    • 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
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material

Abstract

A system for testing for analytes in a sample of biological fluid includes a test strip that defines a cavity for receiving the sample. At least two sets of electrodes are adjacent the sample cavity, including one for measuring one property of the sample, and another for measuring one or more other properties of the sample, such as temperature and/or the presence or magnitude of confounding variables. The measurements are combined to yield the desired result. At least one set of working and counter electrodes each have a plurality of elongated "fingers" interdigitated with those of the other electrode in the set. The gaps between fingers can be quite small, so that the two electrode sets together can operate in a small measurement volume of sample. Additional electrodes can be included that measure the presence or sufficiency of the sample, and additional traces on the strip can act as configuration identifiers.

Claims (20)

1. In a test strip that defines a capillary passageway, the passageway being dimensioned so as to induce movement of a sample of bodily fluid by capillary action along a predetermined path through the passageway, the improvement comprising:
a first set of electrodes in electrical communication with the passageway for obtaining a first measurement correlated with the concentration of an analyte in the sample; and a second set of electrodes in electrical communication with the passageway for obtaining-a second measurement correlated with a property of the sample which affects the first measurement;
one of the set of electrodes comprising a pair of electrodes with substantially parallel, interdigitated fingers, each electrode having at least two fingers, and each of the fingers being a first distance less than about 50 µm from the nearest other finger in the one set of electrodes, and the other set of electrodes comprising a pair of macro electrodes having one finger each spaced apart a second distance at least 50 µm.
2. The test strip of claim 1 in which the first set of electrodes comprises the pair of electrodes with substantially parallel, interdigitated fingers.
3. The test strip of claim 1 in which the second set of electrodes comprises the pair of electrodes with substantially parallel, interdigitated fingers.
4. The test strip of any one of the preceding claims, wherein each of the interdigitated fingers is at most about 50 µm wide.
5. The test strip of any one of the preceding claims, wherein each of the fingers of the macro electrodes is at least about 50 µm wide.
6. The test strip of any one of the preceding claims, wherein the first distance is a distance of at most about 30 µm.
7. The test strip of any one of the preceding claims, wherein the second distance is a distance of at least 100 microns.
8. The test strip of any one of the preceding claims, and further comprising a third electrode set in electrical communication with the path for determining when a sample has entered a predetermined distance in the passage.
9. The test strip of claim 8, wherein the third electrode set includes at least one dose-detect electrode that is closer to the entrance of the passageway than both the first set of electrodes and the second set of electrodes.
10. The test strip of claim 9, wherein the third electrode set comprises a first dose-detect electrode and a second dose-detect electrode, both of which are closer to the entrance of the passage than both the first set of electrodes and the second set of electrodes.
11. The test strip of claim 8, wherein the third electrode set comprises a pair of sample sufficiency electrodes, both of which are farther from the entrance of the passage than both the first set of electrodes and the second set of electrodes.
12. The test strip of claim 11, and further comprising a fourth electrode set including at least one electrode that is closer to the entrance of the passageway than both the first set of electrodes and the second set of electrodes.
13. The test strip of any one of the preceding claims, wherein the first set of electrodes comprises a first electrode and a second electrode, and the second set of electrodes comprises a third electrode and a fourth electrode, the first electrode and the third electrode being electrically connected to each other, and the second electrode and the fourth electrode being in electrical communication with each other.
14. The test strip of any one of the preceding claims, and further comprising reagent material over the first set of electrodes, where the reagent material combines with the bodily fluid to produce a redox reaction.
15. The test strip of any one of the preceding claims, and further comprising reagent material over the second set of electrodes, where the reagent material combines with the bodily fluid to produce a redox reaction.
16. The test strip of any one of the preceding claims in which the passageway has a volume of at most about 240 nL.
17. The test strip of any one of the preceding claims in which the first and second sets of electrodes are positioned within the passageway such that fluid moving by capillary action along the passageway will encounter the first and second sets in a serial fashion.
18. A method of measuring the concentration of an analyte in a sample of bodily fluid, comprising:
providing a test strip in accordance with any one of the preceding claims;

obtaining a first response to an application of a first electrical signal to the first set of electrodes;
obtaining a second response to an application of a second electrical signal to the second set of electrodes; and using the first response and the second response to derive a measurement of the concentration of the analyte in the sample.
19. The method of claim 18, and further comprising, before the obtaining steps, detecting the application of the sample to the test strip.
20. The method of either of claims 18 or 19, and further comprising, before the obtaining steps, detecting the sufficiency of the volume of the sample.
CA2529300A 2003-06-20 2004-06-18 Devices and methods relating to electrochemical biosensors Expired - Fee Related CA2529300C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US48024303P 2003-06-20 2003-06-20
US60/480,243 2003-06-20
PCT/US2004/019576 WO2004113910A1 (en) 2003-06-20 2004-06-18 Devices and methods relating to electrochemical biosensors

Publications (2)

Publication Number Publication Date
CA2529300A1 true CA2529300A1 (en) 2004-12-29
CA2529300C CA2529300C (en) 2011-10-18

Family

ID=33539277

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2529579A Expired - Fee Related CA2529579C (en) 2003-06-20 2004-06-18 Biosensor with multiple electrical functionalities
CA2529300A Expired - Fee Related CA2529300C (en) 2003-06-20 2004-06-18 Devices and methods relating to electrochemical biosensors

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2529579A Expired - Fee Related CA2529579C (en) 2003-06-20 2004-06-18 Biosensor with multiple electrical functionalities

Country Status (13)

Country Link
US (3) US7867369B2 (en)
EP (3) EP1642125B1 (en)
JP (2) JP4624999B2 (en)
KR (2) KR20070100362A (en)
CN (1) CN1839313B (en)
AU (1) AU2004250223B2 (en)
BR (1) BRPI0411695A (en)
CA (2) CA2529579C (en)
ES (1) ES2657627T3 (en)
HK (1) HK1096151A1 (en)
MX (1) MXPA05013747A (en)
PL (1) PL1642124T3 (en)
WO (2) WO2004113910A1 (en)

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