CA2358464A1 - Disposable test strips with integrated reagent/blood separation layer - Google Patents

Disposable test strips with integrated reagent/blood separation layer Download PDF

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Publication number
CA2358464A1
CA2358464A1 CA002358464A CA2358464A CA2358464A1 CA 2358464 A1 CA2358464 A1 CA 2358464A1 CA 002358464 A CA002358464 A CA 002358464A CA 2358464 A CA2358464 A CA 2358464A CA 2358464 A1 CA2358464 A1 CA 2358464A1
Authority
CA
Canada
Prior art keywords
test strip
filler
separation layer
blood separation
glucose
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
CA002358464A
Other languages
French (fr)
Other versions
CA2358464C (en
Inventor
Jerome F. Mcaleer
David Scott
Geoff Hall
Manuel Alvarez-Icaza
Elliott V. Plotkin
Oliver W. H. Davies
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.)
LifeScan Scotland Ltd
Original Assignee
Inverness Medical Technology, Inc.
Jerome F. Mcaleer
David Scott
Geoff Hall
Manuel Alvarez-Icaza
Elliott V. Plotkin
Oliver W. H. Davies
Selfcare, Inc.
Sunrise Acquistion Corp.
Diabetes Diagnostics, Inc.
Lifescan, Inc.
Lifescan Scotland Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22858812&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2358464(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Inverness Medical Technology, Inc., Jerome F. Mcaleer, David Scott, Geoff Hall, Manuel Alvarez-Icaza, Elliott V. Plotkin, Oliver W. H. Davies, Selfcare, Inc., Sunrise Acquistion Corp., Diabetes Diagnostics, Inc., Lifescan, Inc., Lifescan Scotland Limited filed Critical Inverness Medical Technology, Inc.
Publication of CA2358464A1 publication Critical patent/CA2358464A1/en
Application granted granted Critical
Publication of CA2358464C publication Critical patent/CA2358464C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • C12Q1/002—Electrode membranes
    • 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
    • C12Q1/004—Enzyme electrodes mediator-assisted
    • 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
    • C12Q1/005—Enzyme electrodes involving specific analytes or enzymes
    • C12Q1/006—Enzyme electrodes involving specific analytes or enzymes for glucose
    • 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
    • C12Q1/54—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
    • 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
    • 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
    • G01N33/5002—Partitioning blood components

Abstract

An improved disposable glucose test strip for use in a test meter of the typ e which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis using a non-conductive integrated reagent/blood separation layer (17) containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The integrated layer formulation is printed over a conductive carbon element (16) to form a working electrode. T he filler, for example a silica filler, is selected to have a balance of hydrophobicity such that on drying it forms a two-dimensional network on the surface of the conductive element. The response of this test strip is essentially temperature independent over relevant temperature ranges and is substantially insensitive to the hematocrit of the patient.
CA002358464A 1999-01-12 2000-01-11 Disposable test strips with integrated reagent/blood separation layer Expired - Lifetime CA2358464C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/228,855 US6241862B1 (en) 1996-02-14 1999-01-12 Disposable test strips with integrated reagent/blood separation layer
US09/228,855 1999-01-12
PCT/US2000/000620 WO2000042422A1 (en) 1999-01-12 2000-01-11 Disposable test strips with integrated reagent/blood separation layer

Publications (2)

Publication Number Publication Date
CA2358464A1 true CA2358464A1 (en) 2000-07-20
CA2358464C CA2358464C (en) 2008-08-26

Family

ID=22858812

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002358464A Expired - Lifetime CA2358464C (en) 1999-01-12 2000-01-11 Disposable test strips with integrated reagent/blood separation layer

Country Status (13)

Country Link
US (1) US6241862B1 (en)
EP (4) EP1155310B1 (en)
JP (1) JP3699898B2 (en)
CN (1) CN1241012C (en)
AT (2) ATE458996T1 (en)
AU (1) AU763723B2 (en)
BR (1) BR0008615B1 (en)
CA (1) CA2358464C (en)
DE (2) DE60043905D1 (en)
DK (1) DK1155310T3 (en)
ES (2) ES2255980T3 (en)
HK (1) HK1043832B (en)
WO (1) WO2000042422A1 (en)

Families Citing this family (302)

* Cited by examiner, † Cited by third party
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