Reduction of the hook effect in assay devices
First Claim
1. A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample, the flow-through assay device comprising:
- a porous membrane in communication with particles that are labeled with a signal-producing substance and conjugated with a specific binding member, the specific binding member being capable of preferentially binding to the analyte to form analyte/probe complexes, wherein the particles comprise pores that have an average size of less than about 100 nanometers and block the analyte/probe complexes but allow an uncomplexed analyte to pass therethrough, and further wherein the particles contain a hollow interior within which a domain is located, the domain non-specifically binding to the uncomplexed analyte that passes through the pores, the hollow interior constituting at least about 20% of the spatial volume occupied by the particle, wherein the particles comprise a shell polymer containing a nonionic ethylenically unsaturated monomer and an ethylenically unsaturated monomer that includes at least one carboxylic acid group;
wherein the porous membrane of the flow-through assay device defines a detection zone within which a receptive material is immobilized, the receptive material being configured to bind to the analyte/probe complexes, and further wherein the particles are capable of generating a detection signal when present within the detection zone that corresponds to the presence of the analyte within the test sample.
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Abstract
A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes conjugated probes that contain a specific binding member for the analyte of interest. The specific binding member preferentially complexes with the analyte within a test sample when contacted therewith. Excess analyte that remains uncomplexed with the specific binding member undergoes non-specific binding, such as to a hydrophobic domain. As a result, the ability of the uncomplexed analyte to compete with the complexed analyte at the detection zone of the device is restricted. Thus, the incidence of “false negatives” is limited in a simple, efficient, and relatively inexpensive manner.
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Citations
15 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, the flow-through assay device comprising:
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a porous membrane in communication with particles that are labeled with a signal-producing substance and conjugated with a specific binding member, the specific binding member being capable of preferentially binding to the analyte to form analyte/probe complexes, wherein the particles comprise pores that have an average size of less than about 100 nanometers and block the analyte/probe complexes but allow an uncomplexed analyte to pass therethrough, and further wherein the particles contain a hollow interior within which a domain is located, the domain non-specifically binding to the uncomplexed analyte that passes through the pores, the hollow interior constituting at least about 20% of the spatial volume occupied by the particle, wherein the particles comprise a shell polymer containing a nonionic ethylenically unsaturated monomer and an ethylenically unsaturated monomer that includes at least one carboxylic acid group; wherein the porous membrane of the flow-through assay device defines a detection zone within which a receptive material is immobilized, the receptive material being configured to bind to the analyte/probe complexes, and further wherein the particles are capable of generating a detection signal when present within the detection zone that corresponds to the presence of the analyte within the test sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification