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Devices and methods utilizing arrays of structures for analyte capture

Assignee: Abbott Laboratories
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Filing: 1994-09-30
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Granted: 1998-01-13
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Expires: 2014-09-30
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Abstract

Abstract The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Inventors

  • 👤 Douglas D. Hansmann
  • 👤 John P. Grace
  • 👤 Michael G. Lowery
  • 👤 Gary M. Oosta
  • 👤 Neil W. Loomis
  • 👤 Eric B. Shain
  • 👤 Thomas G. Schapira

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-07 02:38
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/5302; G01N33/5304; B; B01; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5027; B01L3/502753; C; C08; C08G; C08G18/00; C08G18/06; C08G18/08; C08G18/0838; C08G18/0842; C08G18/0861; C08G18/0866; C08G18/10; G01N33/543; G01N33/54366; G01N33/54393; B01L2200/00; B01L2200/10; B01L2300/00; B01L2300/06; B01L2300/0627; B01L2300/0636; B01L2300/08; B01L2300/0809; B01L2300/0825; B01L2400/00; B01L2400/04; B01L2400/0403; B01L2400/0406; B01L2400/08; B01L2400/084; B01L2400/086; B01L3/502746; Y; Y10; Y10S; Y10S435/00; Y10S435/81; Y10S436/00; Y10S436/804; Y10S436/805; Y10S436/807; Y10S436/809; Y10S436/81

Claims Analysis

Total Claims: 32
Claim 1
Independent Claim 145 words
An analytical device for determining the presence or an amount of an analyte in a test sample comprising, in combination: a base layer; an array of structures arising from said base layer, each of said structures having a surface providing immobilized reagent, said immobilized reagent covalently or non-covalently attached to said surface of said structure, said immobilized reagent capable of binding a member selected from the group consisting of analyte, analyte-analog, ancillary binding member, and labelled reagent; and a plurality of channels adjacent to said structures, wherein said test sample containing said analyte, analyte-analog, ancillary binding member, or labelled reagent flows through said channels, said analyte, analyte-analog, ancillary binding member, or labelled reagent diffusing across the width of said channels binding to said immobilized reagent, wherein the ratio of the height of said structures to the average width of said channels is greater than 2:1.
Claim 2
Dependent Claim 145 words
An analytical device for determining the presence or an amount of an analyte in a test sample comprising, in combination: a base layer; an array of structures arising from said base layer, each of said structures having a surface providing immobilized reagent, said immobilized reagent covalently or non-covalently attached to said surface of said structure, said immobilized reagent capable of binding a member selected from the group consisting of analyte, analyte-analog, ancillary binding member, and labelled reagent; and a plurality of channels adjacent to said structures, wherein said test sample containing said analyte, analyte-analog, ancillary binding member, or labelled reagent flows through said channels, said analyte, analyte-analog, ancillary binding member, or labelled reagent diffusing across the width of said channels binding to said immobilized reagent, wherein the ratio of the height of said structures to the average width of said channels is greater than 2:1.
Claim 3
Dependent Claim 19 words
The analytical device of claim 1 wherein said analyte and said immobilized reagent comprises an antigen and an antibody.
Claim 4
Dependent Claim 17 words
The analytical device of claim 1 wherein said analyte and said immobilized reagent comprises complementary nucleotide sequences.
Claim 5
Dependent Claim 19 words
The analytical device of claim 1 wherein said analyte and said immobilized reagent comprises a lectin and a carbohydrate.
Claim 6
Dependent Claim 19 words
The analytical device of claim 1 wherein said analyte and said immobilized reagent comprises an avidin and a biotin.
Claim 7
Dependent Claim 69 words
The analytical device of claim 1 wherein said structures are made with copolymers, blends, laminates, metallized foils, metallized films or metals deposited on a material selected from the group consisting of: polyolefins, polyesters, styrene containing polymers, polycarbonate, acrylic polymers, chlorine containing polymers, acetal homopolymers and copolymers, cellulosics and their esters, cellulose nitrate, fluorine containing polymers, polyamides, polyimides, polyetheretherketone, sulfur containing polymers, polyurethanes, silicon containing polymers, glass, and ceramic materials.
Claim 8
Dependent Claim 22 words
The analytical device of claim 1 wherein said structures can have a height ranging from about 1 micrometer to about 1 millimeter.
Claim 9
Dependent Claim 23 words
The analytical device of claim 1 wherein said structures can have an average width ranging from about 1 micrometer to about 1 millimeter.
Claim 10
Dependent Claim 21 words
The analytical device of claim 1 wherein said channel has a depth ranging from about 1 micrometer to about 1 millimeter.
Claim 11
Dependent Claim 22 words
The analytical device of claim 1 wherein said channel has an average width ranging from about 0.02 micrometers to about 20 micrometers.
Claim 12
Dependent Claim 17 words
The analytical device of claim 1 wherein said structures in said array of structures are similarly shaped.
Claim 13
Dependent Claim 28 words
The analytical device of claim 11 wherein said similarly shaped structures are selected from the group consisting of: diamonds, hexagons, octagons, rectangles, squares, circles, semi-circles, triangles and elipses.
Claim 14
Dependent Claim 21 words
The analytical device of claim 11 wherein said array of structures are staggered relative to the direction of test sample flow.
Claim 15
Dependent Claim 34 words
The analytical device of claim 1 further comprising a labelled reagent, said labelled reagent comprising a detectable label and a specific binding member which is specific for said analyte, analyte-analog, or ancillary binding member.
Claim 16
Dependent Claim 34 words
The analytical device of claim 1 wherein a detectable label is added to said analytical device, said detectable label is selected from the group consisting of: non-radioactive isotopes, metal chelators, and direct visual labels.
Claim 17
Dependent Claim 12 words
The analytical device of claim 1 wherein said device is a cuvette.
Claim 18
Dependent Claim 12 words
The analytical device of claim 1 wherein said device is a dipstick.
Claim 19
Dependent Claim 14 words
The analytical device of claim 1 further comprising a separator anterior to said structures.
Claim 20
Dependent Claim 15 words
The analytical device of claim 18 wherein said separator is a hydrophilic sintered porous matrix.
Claim 21
Dependent Claim 18 words
The analytical device of claim 19 wherein said matrix is treated with a red blood cell agglutinating agent.
Claim 22
Dependent Claim 13 words
The analytical device of claim 1 wherein said device has a control means.
Claim 23
Dependent Claim 24 words
The analytical device of claim 1 wherein said array of structures have multiple immobilized reagents to test for multiple analytes in said test sample.
Claim 24
Dependent Claim 19 words
The analytical device of claim 1 wherein differential pressure is used to drive said test sample through the device.
Claim 25
Dependent Claim 21 words
The analytical device of claim 1 wherein chambers are added to said device anterior or posterior to said array of structures.
Claim 26
Dependent Claim 15 words
The analytical device of claim 1 wherein said device has at least one alternate pathway.
Claim 27
Dependent Claim 20 words
The anaytical device of claim 25 wherein said alternate pathway transports said test sample to a separate array of structures.
Claim 28
Dependent Claim 23 words
The analytical device of claim 1 wherein said ancillary binding member binds to said analyte, and said analyte binds to said immobilized reagent.
Claim 29
Dependent Claim 45 words
The analytical device of claim 1 wherein said structures and channels of said devices are manufactured by at least one of the following steps: lasering, micromachining, photolithography, reactive ion etching, ion beam milling, embossing, electroforming, electroplating, injection molding, compression molding, casting, or reaction injection molding.
Claim 30
Dependent Claim 25 words
The analytical device of claim 28 wherein said direct visual labels are selected from the group consisting of fluorescent signals, chemiluminescent signals, and enzymatic signals.
Claim 31
Dependent Claim 193 words
An analytical device for determining the presence or an amount of an analyte in a test sample comprising, in combination: a base layer; an inlet port and a vent; an array of structures arising from said base layer, each of said structures having a surface providing a capture site for said analyte; an immobilized reagent, said immobilized reagent covalently or non-covalently attached to said surface of said structure, said immobilized reagent capable of binding an a member selected from the group comprising: analyte, analyte-analog, and an ancillary binding member; a plurality of channels adjacent to said structures, wherein said test sample containing said analyte, analyte-analog, or ancillary binding member flows through said channels, said analyte, analyte-analog, or ancillary binding member diffusing across the width of said channels to bind said immobilized reagent; and a labelled reagent comprising a specific binding member conjugated to a detectable label, said detectable label capable of producing a signal at said capture site, said signal indicating the presence or amount of said analyte present in said test sample, wherein the ratio of the height of said structures to the average width of said channels is greater than 2:1.
Claim 32
Dependent Claim 193 words
An analytical device for determining the presence or an amount of an analyte in a test sample comprising, in combination: a base layer; an inlet port and a vent; an array of structures arising from said base layer, each of said structures having a surface providing a capture site for said analyte; an immobilized reagent, said immobilized reagent covalently or non-covalently attached to said surface of said structure, said immobilized reagent capable of binding an a member selected from the group comprising: analyte, analyte-analog, and an ancillary binding member; a plurality of channels adjacent to said structures, wherein said test sample containing said analyte, analyte-analog, or ancillary binding member flows through said channels, said analyte, analyte-analog, or ancillary binding member diffusing across the width of said channels to bind said immobilized reagent; and a labelled reagent comprising a specific binding member conjugated to a detectable label, said detectable label capable of producing a signal at said capture site, said signal indicating the presence or amount of said analyte present in said test sample, wherein the ratio of the height of said structures to the average width of said channels is greater than 2:1.

References Cited (Backward Citations)

US4789628A Cited
WO1993022053A1 Cited
US5304487A Cited
US5498392A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-01-12 2001-07-14 2002-01-13 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-01-12 2005-07-14 2006-01-13 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-01-12 2009-07-14 2010-01-13 $7700.00 Window Closed / Lapsed

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