Small Volume In Vitro Analyte Sensor
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Accused Products
Abstract
A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 μL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as an enzyme, can be added to facilitate the electrooxidation or electroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable.
The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as amperometric, voltammetric, and potentiometric techniques, can also be used.
The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is provided as a second electron transfer agent.
208 Citations
170 Claims
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1-132. -132. (canceled)
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133. A biosensor for determining the concentration of an analyte, comprising:
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at least two plates, wherein at least one of said plates form at least one boundary area wherein a biological fluid is analyzed; at least one electrode extension having a contact region for connection with external electronics; a plurality of electrodes;
wherein at least one electrode is associated with at least one of said plates, wherein said plurality of electrodes includes at least one working electrode and at least one reference electrode, counter electrode and/or counter-reference electrode, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode; anda reagent layer including an enzyme-based composition. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145)
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146. A method of using a biosensor, comprising:
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providing a biosensor having at least two plates, wherein at least one of said plates includes forming a boundary area to house a biological fluid; forming at least two electrodes on at least one of said plates which are not in electrical contact with each other, wherein one electrode is a working electrode and one electrode is a reference electrode, counter electrode, or counter/reference electrode, wherein said reference electrode, counter electrode, or said counter/reference electrode includes at least two tines; forming at least one reagent layer is associated with at least one of said working electrodes and within boundary area; applying a biological fluid to said boundary area; flowing of said biological fluid by capillary action into said boundary area; detecting said biological fluid in said boundary area; measuring said biological fluid in said boundary area; and providing an actual concentration of said analyte in said biological fluid. - View Dependent Claims (147, 148)
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149. A biosensor for determining the concentration of an analyte, comprising:
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at least two plates, wherein at least one of said plates form at least one boundary area wherein a biological fluid is analyzed; at least one electrode extension having a contact region for connection with external electronics, wherein at least one of said electrode extensions is in the form of a tab; a plurality of electrodes;
wherein at least one electrode is associated with at least one of said plate, wherein said plurality of electrodes include at least one working electrode and at least one reference electrode, counter electrode and/or counter-reference electrode, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode; anda reagent layer including an enzyme-based composition, comprises glucose oxidase and ferricyanide, wherein said reagent layer associated with at least one of said working electrodes.
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150. A biosensor for determining the concentration of an analyte, comprising:
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at least two plates, wherein at least one of said plates include a boundary area; at least three electrodes including a working electrode and a reference electrode, counter electrode, or counter/reference electrode, wherein said electrodes are formed on at least one of said plates, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode; a tip fill region associated with said boundary area for the transport of a biological fluid; and a reagent layer including an enzyme-based composition, wherein said reagent layer is associated with at least one of said working electrodes. - View Dependent Claims (151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167)
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168. A method for using a biosensor, comprising:
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at least two plates, wherein at least one of said plates includes a boundary area; at least three electrodes including a working electrode and a reference electrode, counter electrode, or counter/reference electrode, wherein said electrodes are formed on at least one of said plate, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode; a tip fill region associated with said boundary area for the transport of a biological fluid, wherein said tip region is tapered; and a reagent layer including an enzyme-based composition, wherein said reagent layer is associated with at least one of said working electrodes.
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169. A biosensor for determining the concentration of an analyte, comprising:
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at least two plates, wherein at least one of said plates includes a boundary area receiving a volume of a biological fluid of no more than 1 μ
L;at least three electrodes including a working electrode and a reference electrode, counter electrode, or counter/reference electrode, wherein said electrodes are formed on at least one of said plate, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode, wherein at least one of said tine is in the shape of the letter C; a tip fill region associated with said boundary area for the transport of a biological fluid; and a reagent layer including an enzyme-based composition including GDH or GDH-PQQ, wherein said reagent layer is associated with at least one of said working electrodes.
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170. A biosensor for determining the concentration of an analyte, comprising:
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at least two plates, wherein at least one said plate includes a boundary area; at least three electrodes including a working electrode and a reference electrode, counter electrode, or counter/reference electrode, wherein said electrodes are formed on at least one of said plate, wherein said reference electrode, counter electrode, or counter/reference electrode includes at least two tines, wherein one tine is downstream of said working electrode and one tine is upstream of said working electrode, wherein at least one of said tine is in the shape of the letter C; a tip fill region associated with said boundary area for the transport of a biological fluid, wherein said tip region is tapered; and a reagent layer including an enzyme-based composition including glucose oxidase, wherein said reagent layer is associated with at least one of said working electrodes.
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Specification