Flow-through assay devices
First Claim
1. A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a fluidic medium in communication with an electrochemical affinity biosensor, said biosensor comprising:
- a detection working electrode capable of generating a measurable detection current, wherein a specific binding capture ligand for the analyte is applied to said detection working electrode; and
a calibration working electrode capable of generating a measurable calibration current, wherein the amount of the analyte within the test sample is determined by calibration of the detection current with the calibration current.
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Abstract
A flow-through assay device capable of detecting the presence or quantity of an analyte of interest is provided. The device is in communication with an electrochemical biosensor that utilizes detection and calibration working electrodes that communicate with affinity reagents, such as redox mediators and capture ligands. For instance, capture ligands that are specific binding members for the analyte of interest may be applied to the detection electrode to serve as the primary location for detection of the analyte. The calibration working electrode may be used to calibrate the detection working electrode for any intrinsic background current not generated by the reagents of the biosensor system. Moreover, capture ligands that are non-specific binding members for the analyte of interest may also be applied to the calibration electrode. In such instances, the calibration electrode may be used to calibrate the detection working electrode for any non-specific binding that may contribute to the current generated on the surface thereof.
205 Citations
46 Claims
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1. A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a fluidic medium in communication with an electrochemical affinity biosensor, said biosensor comprising:
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a detection working electrode capable of generating a measurable detection current, wherein a specific binding capture ligand for the analyte is applied to said detection working electrode; and
a calibration working electrode capable of generating a measurable calibration current, wherein the amount of the analyte within the test sample is determined by calibration of the detection current with the calibration current. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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- 22. A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample, said flow-through assay device comprising a fluidic medium, wherein a redox label is applied to said fluidic medium for directly or indirectly binding to the analyte, said fluidic medium being in communication with an electrochemical affinity biosensor strip, said biosensor strip comprising an insulative substrate on which a detection working electrode capable of generating a measurable detection current and a calibration working electrode capable of generating a measurable calibration current are formed, wherein a specific binding capture ligand for the analyte is immobilized on said detection working electrode, the amount of the analyte within the test sample being determined by calibration of the detection current with the calibration current.
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33. A method for detecting the presence or quantity of an analyte residing in a test sample, said method comprising:
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i) providing a flow-through assay device comprising a fluidic medium in communication with an electrochemical affinity biosensor, said biosensor comprising a detection working electrode on which is immobilized a specific binding capture ligand for the analyte and a calibration working electrode;
ii) contacting a test sample containing the analyte with said fluidic medium;
iii) allowing the test sample to flow through said fluidic medium to contact said detection working electrode and said calibration working electrode;
iv) applying a potential difference between said detection working electrode and a counter electrode and between said calibration working electrode and a counter electrode;
v) measuring the current generated at the detection working electrode and the current generated at the calibration working electrode;
vi) determining a calibrated detection current by calibrating the current generated at the detection working electrode by the current generated at the calibration working electrode; and
vii) correlating the calibrated detection current to a concentration for the analyte. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
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Specification