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.
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Citations
149 Claims
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1-132. -132. (canceled)
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133. A biosensor, comprising:
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at least two plates, wherein at least one said plate includes a boundary area, wherein at least two plates form a tip region being tapered; at least four gold electrodes including at least two working electrodes, at least one counter or counter/reference electrode, wherein said electrodes are formed on at least one plate, wherein at least one electrode includes at least two tines, wherein at least one portion of other electrode is position at least substantially between said tines of said 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 (134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144)
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145. A method of using a biosensor, comprising:
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providing a biosensor having at least two said plates, wherein at least one said plate forms a boundary area, wherein at least two said plates form a tip region being tapered; forming at least four gold electrodes on at least one of said plates, wherein said electrodes include at least two working electrodes, at least one counter or counter/reference electrode, wherein at least one electrode includes at least two tines, wherein at least one portion of other electrode is position at least substantially between said tines of said electrode; forming a tip fill region associated with said boundary area for the transport of a biological fluid; forming a reagent layer including an enzyme-based composition, wherein said reagent layer is associated with at least one of said working electrodes; 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 (146, 147, 148)
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149. A biosensor, comprising:
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at least two plates, wherein at least one said plate forms a boundary area, wherein said boundary area receives a volume of biological fluid of no more than 1.0 μ
L, wherein at least two said plates form a tip region being tapered;at least four gold electrodes including at least two working electrodes, at least one counter or counter/reference electrode, wherein said electrodes are formed on at least said one plate, wherein at least one said electrode includes at least two tines, wherein at least one portion of other electrode is position at least substantially between said tines of said electrode, 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 including GDH-PQQ, wherein said reagent layer is associated with at least one of said working electrodes.
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Specification