APPARATUS AND METHODS FOR ANALYTE MEASUREMENT AND IMMUNOASSAY
First Claim
1. A cartridge for sensing at least one analyte in a sample, said cartridge comprising:
- a sample holding chamber for receiving said sample and retaining said sample;
a first conduit connected to said sample holding chamber;
at least one analyte sensor, wherein said sensor comprises an analyte-responsive surface and said surface is within said first conduit;
a second conduit for retaining a fluid, said second conduit connected to said first conduit at a junction;
means for inserting at least one air segment into said first or second conduit;
pump means capable of displacing said sample from said holding chamber into said first conduit, said pump means further capable of displacing said fluid from said second conduit into said first conduit; and
an analyte sensor comprising a microfabricated base sensor with a bioactive layer, superimposed over at least a portion of said base sensor, said layer comprising a sufficient amount of a biomolecules attached thereto, wherein said biomolecule is sensitive to said analyte.
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Accused Products
Abstract
The present invention relates to an apparatus for conducting a variety of assays for the determination of analytes in liquid samples, and relates to the methods for such assays. In particular, the invention relates to a single-use cartridge designed to be adaptable to a variety of real-time assay protocols, preferably assays for the determination of analytes in biological samples using immunosensors or other ligand/ligand receptor-based biosensor embodiments. The cartridge provides novel features for processing a metered portion of a sample, for precise and flexible control of the movement of a sample or second fluid within the cartridge, for the amending of solutions with additional compounds during an assay, and for the construction of immunosensors capable of adaptation to diverse analyte measurements. The disclosed device and methods of use enjoy substantial benefits over the prior art, including simplicity of use by an operator, rapid in situ determinations of one or more analytes, and single-use methodology that minimizes the risk of contamination of both operator and patient. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments.
59 Citations
25 Claims
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1. A cartridge for sensing at least one analyte in a sample, said cartridge comprising:
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a sample holding chamber for receiving said sample and retaining said sample; a first conduit connected to said sample holding chamber; at least one analyte sensor, wherein said sensor comprises an analyte-responsive surface and said surface is within said first conduit; a second conduit for retaining a fluid, said second conduit connected to said first conduit at a junction; means for inserting at least one air segment into said first or second conduit; pump means capable of displacing said sample from said holding chamber into said first conduit, said pump means further capable of displacing said fluid from said second conduit into said first conduit; and an analyte sensor comprising a microfabricated base sensor with a bioactive layer, superimposed over at least a portion of said base sensor, said layer comprising a sufficient amount of a biomolecules attached thereto, wherein said biomolecule is sensitive to said analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A cartridge for sensing at least one analyte in a sample, said cartridge comprising:
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a sample holding chamber for receiving said sample and retaining said sample; a first conduit connected to said sample holding chamber; at least one analyte sensor, wherein said sensor comprises an analyte-responsive surface and said surface is within said first conduit; a first and second vent within said first conduit wherein said sensor is positioned between said sample chamber and said vents; a second conduit for retaining a fluid, said second conduit connected to said first conduit between said sample chamber and said vents; pump means capable of displacing said sample from said holding chamber into said first conduit and further capable of closing said second vent to retain said sample in the region of said second vent; and wherein said pump means is further capable of displacing said fluid from said second conduit into said first conduit, and wherein said first vent permits at least one air segment to enter said fluid. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of measuring the amount of an analyte using an electrochemical assay in a conduit comprising a sensor, wherein said sensor comprises an electrode having a surface layer of immobilized antibody that binds said analyte, and a counter/reference electrode disposed within said conduit, said method comprising:
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contacting said sensor with a liquid sample containing said analyte; contacting said sensor with an enzyme-labeled antibody capable of binding said analyte, whereby a complex of immobilized antibody, analyte and labeled antibody is formed; contacting said sensor with a solution comprising a substrate for said enzyme and at least one air segment to remove unbound analyte and labeled antibody from said sensor region; removing substantially all said fluid from said sensor while retaining said fluid over said electrode, said counter/reference electrode, and a contiguous portion of the wall connecting said electrodes; and detecting the product of the reaction between said enzyme and said substrate using said sensor, whereby the amount of analyte in the liquid sample is measured. - View Dependent Claims (22, 23, 24, 25)
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Specification