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Publication Number
US-8951749-B2
Publication Date
2015-02-10
Expiration Date
Abstract
Disclosed herein are devices for detecting the presence of a target analyte in a fluid sample. The biosensor device can comprise at least a reaction chamber and a detection chamber. The device can comprise a amplifying mechanism such that one target analyte molecule present in the fluid sample can lead to generation/activation of multiple detection agent molecules, and therefore, an amplified signal. Also disclosed are the methods of manufacturing and using such a biosensor device.
Core Innovation
The invention provides an enhanced immunoassay biosensor device for detecting a target analyte in a fluid sample. A reaction chamber includes internal surfaces, a binding agent and a probe agent, where the probe agent comprises a binding partner and a vehicle and the binding partner is bound to the vehicle.
The vehicle comprises a plurality of copies of an activating agent, and target analyte binding is configured to change the amount of probe agent that moves downstream. A detection chamber comprises a detecting agent, where the activating agent can activate the detecting agent, and a fluid passageway between the reaction chamber and the detection chamber moves the reacted fluid sample via capillary action.
The presence of the target analyte in the fluid sample results in a change in the amount of probe agent that moves to the detection chamber, and the change is detectable in the detection chamber and dependent on at least a threshold of the concentration. The document further discloses activating-cofactor–apoenzyme chemistry, including PQQ- or FAD-based systems with apo-glucose dehydrogenase or apo-glucose oxidase, optional liberating agents, and structural embodiments including reaction/detection chamber geometries, multilayer strip formats, vents, and fluid handling features.
Claims Coverage
The independent claim defines a device with reaction and detection chambers linked by a capillary-driven fluid passageway, where target analyte binding controls the downstream amount of probe agent to produce a detectable, threshold-dependent signal. The claim set includes multiple refinements that constrain activating and detecting activation chemistry, mediator and electrode detection elements, and optional mechanisms such as liberation of activating agent, vehicle and copy-number constraints, and fluid-handling features.
Capillary-moved reacted sample linking reaction and detection chambers
A reaction chamber reacts a target analyte with a binding agent or binding partner, and a fluid passageway between the reaction chamber and the detection chamber moves the reacted fluid sample via capillary action.
Vehicle carrying plurality of activating agent copies on probe agent
The probe agent comprises a binding partner and a vehicle, wherein the binding partner is bound to the vehicle and the vehicle comprises a plurality of copies of an activating agent.
Activating agent activates a detecting agent in detection chamber
The detection chamber comprises a detecting agent, wherein the activating agent can activate the detecting agent.
Target-analyte concentration changes moved probe agent amount detectable at threshold
Presence of the target analyte at a concentration results in a change in the amount of probe agent that moves with the reacted fluid sample to the detection chamber, where the change is detectable and dependent on at least a threshold of the concentration.
Cofactor–apoenzyme activation chemistry in detection activation
A cofactor comprising flavin adenine dinucleotide (FAD) and an apoenzyme comprising apo-glucose oxidase is used.
Activating agent copy-number constraint in the vehicle
The vehicle contains approximately between 10 and 100000 copies of an activating agent.
Mediator substances in the detection chamber for activation readout
A detection chamber further comprises at least one mediator substance selected from dichlorophenolindophenol, phenazine ethosulphate, ferricyanide, ferrocene, and complexes between transition metals and nitrogen-containing heteroatomic species.
Electrochemical detection using electrodes in the detection chamber
The detection chamber further comprises at least two electrodes to detect an electrochemical reaction.
Liberating agent releases activating agent from vehicle in detection chamber
The device includes a detection chamber further comprising a liberating agent that releases the activating agent from its vehicle.
Across the independent claim and its listed refinements, the central inventive structure is a two-chamber immunoassay device where capillary action transports a reacted sample to a downstream detection chamber, and target analyte binding controls the amount of vehicle-carried activating agent or probe agent reaching the detector to yield a detectable threshold-dependent change. Refinements specify activation chemistry, mediator selection, electrochemical electrode-based detection, activating-agent copy-number in the vehicle, and optional liberation of activating agent from the vehicle in the detection chamber.
Stated Advantages
Produces a detectable change in the amount of probe agent moved to the detection chamber dependent on at least a threshold of the target analyte concentration.
Documented Applications
Detecting a target analyte in a fluid sample using an enhanced immunoassay biosensor device having reaction and detection chambers connected by a capillary action fluid passageway.
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