EP0217403B1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Solid-phase analytical device and method for using same
Assignee: Alere Switzerland GmbH
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Filing: 1986-10-03
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Granted: 1992-07-22
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Expires: 2006-10-03
Abstract
Abstract A novel material and device useful in solid-phase binding assays to determine the presence or amount of an analyte in a test sample, particularly antigens or antibodies, is disclosed. The material comprises a porous matrix of fibers and a plurality of substantially spherical, solid particles having an average diameter of from about 0.1 to about 5 microns. The particles are retained and immobilized upon the fibers of the matrix. Preferably, the particles have on their surfaces a substance capable of reaction with the analyte in the sample, and the average diameter of the particles is less than the average pore size of the matrix. The device, in a preferred embodiment, comprises a substantially planar layer of the described material.
Inventors
- 👤 William E. Brown Iii
- 👤 Sharon M. Devereaux
- 👤 Kevin M. Knigge
- 👤 John M. Clemens
- 👤 John G. Hofler
- 👤 Sarah E. Safford
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-06 08:18
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/569; G01N33/56911; G01N33/52; G01N33/521; G01N33/523; G01N33/528; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54391; G01N33/576; G01N33/5761; G01N33/5764; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97; Y10S435/971
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
81 words
A material (12) useful in binding assay to determine the presence or amount of an analyte in a test sample, which material comprises a porous matrix of fibers and a plurality of substantially spherical solid particles having an average diameter of from 0.1 to 5 micrometres, characterized in that said particles are retained and immobilized within said matrix upon the fibers thereof, and in that the average diameter of said particles is less than the average pore size of said matrix.
Claim 2
Dependent Claim
25 words
A material according to claim 1, characterized in that said particles have on their surfaces a substance capable of binding an analyte in the sample.
Claim 3
Dependent Claim
148 words
A solid-phase assay device useful in a binding assay to determine the presence or amount of an analyte in a fluid sample, said device comprising: a carrier means (14), a substantially planar layer of material (12) defining a first sample-contacting surface (12a) and a second surface (12b) opposed to said first surface and being disposed in said carrier means (14) such that, when the device is in use in the performance of an assay, at least a portion of the fluid sample contacting the first surface (12a) passes through said material (12) to the second surface (12b), characterized in that said material (12) is constituted by a material as defined in claim 1 or 2, and in that at least some of said analyte of said fluid sample is held on the surface of the particles immobilized within said matrix of said material (12) on the fibres thereof.
Claim 4
Dependent Claim
50 words
An assay device according to claim 3, characterized in that it further comprises filtering means (22) disposed in relationship to the first surface (12a) of said substantially planar layer of material (12), such that sample fluid can pass through said filtering means (22) prior to contacting the first surface (12a).
Claim 5
Dependent Claim
55 words
An assay device according to claim 3 or 4, characterized in that it further comprises absorbent means (20) disposed in relationship to said second surface (12b) of said substantially planar layer of material (12), such that at least a fraction of fluid sample passing through said material (12) is absorbed by said absorbent means (20).
Claim 6
Dependent Claim
60 words
An assay device according to claim 3 or 4 and 5, characterized in that it comprises a barrier layer (18) interposed between said substantially planar layer of material (12) and said absorbent means (20), wherein said barrier layer (18) is constructed to restrict fluid retained by said absorbent means (20) from returning to said substantially planar layer of material (12).
Claim 7
Dependent Claim
19 words
An assay device according to claim 6, characterized in that said barrier layer (18) comprises a polyethylene weave material.
Claim 8
Dependent Claim
213 words
A binding assay method to determine the presence or amount of an analyte in a test sample, comprising the steps of: a) providing a material (12) comprising a porous matrix of fibers and a plurality of substantially spherical solid particles having an average diameter of from 0.1 to 5 micrometres, b) contacting a material (12) with the sample, whereby analyte in the sample becomes bound to a substance on the particles which is capable of binding the analyte, thereby to form a substance/analyte complex on said particles; c) contacting the material (12) containing the complex on the particles with a second substance capable of binding the analyte, which is labeled with a substance capable of producing a detectable response in the presence of the analyte and an indicator substance, whereby the labeled substance becomes bound to the complex on the particles; d) removing unbound labeled substance from the material; e) contacting the material with the indicator substance; and f) detecting the response produced as a function of the presence or amount of the analyte in the sample, characterized in that said particles have an average diameter which is less than the average pore size of said matrix, and in that said particles are retained and immobilized within said matrix upon the fibers thereof.
Claim 9
Dependent Claim
61 words
An assay method according to claim 8, characterized in that the particles are retained and immobilized within said matrix such that the detectable response forms a visually detectable plus sign (32 and 34) when detectable amounts of analyte are present in the sample, and a visually detectable minus sign (32) when detectable amounts of analyte are not present in the sample.
Claim 10
Dependent Claim
16 words
An assay method according to claim 8, wherein the analyte is beta-hCG, Strep-A antigen or HBsAg.
Claim 11
Independent Claim
134 words
A method for producing a material useful for determining the presence or amount of an analyte in a fluid, comprising the steps of incubating a plurality of substantially spherical, solid particles having an average diameter of from 0.1 to 5 micrometres, with a substance capable of binding an analyte, whereby the substance capable of binding the analyte becomes bound to the particles to form a binding substance/particle complex, characterized in that it further comprises the step of contacting a porous, fibrous matrix with the incubated particle complex to form a material (12) wherein the average diameter of said particles is less than the average pore size of said matrix and whereby at least a portion of the particles become retained and immobilized within the matrix upon at least a portion of the fibers thereof.
Claim 12
Dependent Claim
115 words
A solid-phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample, comprising a material as defined in claim 1, defining a reaction surface having a first control area (30) for displaying a detectable response if the assay results are invalid, a second control area (32) for displaying a detectable response indicative of a valid assay result, and an analyte binding area (34) for displaying a detectable result indicative of the presence or amount of the analyte in the fluid sample, characterized in that the second control area (32) and the analyte binding area (34) are oriented near one another in the reaction area.
Claim 13
Dependent Claim
88 words
A solid-phase assay device according to claim 12, characterized in that the first control area (30) comprises a negative control area (30) and the second control area (32) comprises a positive control area (32), wherein the areas (30, 32, 34) are oriented in only one reaction area so that each of the negative control area (30), the positive control area (32) and the analyte binding area (34) is capable of being simultaneously contacted by singly applied drops of the fluid sample and by reagents used in the assay.
Claim 14
Dependent Claim
32 words
A solid phase assay device according to claim 12 or 13, characterized in that the second control area (32) is formed on the reaction surface in the shape of a minus sign.
Claim 15
Dependent Claim
51 words
A solid phase assay device according to claim 12, 13 or 14, characterized in that the analyte binding area (34) is formed on the reaction surface in a manner such that the analyte binding area (34) taken together with the second control area (32) form the shape of a plus sign.
Claim 16
Dependent Claim
36 words
A solid phase assay device according to claim 12 or 13, characterized in that at least one of the second control area (32) and the analyte binding area (34) is formed in the shape of dot.
Claim 17
Dependent Claim
34 words
A solid phase assay device according to claim 12, 13, 14, 15 or 16, characterized in that the first control area (30) surrounds the second control area (32) and the analyte binding area (34).
Claim 18
Dependent Claim
79 words
A solid-phase assay device according to claim 12, 13, 14, 15, 16 or 17, characterized in that it further comprises a fluid chamber (17) for receiving the fluid sample and reagents used in the performance of the assay, said fluid chamber (17) being defined by at least one sidewall (16a) and base wall (12a), said base wall (12a) comprising the reaction surface having the first control area (30), the second control area (32) and the analyte binding area (34).
Claim 19
Dependent Claim
103 words
A method of manufacturing a material (12) as defined in claim 1, useful in a binding assay to determine the presence or amount of an analyte in a test sample, comprising the step of; providing a porous matrix of fibers and a plurality of substantially spherical solid particles having an average diameter of from 0.1 to 5 micrometres, characterized in that it comprises the further step of retaining and immobilizing said particles within said matrix upon the fibers thereof, and the intermediate step of selecting said particles to have an average diameter which is less than the average pore size of said matrix.
Claim 20
Dependent Claim
29 words
A method of manufacturing a material according to claim 1, characterized in that said particles have on their surfaces a substance capable of binding an analyte in the sample.
Claim 21
Dependent Claim
118 words
A solid-phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample, comprising a material manufactured by the method defined in claim 19, defining a reaction surface having a first control area (30) for displaying a detectable response if the assay results are invalid, a second control area (32) for displaying a detectable response indicative of a valid assay result, and an analyte binding area (34) for displaying a detectable result indicating of the presence or amount of the analyte in the fluid sample, characterized in that the second control area (32) and the analyte binding area (34) are oriented near one another in the reaction area.
Claim 22
Dependent Claim
88 words
A solid-phase assay device according to claim 21, characterized in that the first control area (30) comprises a negative control area (30) and the second control area (32) comprises a positive control area (32), wherein the areas (30, 32, 34) are oriented in only one reaction area so that each of the negative control area (30), the positive control area (32) and the analyte binding area (34) is capable of being simultaneously contacted by singly applied drops of the fluid sample and by reagents used in the assay.
Claim 23
Dependent Claim
32 words
A solid phase assay device according to claim 21 or 22, characterized in that the second control area (32) is formed on the reaction surface in the shape of a minus sign.
Claim 24
Dependent Claim
51 words
A solid phase assay device according to claim 21, 22 or 23, characterized in that the analyte binding area (34) is formed on the reaction surface in a manner such that the analyte binding area (34) taken together with the second control area (32) form the shape of a plus sign.
Claim 25
Dependent Claim
37 words
A solid phase assay device according to claim 21 or 22, characterized in that at least one of the second control area (32) and the analyte binding area (34) is formed in the shape of a dot.
Claim 26
Dependent Claim
34 words
A solid phase assay device according to claim 21, 22, 23, 24 or 25, characterized in that the first control area (30) surrounds the second control area (32) and the analyte binding area (34).
Claim 27
Dependent Claim
79 words
A solid-phase assay device according to claim 21, 22, 23, 24, 25 or 26, characterized in that it further comprises a fluid chamber (17) for receiving the fluid sample and reagents used in the performance of the assay, said fluid chamber (17) being defined by at least one sidewall (16a) and base wall (12a), said base wall (12a) comprising the reaction surface having the first control area (30), the second control area (32) and the analyte binding area (34).
References Cited (Backward Citations)
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