CA2481425A1 - Disposable sensor with enhanced sample port inlet - Google Patents
Disposable sensor with enhanced sample port inlet Download PDFInfo
- Publication number
- CA2481425A1 CA2481425A1 CA002481425A CA2481425A CA2481425A1 CA 2481425 A1 CA2481425 A1 CA 2481425A1 CA 002481425 A CA002481425 A CA 002481425A CA 2481425 A CA2481425 A CA 2481425A CA 2481425 A1 CA2481425 A1 CA 2481425A1
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- CA
- Canada
- Prior art keywords
- layer
- reagent
- strip
- electrode
- forming
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- 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.)
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Classifications
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- 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
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- 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
Abstract
A disposable biosensor for testing a fluid sample including a laminated stri p with a first and second end, a reference electrode embedded in the laminated strip proximate to the first end, at least one working electrode embedded in the laminated strip proximate to the first end and the reference electrode, an open path for receiving a fluid sample beginning from the first end and connecting to a vent spaced from the first end, the open path being sufficiently long to expose the reference electrode and the working electrod e to the fluid sample, and conductive contacts located at the second end of th e laminated strip. The laminated strip has a base layer with a conductive coating, a reagent holding layer, a channel forming layer and a cover having an inlet notch at the first end. The working electrode contains a reagent having an enzyme.
Claims (30)
1. A disposable biosensor comprising:
a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer with a conductive coating disposed thereon, said base layer having at least two electrodes delineated thereon, a reagent holding layer carried on said base layer, said reagent holding layer having at least two cutouts, a channel forming layer carried on said reagent holding layer, and a cover having a notch at said first strip end;
an enclosed channel between said first strip end and said vent opening, said enclosed channel containing said at least two cutouts;
a reagent disposed in said at least two cutouts forming a first working electrode and a reference electrode, said reagent containing an enzyme; and conductive contacts at said second strip end and insulated from said enclosed channel.
a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer with a conductive coating disposed thereon, said base layer having at least two electrodes delineated thereon, a reagent holding layer carried on said base layer, said reagent holding layer having at least two cutouts, a channel forming layer carried on said reagent holding layer, and a cover having a notch at said first strip end;
an enclosed channel between said first strip end and said vent opening, said enclosed channel containing said at least two cutouts;
a reagent disposed in said at least two cutouts forming a first working electrode and a reference electrode, said reagent containing an enzyme; and conductive contacts at said second strip end and insulated from said enclosed channel.
2. The biosensor of Claim 1 wherein said enzyme is selected from the group consisting of glucose oxidase, lactate oxidase, cholesterol oxidase, and creatinine amidohydrolase.
3. The biosensor of Claim 1 wherein said reagent holding layer has a third cutout having said reagent disposed therein and forming a second working electrode.
4. The biosensor of Claim 1 wherein said reagent further contains at least one of a redox mediator, a stabilizer, a binder, a surfactant, and a buffer.
5. The biosensor of Claim 4 wherein said stabilizer is a polyalkylene glycol, said binder is a cellulose material, and said surfactant is a polyoxyethylene ether.
6. The biosensor of Claim 5 wherein said stabilizer is polyethylene glycol, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.
7. The biosensor of Claim 6 wherein said reagent is made from a mixture having starting components comprising about 1wt% to about 6.5wt% of said redox mediator, about 2.5wt% of said stabilizer, about 1wt% of said binder, and about .03wt% of said surfactant in said buffer.
8. The biosensor of Claim 7 wherein said citrate buffer is about 0.05M.
9. The biosensor of Claim 4 wherein said redox mediator is at least one of potassium ferricyanide and other inorganic and organic redox mediators.
10. The biosensor of Claim 1 wherein said conductive coating is gold or a gold and tin oxide mix.
11. The biosensor of Claim 1 wherein said base layer, said reagent holding layer, said channel forming layer, and said cover are made of a plastic dielectric material.
12. The biosensor of Claim 1 wherein said channel forming layer has a thickness sufficient to optimize the flow of said fluid sample along said open path.
13. The biosensor of Claim 7 wherein said reagent forming said reference electrode is made of a mixture having starting components comprising about 1wt% of said potassium ferricyanide, about 2.5wt% of said polyethylene glycol, about 1wt% of said methyl cellulose, about .03wt% of said t-octylphenoxypolyethoxyethanol, and said citrate buffer is about 0.05M.
14. The biosensor of Claim 9 wherein said reagent of said first working electrode is made of a mixture having starting components comprising about 6.5wt% of said potassium ferricyanide, about 2.5wt% of said polyethylene glycol, about 1wt% of said methyl cellulose, about .03wt% of said t-octylphenoxypolyethoxyethanol, and said pH buffer is about a 0.05M citrate buffer, and about 1wt% of said enzyme.
15. The biosensor of Claim 14 wherein said enzyme is glucose oxidase.
16. The biosensor of Claim 3 wherein the surface area of said first working electrode is substantially same as the surface area of said second working electrode.
17. The biosensor of Claim 3 wherein said reagent forming said second working electrode is substantially similar to said reagent forming said reference electrode.
18. A disposable electrode strip for detecting or measuring the concentration of at least one analyte in a fluid sample, said electrode strip comprising:
an insulating base layer having a first base end and a second base end;
a conductive layer disposed on one side of said base layer delineating at least three electrically-distinct conductive paths insulated from each other;
a reagent holding layer sized smaller than said base layer and overlaying a substantial portion of said conductive layer, said reagent holding layer having at least a first cutout portion and a second cutout portion spaced from said first base end, said first cutout portion exposing a limited area of a first of said at least three conductive paths and said second cutout portion exposing a limited area of a second and a third of said at least three conductive paths;
at least two electrode materials wherein a first electrode material is a reagent for measuring the concentration of said at least one analyte and wherein a second electrode material is a material suitable for use as a reference material, each of said at least two electrode materials contains at least a polyalkylene glycol as a stabilizer, said first material being disposed in said first cutout potion and said second material being disposed in said second cutout portion;
a channel forming layer sized to fit over and coextensive with said reagent holding layer, said channel forming layer having an opening configured to expose an area of said reagent holding layer a limited distance from said first base end, said area including said at least two cutout portions of said reagent holding layer; and a top layer sized to fit over and coextensive with said channel forming layer creating a sample fluid channel, said top layer having an inlet notch at a first top layer end, said first top layer end being coextensive with said first base end, and a top layer vent spaced from said first base end and configured to expose at least a small portion of said opening of said channel forming layer.
an insulating base layer having a first base end and a second base end;
a conductive layer disposed on one side of said base layer delineating at least three electrically-distinct conductive paths insulated from each other;
a reagent holding layer sized smaller than said base layer and overlaying a substantial portion of said conductive layer, said reagent holding layer having at least a first cutout portion and a second cutout portion spaced from said first base end, said first cutout portion exposing a limited area of a first of said at least three conductive paths and said second cutout portion exposing a limited area of a second and a third of said at least three conductive paths;
at least two electrode materials wherein a first electrode material is a reagent for measuring the concentration of said at least one analyte and wherein a second electrode material is a material suitable for use as a reference material, each of said at least two electrode materials contains at least a polyalkylene glycol as a stabilizer, said first material being disposed in said first cutout potion and said second material being disposed in said second cutout portion;
a channel forming layer sized to fit over and coextensive with said reagent holding layer, said channel forming layer having an opening configured to expose an area of said reagent holding layer a limited distance from said first base end, said area including said at least two cutout portions of said reagent holding layer; and a top layer sized to fit over and coextensive with said channel forming layer creating a sample fluid channel, said top layer having an inlet notch at a first top layer end, said first top layer end being coextensive with said first base end, and a top layer vent spaced from said first base end and configured to expose at least a small portion of said opening of said channel forming layer.
19. The strip of Claim 18 wherein said sample fluid channel is hydrophilic.
20. The device of Claim 18 wherein said first material and said second material further include a redox mediator, a binder, a surfactant, and a buffer.
21. The strip of Claim 20 wherein said redox mediator is at least one metal complex selected from the group consisting of ferrocene, ferrocene derivatives and potassium ferricyanide, said binder is a cellulose material, said surfactant is a polyoxyethylene ether, and said buffer has a pH of about to about 6.
22. The strip of Claim 21 wherein said mediator is potassium ferricyanide, said stabilizer is polyethylene glycol, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.
23. The strip of Claim 22 wherein said first electrode material is made of a mixture having starting components comprising about 1wt% of said potassium ferricyanide, about 2.5wt% of said polyethylene glycol, about 1wt% of said methyl cellulose, and about 0.03wt% of said t-octylphenoxypolyethoxyethanol in said citrate buffer.
24. The strip of Claim 22 wherein said second electrode material is made of a mixture having starting components comprising about 6.5wt% of said potassium ferricyanide, about 2.5wt% of said polyethylene glycol, about 1wt% of said methyl cellulose, about 0.03wt% of said t-octylphenoxypolyethoxyethanol, and about 1wt% of an enzyme in said citrate buffer.
25. The strip of Claim 24 wherein said enzyme is glucose oxidase.
26. A method of making a disposable biosensor comprising:
scribing a conductive coating disposed on one side of an elongated base layer having an electrode end and an electrical contact end forming at least two elongated electrical conduits along the length of said base layer wherein a first conduit of said at least two electrical conduits has an L-shape wherein the L-shaped portion of said first conduit is adjacent said second conduit wherein said L-shaped end of said first conduit and a portion of said second conduit are located near said electrode end;
adhering a reagent holding layer over said base layer that is shorter than the length of said base layer such that a portion of each of said at least two elongated conduits is exposed at said electrical contact end, said reagent holding layer having at least two reagent holding cutouts spaced from said electrode end wherein a first cutout exposes a portion of said first conduit and a second cutout exposes a portion of said second conduit;
adding a reagent mixture to said first cutout forming a reference electrode and said second cutout forming a first working electrode, said reagent mixture in at least said first working electrode having an enzyme capable of catalyzing a reaction involving a substrate for the enzyme;
drying said reagent mixture forming a reagent matrix;
disposing a channel forming layer over said reagent holding layer, said channel forming layer having a U-shaped end portion defining a central elongated channel sized to expose said at least two reagent cutouts of said reagent holding layer; and disposing a top layer over said channel forming layer, said top layer having a vent opening spaced from said electrode end and a notch at said electrode end, said top layer forming an inlet and a capillary space with said U-shaped end portion wherein said vent exposes a portion of said central channel at the end of said capillary space opposite said inlet and said notch exposes a portion of said central channel at said inlet.
scribing a conductive coating disposed on one side of an elongated base layer having an electrode end and an electrical contact end forming at least two elongated electrical conduits along the length of said base layer wherein a first conduit of said at least two electrical conduits has an L-shape wherein the L-shaped portion of said first conduit is adjacent said second conduit wherein said L-shaped end of said first conduit and a portion of said second conduit are located near said electrode end;
adhering a reagent holding layer over said base layer that is shorter than the length of said base layer such that a portion of each of said at least two elongated conduits is exposed at said electrical contact end, said reagent holding layer having at least two reagent holding cutouts spaced from said electrode end wherein a first cutout exposes a portion of said first conduit and a second cutout exposes a portion of said second conduit;
adding a reagent mixture to said first cutout forming a reference electrode and said second cutout forming a first working electrode, said reagent mixture in at least said first working electrode having an enzyme capable of catalyzing a reaction involving a substrate for the enzyme;
drying said reagent mixture forming a reagent matrix;
disposing a channel forming layer over said reagent holding layer, said channel forming layer having a U-shaped end portion defining a central elongated channel sized to expose said at least two reagent cutouts of said reagent holding layer; and disposing a top layer over said channel forming layer, said top layer having a vent opening spaced from said electrode end and a notch at said electrode end, said top layer forming an inlet and a capillary space with said U-shaped end portion wherein said vent exposes a portion of said central channel at the end of said capillary space opposite said inlet and said notch exposes a portion of said central channel at said inlet.
27. The method of Claim 26 further comprising mixing a redox mediator, a stabilizer, a binder, a surfactant and a buffer forming said reagent mixture.
28. A method of making multiple, disposable sensors wherein each sensor has at least a first working electrode and a reference electrode, wherein said first working electrode contains an enzyme capable of catalyzing a reaction involving a substrate for the enzyme, said at least a first working electrode and said reference electrode being disposed in a fluid sample channel for measuring a fluid sample, said method comprising:
obtaining a base strip of an insulating material having a layer of conductive material disposed thereon, said base strip having a first edge and a second edge;
scribing in said conductive material a plurality of lines in a repetitive pattern wherein said plurality of lines contain a repetitive pattern forming three conductive paths in each of said repetitive pattern;
disposing a first middle layer of insulating material over said base strip, said first middle layer having a repetitive pattern of at least two cutouts wherein each cutout of each of said repetitive pattern exposes at least an electrode portion of said conductive layer wherein said repetitive pattern of said at least two cutouts are spaced from said first edge of said base strip, and wherein said first middle layer is sized to expose a contact portion of each of said three conductive paths of each repetitive pattern for a distance from said second edge of said base strip;
disposing a first reagent material on one of said at least two cutouts of each repetitive pattern and a second reagent material on the other of said at least two cutouts of each repetitive pattern;
drying said first reagent material and said second reagent material;
overlaying a second middle insulating layer over and coextensive with said first middle layer, said second middle layer having a plurality of elongated cutout portions in a repetitive pattern wherein each of said elongated cutout portions exposes a corresponding repetitive pattern of said at least two cutouts of said first middle layer;
disposing a top layer of insulating material over and coextensive with said second middle layer, said top layer having a plurality of vent openings and notch forming holes in a repetitive pattern wherein each of said vent openings exposes a portion of a corresponding repetitive pattern of said elongated cutout portion furthest from said first edge of said base strip and wherein each of said notch forming holes exposes a portion of said corresponding repetitive pattern of said elongated cutout portion closest to said first edge of said base strip, said base strip, said first middle layer, said second middle layer, and said top layer forming a laminated strip;
cutting along and parallel to said first edge of said laminated strip a predetermined distance creating a sample inlet port in each of said elongated cutout and an inlet notch in said top layer for each of said repetitive pattern;
cutting along and parallel to said second edge of said laminated strip a predetermined distance creating three separate contacts for each of said repetitive pattern; and separating each of said repetitive pattern forming one of each of said disposable sensors.
obtaining a base strip of an insulating material having a layer of conductive material disposed thereon, said base strip having a first edge and a second edge;
scribing in said conductive material a plurality of lines in a repetitive pattern wherein said plurality of lines contain a repetitive pattern forming three conductive paths in each of said repetitive pattern;
disposing a first middle layer of insulating material over said base strip, said first middle layer having a repetitive pattern of at least two cutouts wherein each cutout of each of said repetitive pattern exposes at least an electrode portion of said conductive layer wherein said repetitive pattern of said at least two cutouts are spaced from said first edge of said base strip, and wherein said first middle layer is sized to expose a contact portion of each of said three conductive paths of each repetitive pattern for a distance from said second edge of said base strip;
disposing a first reagent material on one of said at least two cutouts of each repetitive pattern and a second reagent material on the other of said at least two cutouts of each repetitive pattern;
drying said first reagent material and said second reagent material;
overlaying a second middle insulating layer over and coextensive with said first middle layer, said second middle layer having a plurality of elongated cutout portions in a repetitive pattern wherein each of said elongated cutout portions exposes a corresponding repetitive pattern of said at least two cutouts of said first middle layer;
disposing a top layer of insulating material over and coextensive with said second middle layer, said top layer having a plurality of vent openings and notch forming holes in a repetitive pattern wherein each of said vent openings exposes a portion of a corresponding repetitive pattern of said elongated cutout portion furthest from said first edge of said base strip and wherein each of said notch forming holes exposes a portion of said corresponding repetitive pattern of said elongated cutout portion closest to said first edge of said base strip, said base strip, said first middle layer, said second middle layer, and said top layer forming a laminated strip;
cutting along and parallel to said first edge of said laminated strip a predetermined distance creating a sample inlet port in each of said elongated cutout and an inlet notch in said top layer for each of said repetitive pattern;
cutting along and parallel to said second edge of said laminated strip a predetermined distance creating three separate contacts for each of said repetitive pattern; and separating each of said repetitive pattern forming one of each of said disposable sensors.
29. The method of Claim 28 further comprising drying said first reagent material and said second reagent material at a temperature and for a length of time sufficient to allow said first reagent material and said second reagent material to solidify and adhere to each of said electrode portion of each of said repetitive pattern of said three conductive paths.
30. The method of Claim 28 further comprising mixing a redox mediator, a stabilizer, a binder, a surfactant and a buffer forming said first reagent material, and mixing a redox mediator, a stabilizer, a binder, a surfactant, a buffer, and an enzyme forming said second reagent material.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/126,819 US6837976B2 (en) | 2002-04-19 | 2002-04-19 | Disposable sensor with enhanced sample port inlet |
US10/126,819 | 2002-04-19 | ||
PCT/US2003/011554 WO2003089658A1 (en) | 2002-04-19 | 2003-04-16 | Disposable sensor with enhanced sample port inlet |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2481425A1 true CA2481425A1 (en) | 2003-10-30 |
CA2481425C CA2481425C (en) | 2010-03-16 |
Family
ID=29248425
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2481425A Expired - Lifetime CA2481425C (en) | 2002-04-19 | 2003-04-16 | Disposable sensor with enhanced sample port inlet |
Country Status (8)
Country | Link |
---|---|
US (1) | US6837976B2 (en) |
EP (1) | EP1497449B1 (en) |
JP (1) | JP4620356B2 (en) |
AU (1) | AU2003228535A1 (en) |
CA (1) | CA2481425C (en) |
DE (1) | DE60319973T2 (en) |
ES (1) | ES2302927T3 (en) |
WO (1) | WO2003089658A1 (en) |
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EP1497449B1 (en) | 2008-03-26 |
AU2003228535A1 (en) | 2003-11-03 |
US6837976B2 (en) | 2005-01-04 |
JP4620356B2 (en) | 2011-01-26 |
DE60319973D1 (en) | 2008-05-08 |
WO2003089658A1 (en) | 2003-10-30 |
CA2481425C (en) | 2010-03-16 |
EP1497449A1 (en) | 2005-01-19 |
ES2302927T3 (en) | 2008-08-01 |
DE60319973T2 (en) | 2009-04-16 |
US20040224369A1 (en) | 2004-11-11 |
JP2005523443A (en) | 2005-08-04 |
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