US6565738B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Diagnostic test for the measurement of analyte in abiological fluid
Assignee: Abbott Laboratories
•
Filing: 1999-01-28
•
Granted: 2003-05-20
•
Expires: 2019-01-28
Abstract
Abstract A biosensor for determining the concentration of an analyte, such as, for example, ALT, in a sample of biological fluid, such as, for example, whole blood, comprising: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode being sufficiently smooth so that determination of the concentration of an analyte present in a low concentration, e.g., less than 1 mM, can be made; (c) a layer overlying said electrodes, said layer comprising dried reagents; and (d) an anticoagulant disposed in such a location that it will prevent the sample from coagulating during the determination. The biosensor preferably further includes a fluid-transporting layer to aid in delivering the sample from a sample application zone to the electrodes. The biosensor preferably further includes a covering layer overlying the electrode area to reduce evaporation of the sample during the assay and to help define the fluid transport path and the volume of fluid over the detecting layer.
Inventors
- 👤 Timothy P. Henning
- 👤 Kristen L. Cousineau
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 22:09
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54373; G01N33/5438; C; C12; C12Q; C12Q1/00; C12Q1/48; C12Q1/52
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
143 words
A biosensor for determining the concentration of an analyte in a sample of whole blood, said biosensor consisting essentially of: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode having a surface roughness not exceeding 10,000 Angstroms, wherein said surface roughness allows the determination of the concentration of an analyte present at a concentration of less than I mM in a sample of whole blood to be made; (c) a layer overlying said electrodes, said layer comprising at least one dried reagent; and (d) an anticoagulant disposed in such a location that it will prevent the sample of whole blood from coagulating during the determination, said biosensor further including a liquid-impermeable covering layer enclosing said electrodes to reduce evaporation of said sample of whole blood.
Claim 2
Dependent Claim
143 words
A biosensor for determining the concentration of an analyte in a sample of whole blood, said biosensor consisting essentially of: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode having a surface roughness not exceeding 10,000 Angstroms, wherein said surface roughness allows the determination of the concentration of an analyte present at a concentration of less than I mM in a sample of whole blood to be made; (c) a layer overlying said electrodes, said layer comprising at least one dried reagent; and (d) an anticoagulant disposed in such a location that it will prevent the sample of whole blood from coagulating during the determination, said biosensor further including a liquid-impermeable covering layer enclosing said electrodes to reduce evaporation of said sample of whole blood.
Claim 3
Dependent Claim
29 words
The biosensor of claim 1 , wherein said working electrode is made of a material selected from the group consisting of carbon, platinum, gold, palladium, silver chloride, and silver.
Claim 4
Dependent Claim
14 words
The biosensor of claim 1 , wherein said biosensor further includes a fluid-transporting layer.
Claim 5
Dependent Claim
14 words
The biosensor of claim 3 , wherein said fluid-transporting layer comprises a hydrophilic mesh.
Claim 6
Dependent Claim
15 words
The biosensor of claim 1 , wherein said working electrode further includes a redox polymer.
Claim 7
Dependent Claim
17 words
The biosensor of claim 1 , wherein said working electrode further includes a peroxidase enzyme and carbon.
Claim 8
Dependent Claim
17 words
The biosensor of claim 1 , wherein said working electrode does not dissolve upon exposure to fluid.
Claim 9
Dependent Claim
17 words
The biosensor of claim 1 , wherein said fluid is whole blood and said analyte is ALT.
Claim 10
Independent Claim
204 words
A method for determining the concentration of an analyte in a sample of whole blood, said method comprising the steps of: (1) providing a biosensor consisting essentially of: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode having a surface roughness not exceeding 10,000 Angstroms, wherein said surface roughness allows the determination of the concentration of an analyte present at a concentration of less than 1 mM in a sample of whole blood to be made; (c) a layer overlying said electrodes, said layer comprising at least one dried reagent; and (d) an anticoagulant disposed in such a location that it will prevent the sample of whole blood from coagulating during the determination, said biosensor further including a liquid-impermeable covering layer enclosing said electrodes to reduce evaporation of said sample of whole blood; (2) introducing a sample of whole blood to said biosensor; (3) allowing said sample of whole blood to dissolve said at least one dried reagent; (4) allowing a chemical reaction to occur at said detecting layer; and (5) reading the output of said chemical reaction, whereby the concentration of said analyte is determined.
Claim 11
Independent Claim
204 words
A method for determining the concentration of an analyte in a sample of whole blood, said method comprising the steps of: (1) providing a biosensor consisting essentially of: (a) a base layer; (b) a detecting layer comprising a reference electrode and a working electrode, the surface of the electrically conductive portion of the working electrode having a surface roughness not exceeding 10,000 Angstroms, wherein said surface roughness allows the determination of the concentration of an analyte present at a concentration of less than 1 mM in a sample of whole blood to be made; (c) a layer overlying said electrodes, said layer comprising at least one dried reagent; and (d) an anticoagulant disposed in such a location that it will prevent the sample of whole blood from coagulating during the determination, said biosensor further including a liquid-impermeable covering layer enclosing said electrodes to reduce evaporation of said sample of whole blood; (2) introducing a sample of whole blood to said biosensor; (3) allowing said sample of whole blood to dissolve said at least one dried reagent; (4) allowing a chemical reaction to occur at said detecting layer; and (5) reading the output of said chemical reaction, whereby the concentration of said analyte is determined.
Claim 12
Dependent Claim
29 words
The method of claim 9 , wherein said working electrode is made of a material selected from the group consisting of carbon, platinum, gold, palladium, silver chloride, and silver.
Claim 13
Dependent Claim
15 words
The method of claim 9 , wherein said biosensor further is includes a fluid-transporting layer.
Claim 14
Dependent Claim
14 words
The method of claim 11 , wherein said fluid-transporting layer comprises a hydrophilic mesh.
Claim 15
Dependent Claim
15 words
The method of claim 9 , wherein said working electrode further includes a redox polymer.
Claim 16
Dependent Claim
17 words
The method of claim 9 , wherein said working electrode further includes a peroxidase enzyme and carbon.
Claim 17
Dependent Claim
17 words
The method of claim 9 , wherein said working electrode does not dissolve upon exposure to fluid.
Claim 18
Dependent Claim
17 words
The method of claim 9 , wherein said fluid is whole blood and said analyte is ALT.
References Cited (Backward Citations)
DE248605C
Cited
DE247285C
Cited
US4240889A
Cited
US4897347A
Cited
US4450232A
Cited
US4575488A
Cited
EP0136362A1
Cited
US5682884A
Cited
JPS60344A
Cited
JPS61799A
Cited
GB2161274A
Cited
US5171689A
Cited
US4897173A
Cited
US4713165A
Cited
US5288636A
Cited
US5131999A
Cited
US5320732A
Cited
US5658444A
Cited
US5462858A
Cited
US5520787A
Cited
US5705045A
Cited
US5628890A
Cited
US5972199A
Cited
US5755953A
Cited
WO1998020331A1
Cited
WO1998024366A2
Cited
US6117289A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-05-19 | 2006-11-18 | 2007-05-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-05-19 | 2010-11-18 | 2011-05-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-05-19 | 2014-11-18 | 2015-05-20 | $7700.00 | Window Closed / Lapsed |