US2003040021A1PendingUtilityA1
Device and method for integrated diagnostics with multiple independent flow paths
Priority: Apr 18, 2000Filed: Apr 3, 2002Published: Feb 27, 2003
Est. expiryApr 18, 2020(expired)· nominal 20-yr term from priority
G01N 33/54388G01N 33/54366Y10T436/12Y10T436/11Y10T436/255
42
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Claims
Abstract
Devices and methods for performing assays to determine the presence or quantity of a specific analyte of interest in a fluid sample. In devices according to this invention two separate flow paths are established sequentially in the device with a single user activation step. The first flow path delivers the analyte of interest (if present in the sample) and conjugate soluble binding reagents to the solid phase. If analyte is present, an analyte:conjugate complex is formed and immobilized. The volume of sample delivered by this first path is determined by the absorbent capacity of the solid phase, and not by the amount of sample added to the device, relieving the user from the necessity of measuring the sample. The sample/conjugate mixture is prevented from entering the second flow path because the capillarity and the surface energy of the second flow path prevent it from being wetted by this mixture. The second flow path allows a wash reagent to remove unbound conjugate and sample from the solid phase to the absorbant, and optionally to deliver detection reagents. The invention may be adapted to many assay formats including, sandwich immunoassays, colloidal gold, or sol particle assays, heterogeneous generic capture assays and competitive assays. In one embodiment, sandwich assays can be performed by immobilizing an analyte binding reagent on the solid phase, and drying a labeled analyte binding reagent in the first flow path. In a competitive assay embodiment, the first flow path would contain labeled analyte that is dissolved by the sample, and the analyte binding reagent is immobilized on the solid phase. In each of these embodiments, the assay can be further modified to run in a “generic capture” format, where the solid phase binding reagent is instead conjugated to a generic ligand such as biotin, and dried in the first flow path (either together or separately from the other assay reagents), and a generic ligand binding reagent (such as avidin) is immobilized on the solid phase. Another aspect of the present invention includes a subassembly for the immunoassay device that is comprised of a plastic housing and a means for delivering fluid and/or wash solution. This subassembly comprises a structure formed from a hydrophobic polymer selectively treated with a water insoluble surface active agent that has been applied as a solution in an organic solvent rendering portions of the surface hydrophilic. When the surface is contacted with an aqueous liquid, it flows only along the treated areas, creating a defined fluid flow path, thereby delivering sample/conjugate solutions to said solid phase.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A device for performing an assay which determines the presence or quantity of an analyte in a fluid sample (1) using a solid phase capable of capturing said analyte or the analyte bound to a binding partner for the analyte, and (2) detecting the binding of said analyte or said analyte bound to its binding partner after washing unbound material from said solid phase, said device comprising:
(a) a first flow path for sample entry and delivery to a solid phase (d), which is independent of a second flow path defined by (b), a second fluid path material; (b) a second fluid path material essentially impermeable to said liquid sample but which defines a second flow path for said sample when made permeable by contact with a wash reagent (c); (c) a wash reagent permeable to said second fluid path material, which when released flows through said second fluid path material; (d) a solid phase zone permeable to said liquid sample, at the intersection between said first and second flow paths, whereby said liquid sample initially flows only along said first flow path and said solid phase zone into said solid phase but not into said second fluid path material until said second fluid path material is rendered hydrophilic by said wash reagent; (e) a means to test a single sample for a single analyte or a means to test a single sample for multiple analytes.
2 . Device of claim 1 wherein first flow path is through a capillary space called a sample delivery channel.
3 . Device of claim 1 wherein first flow path flows along a bibulous material.
4 . Device of claim 1 wherein first flow path is through a sample delivery channel containing dried conjugate soluble binding reagents.
5 . Device of claim 1 wherein binding partners for the assays can include antigens, antibodies, ligands, receptors, nucleic acid molecules, chemical reactants, fragments of these, and any other such reagent used in the art for conducting assays.
6 . Device of claim 1 wherein conjugate soluble binding reagents are dried in the sample delivery channel.
7 . Device of claim 1 wherein at least one of the conjugate soluble binding reagents is added to the sample prior to adding said sample to said device.
8 . Device of claim 1 wherein the assay involves an immobilized reactant or substrate on the solid phase, and detection occurs on said solid phase.
9 . Device of claim 1 wherein the assay involves having the reactant or substrate in said first flow path and detection occurs on said solid phase.
10 . Device of claim 1 wherein the solid phase is selected from the group consisting of: glass fiber mats, non-woven synthetic mats, sintered particulate structures, cast or extruded membrane materials, materials characterized by the presence of adhesion within the material, molded or cast open pore structure such as nylon or nitrocellulose, particulate material such as glass particles or polymer particles, or an electrochemical detector.
11 . Device of claim 1 wherein wash and/or substrate reagent(s), or wash/substrate reagent is delivered from a pierceable container(s) following activation of said device.
12 . Device of claim 1 wherein absorbent block is comprised of an absorbent material independent of second fluid path material.
13 . Device of claim 1 wherein second flow path may be through bibulous material or plastic.
14 . Device of claim 1 wherein the sample entry port may be located upstream of the solid phase or directly above the solid phase and sample may be applied via a cup structure or a sample absorbing tip.
15 . A device for performing an assay which determines the presence or quantity of an analyte in a fluid sample (1) using a solid phase capable of capturing said analyte or the analyte bound to a binding partner for the analyte, and (2) using at least one diffusibly immobilized capture reagent capable of binding said analyte or an analogue of said analyte, at least one substrate reagent or at least one combined wash/substrate reagent, and (3) detecting the binding of said analyte or said analogue of said analyte after washing unbound material from said solid phase, said device comprising:
(a) a sample entry port in fluid communication with a first flow path (b); (b) a first flow path in fluid communication with said sample entry port on a first end, having a solid phase containing at least one immobilized reagent therein, and a second fluid path material, on a second end, (c) a second fluid path material which is initially impermeable to said liquid sample, but which is made permeable to said sample when said second fluid path material is contacted with wash, or said combined wash/substrate reagent, or wash followed by substrate reagent; (d) a second flow path for said sample, independent of said first flow path, said second path having a first end and an excess reagent reservoir at second end, with said solid phase therein, said second flow path defined physically by the second fluid path material and fluidically by when said wash or said combined wash/substrate reagent renders said second fluid path material permeable to said sample, and said second flow path delivers wash and or said combined wash/substrate reagent to and through said solid phase, thereby removing unbound materials from said solid phase and delivering said wash or said wash/substrate reagent to said solid phase; (e) a means to test a single sample for a single analyte or a means to test a single sample for multiple analytes.
16 . Device of claim 15 wherein first flow path is a capillary space called a sample delivery channel.
17 . Device of claim 15 wherein first flow path moves along a bibulous material.
18 . Device of claim 15 wherein first flow path is a sample delivery channel containing dried reagents.
19 . Device of claim 15 wherein at least one of the conjugate soluble binding reagents is added to the sample prior to adding said sample to said device.
20 . Device of claim 15 wherein binding partners for the assays can include antigens, antibodies, ligands, receptors, nucleic acid molecules, chemical reactants, fragments of these, and any other reagent used in the art for conducting assays.
21 . Device of claim 15 wherein the sample entry port may be located upstream of the solid phase or directly above the solid phase and sample may be applied via a cup structure or a sample absorbing tip.
22 . Device of claim 15 wherein said wash reagent, wash/substrate reagent, or wash and substrate reagents are delivered from pierceable containers following activation of said device.
23 . Device of claim 15 wherein absorbent block comprises an absorbent material independent of second fluid path material.
24 . Device of claim 15 wherein second flow path may be bibulous material or plastic.
25 . A device of claim 15 wherein the solid phase material is selected from the group consisting of glass fiber mats, non-woven synthetic polymer mats, sintered particulate structures, cast or extruded membrane materials, or other materials characterized by the presence of adhesion within the material, or molded or cast open pore structure such as nylon or nitrocellulose, or particulate material sucha as glass particles or polymer particles, or an electrochemical detector.
26 . A device of claim 15 which includes said assay wherein detection occurs via immobilized reactant or substrate on solid phase, or via reactant or substrate present in first flow path that flows into said solid phase where detection occurs.
27 . A solid phase subassembly comprising a particulate solid phase material physically captured within a socklet which is permeable to sample and liquid reagents, but which does not allow the particulate solid phase material to exit said structure.
28 . A method for performing an assay which determines the presence or quantity of an analyte in a fluid sample (1) using a solid phase capable of capturing said analyte or analyte bound to a binding partner for the analyte, and (2) detecting the binding of said analyte or said analyte bound to its binding partner after washing unbound material from said solid phase, said method comprising:
(a) contacting a liquid sample with a first flow path, (in the sample delivery channel) said path in fluid communication with a sample entry port on a first end, a solid phase containing at least one immobilized reagent therein, said solid phase within said first flow path, and a second fluid path material, on a second end, said second fluid path material in communication with said solid phase; (b) flowing said liquid sample initially through said first flow path to said second fluid path material which is initially impermeable to said liquid sample, but which is made permeable to said sample when said second fluid path material is contacted with wash reagent, substrate reagent or combined wash/substrate reagent, said second fluid path material to define a second flow path for said sample, independent of said first flow path, said second flow path having a first end and an excess reagent reservoir at a second end, with said solid phase therein, which second flow path delivers said wash reagent, or wash and substrate reagents, or combined wash/substrate reagent to and through said solid phase, thereby removing unbound materials from said solid phase, and delivering wash or wash/substrate reagent to said solid phase; (c) determining the presence or amount of analyte using the analyte detection reagent.
29 . Method of claim 28 wherein said binding partners for the assays can include antigens, antibodies, ligands, receptors, nucleic acid molecules, chemical reactants, fragments of these, and any other reagent used in the art for conducting assays.
30 . An assay method for the determination of a analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample containing the analyte with: (i) a first immunological binding partner to the analyte, wherein the first immunological binding partner contains a detectable label, and (ii) a second immunological binding partner of the analyte wherein the second immunological binding partner has been modified by the covalent attachment of a receptor molecule; (b) allowing the first and second immunological binding partner to form an immune complex with the analyte; (c) contacting the mixture in (a) with a liquid permeable solid phase material comprising a binding partner for said receptor which receptor has been covalently attached to said second immunological binding partner, and which said binding partner is non-diffusively bound to said solid phase, said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a flow path; (d) allowing the receptor molecule attached to the second immunological binding partner to form a complex with the receptor-binding partner non-diffusively bound to the solid phase material; (e) flowing a liquid reagent permeable to said second fluid path material along a second flow path, within said second fluid path material, such that said liquid reagent removes unbound reactants from said solid phase; (f) detecting the label attached to the first immunological binding partner as part of the immune complex formed in (b).
31 . Method of claim 30 wherein the binding partners can include antigens, antibodies, ligands, receptors, nucleic acid molecules, chemical reactants, fragments of these, and other such reagents used in the art for conducting assays.
32 . Method of claim 30 wherein the detecting step (f) is by a flowing a substrate reagent through said second flow path in said second fluid path material.
33 . Method of claim 30 wherein said substrate reagent is a substrate for an enzyme.
34 . Method of claim 30 wherein said reagent permeable to said second fluid path material is an aqueous solution containing a surface active agent.
35 . Method of claim 30 wherein said surface active agent is a surfactant, alcohol, or any other miscible organic solvent.
36 . Method of claim 30 wherein said second fluid path material is a bibulous material.
37 . Method of claim 36 wherein said bibulous material is a non-woven polyester fiber material.
38 . Method of claim 30 wherein said first or second immunological binding partner to said analyte is added to the sample prior to initiation of said assay.
39 . Method of claim 30 wherein said second fluid path material is plastic.
40 . Method of claim 39 wherein said second fluid path material is a structure formed from a hydrophobic polymer.
41 . Method of claim 30 wherein said solid phase is a formed (molded or cast) in an open pore structure.
42 . Method of claim 41 wherein said open pore structure is nylon or nitrocellulose.
43 . Method of claim 30 wherein said solid phase is an electrochemical detector.
44 . Method of claim 41 wherein said solid phase is a particulate material.
45 . Method of claim 44 wherein said solid phase is glass particles.
46 . Method of claim 44 wherein said solid phase is polymer particles.
47 . Method of claim 30 wherein said detectable label of conjugate binding reagent is a light absorbing particle.
48 . Method of claim 47 wherein said light absorbing particle is colloidal gold.
49 . Method of claim 47 wherein said light absorbing particle is a colored latex particle.
50 . Method of claim 47 wherein said detectable label is a phosphorescent molecule.
51 . Method of claim 30 wherein said detectable label is a fluorescent molecule.
52 . Method of claim 30 wherein said detectable label is an enzyme.
53 . Method of claim 52 wherein said enzyme is horseradish peroxidase.
54 . Method of claim 30 wherein said receptor molecule covalently attached to said second conjugate binding partner is biotin.
55 . Method of claim 54 wherein said receptor-binding partner non-diffusively bound to said solid phase is avidin.
56 . Device of claim 44 or 45 wherein said solid phase material is selected from the group consisting of inorganic or organic particulates, glass beads, or polymer particles.
57 . Method of claim 30 wherein detection occurs via immobilized reactant or substrate on said solid phase, or via reactant or substrate present in first flow path into said solid phase where detection occurs.
58 . An assay method for the determination of an analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample containing the analyte with: (i) a first conjugate binding partner to the analyte, wherein the first conjugate binding partner contains a detectable label, (ii) a second conjugate binding partner of the analyte wherein the second conjugate binding partner has been modified by the covalent attachment of a receptor molecule, and (iii) a solid phase material wherein a binding partner of the receptor molecule attached to the second conjugate binding partner has been non-diffusively bound to the solid phase material, (b) simultaneously allowing the first and second conjugate binding partners to form an immune complex with the analyte, and the receptor molecule attached to the second conjugate soluble binding partner and the receptor-binding partner non-diffusively bound to the solid phase to form an immobilization complex, wherein said solid phase is in contact with a second fluid path material initially impermeable to said mixture, and which defines a first flow path; (c) flowing a wash reagent, or wash/substrate reagent containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (d) detecting the label attached to the first conjugate binding partner as part of the immune and immobilization complexes formed in (b).
59 . Method of claim 58 wherein the detecting step (d) is by flowing a substrate reagent through said second flow path in said second fluid path material.
60 . Method of claim 59 wherein said substrate reagent is a substrate for an enzyme.
61 . Method of claim 58 wherein said reagent permeable to said second fluid path material is a wash solution containing a surface active agent.
62 . Method of claim 58 wherein said surface active agent is a surfactant, alcohol, or any other miscible organic solvent.
63 . Method of claim 58 wherein said second fluid path material is a bibulous material.
64 . Method of claim 63 wherein said bibulous material is a non-woven polyester fiber material.
65 . Method of claim 58 wherein said second fluid path material is plastic.
66 . Method of claim 58 wherein said second fluid path material is a structure formed from a hydrophobic polymer.
67 . Method of claim 58 wherein said solid phase is a formed (molded or cast) open pore structure.
68 . Method of claim 67 wherein said open pore structure is nylon.
69 . Method of claim 67 wherein said open pore structure is nitrocellulose.
70 . Method of claim 58 wherein said solid phase is a particulate material.
71 . Method of claim 58 wherein said solid phase is glass particles.
72 . Method of claim 58 wherein said solid phase is polymer particles.
73 . Method of claim 58 wherein said detectable label is a light absorbing particle.
74 . Method of claim 73 wherein said light absorbing particle is colloidal gold.
75 . Method of claim 73 wherein said light absorbing particle is a colored latex particle.
76 . Method of claim 58 wherein said detectable label is a phosphorescent molecule.
77 . Method of claim 58 wherein said detectable label is a fluorescent molecule.
78 . Method of claim 58 wherein said detectable label is an enzyme.
79 . Method of claim 78 wherein said enzyme is horseradish peroxidase.
80 . Method of claim 58 wherein said receptor molecule covalently attached to said second conjugate binding partner is biotin.
81 . Method of claim 80 wherein said receptor-binding partner non-diffusively bound to said solid phase is avidin.
82 . Method of claim 58 wherein detection occurs via immobilized reactant or substrate on said solid phase, or via reactant or substrate present in first flow that flows into said solid phase where detection occurs.
83 . Method of claim 58 wherein said first conjugate binding partner is in the sample delivery channel.
84 . Method of claim 58 wherein said first conjugate soluble binding partner is added to said sample before adding to device.
85 . Method of claim 58 wherein said solid phase is an electrochemical detector.
86 . An assay method for the determination of an analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample containing said analyte with: (i) a first immunological binding partner to said analyte, wherein the first immunological binding partner contains a detectable label, and (ii) a second immunological binding partner of said analyte which is nondiffusively immobilized on a solid phase; (b) allowing the first and second immunological binding partner to form an immune complex with said analyte, wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (c) flowing a wash reagent, or wash/substrate reagent containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (d) detecting the label attached to the first conjugate binding partner as part of the immune complex formed in (b).
87 . Method of claim 86 wherein the detecting step (d) is by a flowing a substrate reagent through said second flow path in said second fluid path material.
88 . Method of claim 86 wherein said reagent permeable to said second fluid path material is a wash solution containing a surface active agent.
89 . Method of claim 86 wherein said surface active agent is a surfactant, alcohol, or any other miscible organic solvent.
90 . Method of claim 86 wherein said second fluid path material is a bibulous material.
91 . Method of claim 90 wherein said bibulous material is a non-woven polyester fiber material.
92 . Method of claim 86 wherein said second fluid path material is plastic.
93 . Method of claim 86 wherein said second fluid path material is a structure formed from a hydrophobic polymer.
94 . Method of claim 86 wherein said solid phase is a formed (molded or cast) open pore structure.
95 . Method of claim 94 wherein said open pore structure is nylon.
96 . Method of claim 95 wherein said open pore structure is nitrocellulose.
97 . Method of claim 86 wherein said solid phase is a particulate material.
98 . Method of claim 97 wherein said solid phase is glass particles.
99 . Method of claim 97 wherein said solid phase is polymer particles.
100 . Method of claim 86 wherein said detectable label is a light absorbing particle.
101 . Method of claim 100 wherein said light absorbing particle is colloidal gold.
102 . Method of claim 100 wherein said light absorbing particle is a colored latex particle.
103 . Method of claim 86 wherein said detectable label is a phosphorescent molecule.
104 . Method of claim 86 wherein said detectable label is a fluorescent molecule.
105 . Method of claim 86 wherein said detectable label is an enzyme.
106 . Method of claim 105 wherein said enzyme is horseradish peroxidase.
107 . Method of claim 86 wherein said receptor molecule covalently attached to said second conjugate binding partner is biotin.
108 . Method of claim 107 wherein said receptor-binding partner non-diffusively bound to said solid phase is avidin.
109 . Method of claim 86 wherein detection occurs via immobilized reactant or substrate on said solid phase, or via reactant or substrate present in first flow path that flows into said solid phase where detection occurs.
110 . Method of claim 86 wherein said first immunological binding partner is in the sample delivery channel.
111 . Method of claim 86 wherein said first immunological binding partner is added to the sample before adding said sample to the device.
112 . Method of claim 86 wherein said solid phase is an electrochemical detector.
113 . An assay method for the determination of an analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample and a first immunologcal binding partner to said analyte, wherein said first immunological binding partner contains a detectable label; (b) allowing said first conjugate soluble binding partner to form a complex with said analyte; (c) contacting said complex with a second immunological binding partner for said analyte which is non-diffusively immobilized on a solid phase wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (d) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the said wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (e) detecting the label attached to the first conjugate binding partner as part of the immune complex formed in (b).
114 . Method of claim 113 wherein the detecting step (e) is by flowing a substrate reagent through said second flow path in said second fluid path material.
115 . Method of claim 114 wherein said substrate reagent is a substrate for an enzyme.
116 . Method of claim 113 wherein said reagent permeable to said second fluid path material is a wash solution containing a surface active agent.
117 . Method of claim 116 wherein said surface active agent is a surfactant, alcohol, or any other miscible organic solvent.
118 . Method of claim 113 wherein said second fluid path material is a bibulous material.
119 . Method of claim 118 wherein said bibulous material is a non-woven polyester fiber material.
120 . Method of claim 113 wherein said second fluid path material is plastic.
121 . Method of claim 113 wherein said second fluid path material is a structure formed from a hydrophobic polymer.
122 . Method of claim 113 wherein said solid phase is a formed (molded or cast) open pore structure.
123 . Method of claim 122 wherein said open pore structure is nylon.
124 . Method of claim 122 wherein said open pore structure is nitrocellulose.
125 . Method of claim 113 wherein said solid phase is a particulate material.
126 . Method of claim 125 wherein said solid phase is glass particles.
127 . Method of claim 125 wherein said solid phase is polymer particles.
128 . Method of claim 113 wherein said detectable label is a light absorbing particle.
129 . Method of claim 128 wherein said light absorbing particle is colloidal gold.
130 . Method of claim 128 wherein said light absorbing particle is a colored latex particle.
131 . Method of claim 113 wherein said detectable label is a phosphorescent molecule.
132 . Method of claim 113 wherein said detectable label is a fluorescent molecule.
133 . Method of claim 113 wherein said detectable label is an enzyme.
134 . Method of claim 113 wherein said enzyme is horseradish peroxidase.
135 . Method of claim 113 wherein said receptor molecule covalently attached to said second conjugate binding partner is biotin.
136 . Method of claim 135 wherein said receptor-binding partner non-diffusively bound to said solid phase is avidin.
137 . Method of claim 113 wherein detection occurs via immobilized reactant or substrate on said solid phase, or via reactant or substrate present in first flow path that flows into said solid phase where detection occurs.
138 . Method of claim 113 wherein first immunological binding partner is in the sample delivery channel.
139 . Method of claim 113 wherein said first immunological binding partner is added to sample before adding it to device.
140 . Method of claim 113 wherein said solid phase is an electrochemical detector.
141 . An assay method for the determination of an analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample containing the substance with: (i) a first conjugate soluble binding partner to the substance, wherein the first conjugate soluble binding partner contains a detectable label, (ii) a second conjugate soluble binding partner of the substance wherein the second soluble conjugate binding partner has been modified by the covalent attachment of a receptor molecule, and (iii) a solid phase material wherein a binding partner of the receptor molecule attached to the second conjugate soluble binding partner has been non-diffusively bound to the solid phase material; (b) simultaneously allowing the first and second conjugate soluble binding partners to form an immune complex with said analyte, and the receptor molecule attached to the second conjugate soluble binding partner and the receptor-binding partner non-diffusively bound to the solid phase to form an immobilized complex, wherein said solid phase is in contact with a second fluid path material initially impermeable to said mixture, and which defines a first flow path; (c) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (d) detecting the label attached to the first conjugate binding partner as part of the immune and immobilized complexes formed in (b).
142 . Method of claim 141 wherein the detecting step (d) is by a flowing a substrate reagent through said second flow path in said second fluid path material.
143 . Method of claim 142 wherein said substrate reagent is a substrate for an enzyme.
144 . Method of claim 141 wherein said reagent permeable to said second fluid path material is a wash solution containing a surface active agent.
145 . Method of claim 141 wherein said surface active agent is a surfactant, alcohol, or any other miscible organic solvent.
146 . Method of claim 141 wherein said second fluid path material is a bibulous material.
147 . Method of claim 146 wherein said bibulous material is a non-woven polyester fiber material.
148 . Method of claim 141 wherein said second fluid path material is plastic.
149 . Method of claim 141 wherein said second fluid path material is a structure formed from a hydrophobic polymer.
150 . Method of claim 141 wherein said solid phase is a formed (molded or cast) open pore structure.
151 . Method of claim 150 wherein said open pore structure is nylon.
152 . Method of claim 150 wherein said open pore structure is nitrocellulose.
153 . Method of claim 141 wherein said solid phase is a particulate material.
154 . Method of claim 153 wherein said solid phase is glass particles.
155 . Method of claim 153 wherein said solid phase is polymer particles.
156 . Method of claim 141 wherein said detectable label is a light absorbing particle.
157 . Method of claim 156 wherein said light absorbing particle is colloidal gold.
158 . Method of claim 156 wherein said light absorbing particle is a colored latex particle.
159 . Method of claim 141 wherein said detectable label is a phosphorescent molecule.
160 . Method of claim 141 wherein said detectable label is a fluorescent molecule.
161 . Method of claim 141 wherein said detectable label is an enzyme.
162 . Method of claim 161 wherein said enzyme is horseradish peroxidase.
163 . Method of claim 141 wherein said receptor molecule covalently attached to said second conjugate binding partner is biotin.
164 . Method of claim 163 wherein said receptor-binding partner non-diffusively bound to said solid phase is avidin.
165 . Method of claim 141 wherein detection occurs immobilized reactant or substrate on said solid phase, or via reactant or substrate present in first flow path that flows into said solid phase where detection occurs.
166 . Method of claim 141 wherein said first conjugate soluble binding reagent is added to sample delivery channel.
167 . Method of claim 141 wherein said first conjugate soluble binding reagent is added to said sample before adding it to the device.
168 . Method of claim 141 wherein said solid phase is an electrochemical detector.
169 . An assay method for the determination of a analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample and a first binding partner to the analyte, wherein said first binding partner contains a detectable label; (b) allowing said first conjugate soluble binding partner to form a complex with said analyte; (c) contacting said complex with the analyte or an analog of the analyte which is nondiffusively immobilized on a solid phase wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (d) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the said wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (e) detecting the label attached to the solid phase, and relating inhibition of the amount of label to the concentration of the analyte.
170 . An assay method for the determination of a analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample and a first binding partner to the analyte, wherein said first binding partner contains a detectable label, and a second reagent comprising the analyte or an analyte analog covalently coupled to a receptor molecule; (b) allowing said first conjugate soluble binding partner to form complexes with said analyte and said analyte/analyte analog/receptor conjugate; (c) contacting said mixture with a binding partner of the receptor molecule which is nondiffusively immobilized on a solid phase wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (d) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the said wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (e) detecting the label attached to the solid phase, and relating inhibition of the amount of label to the concentration of the analyte.
171 . An assay method for the determination of a analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample and a conjugate of the analyte or an analog of the analyte bound to a detectable label; (b) allowing said first conjugate soluble binding partner to form a complex with said analyte; (c) contacting said mixture with a binding partner of the analyte which is nondiffusively immobilized on a solid phase wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (d) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the said wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (e) detecting the label attached to the solid phase, and relating inhibition of the amount of label to the concentration of the analyte.
172 . An assay method for the determination of a analyte in a liquid sample comprising the steps of:
(a) forming a mixture of a sample and a conjugate of the analyte or an analog of the analyte bound to a detectable label, and a second reagent comprising a soluble binding partner to the analyte covalently coupled to a receptor molecule; (b) allowing said soluble binding partner of the analyte to form complexes with said analyte and with said analyte/analyte analog/receptor conjugate; (c) contacting said mixture with a binding partner of the receptor molecule which is nondiffusively immobilized on a solid phase wherein said solid phase in contact with a second fluid path material initially impermeable to said sample, and which defines a first flow path; (d) flowing a wash solution containing a surface active agent along a second flow path, within said second fluid path material, such that the surface active agent allows the said wash reagent to flow through said second flow path, thereby removing unbound reactants from said solid phase; (e) detecting the label attached to the solid phase, and relating inhibition of the amount of label to the concentration of the analyte.Join the waitlist — get patent alerts
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