Diagnostic test for the measurement of analyte in abiological fluid
First Claim
1. 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.
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Accused Products
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.
140 Citations
16 Claims
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1. A biosensor for determining the concentration of an analyte in a sample of whole blood, said biosensor consisting essentially of:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for determining the concentration of an analyte in a sample of whole blood, said method comprising the steps of:
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(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. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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Specification