Diagnostic devices and apparatus for the controlled movement of reagents without membranes
First Claim
1. An assay device comprising:
- a housing;
a first device region formed by or within said housing for receiving a fluid sample; and
a second device region fluidly connected to said first device region, said second device region comprising one or more capture zones on a surface within said housing, each said capture zone comprising molecules of a first receptor reactive with an analyte of interest and at least one analyte sensor configured and arranged to detect an electrochemical signal related to reaction of a detectable amount of said analyte of interest with molecules of said first receptor and produce a measurable signal in response;
wherein said assay device is configured and arranged to deliver a predetermined volume of said fluid sample from said first device region to said second device region for determining the presence or amount of one or more analytes of interest therein.
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Accused Products
Abstract
The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.
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Citations
24 Claims
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1. An assay device comprising:
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a housing;
a first device region formed by or within said housing for receiving a fluid sample; and
a second device region fluidly connected to said first device region, said second device region comprising one or more capture zones on a surface within said housing, each said capture zone comprising molecules of a first receptor reactive with an analyte of interest and at least one analyte sensor configured and arranged to detect an electrochemical signal related to reaction of a detectable amount of said analyte of interest with molecules of said first receptor and produce a measurable signal in response;
wherein said assay device is configured and arranged to deliver a predetermined volume of said fluid sample from said first device region to said second device region for determining the presence or amount of one or more analytes of interest therein. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An assay device comprising:
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a housing;
a first device region formed by or within said housing for receiving a fluid sample;
a second device region fluidly connected to said first device region, said second device region comprising one or more capture zones on a surface within said housing, each said capture zone comprising molecules of a first antibody or binding fragment thereof reactive with an analyte of interest and at least one analyte sensor configured and arranged to detect an electrochemical signal related to reaction of a detectable amount of said analyte of interest with molecules of said first antibody or binding fragment thereof and produce a measurable signal in response; and
a labeled reagent species dissolvably disposed on a surface within said housing that is in fluid communication with said second device region, wherein molecules of said labeled reagent species comprise an enzyme conjugated to a second antibody or binding fragment thereof reactive with said analyte of interest, wherein molecules of said labeled reagent species form sandwich complexes with molecules of said analyte of interest and with molecules of said first antibody or binding fragment thereof. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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18. A method for detecting an analyte of interest in a fluid sample, comprising:
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introducing said fluid sample into a device comprising;
a housing;
a first device region formed by or within said housing for receiving a fluid sample; and
a second device region fluidly connected to said first device region, said second device region comprising a capture zone on a surface within said housing, said capture zone comprising molecules of a first receptor reactive with said analyte of interest and at least one analyte sensor configured and arranged to detect an electrochemical signal related to reaction of a detectable amount of analyte with molecules of said first receptor and produce a measurable signal in response;
delivering a volume of said fluid sample from said first device region to said second device region, wherein molecules of said analyte present in said volume react with molecules of said first receptor at said capture zone;
contacting said analyte of interest with molecules of a labeled reagent species, wherein said labeled reagent species comprises an enzyme conjugated to a second receptor reactive with said analyte of interest, wherein molecules of said labeled reagent species form sandwich complexes with molecules of said analyte of interest and with molecules of said first receptor at said capture zone;
contacting said sandwich complexes with molecules of a substrate for said enzyme; and
measuring a signal produced by said analyte sensor. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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Specification