EP0264036A2
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EP
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Analytical device and method for detecting chlamydia trachomatis and neisseria gonorrhoeae
Assignee: Abbott Laboratories
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Filing: 1987-10-02
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Granted: —
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Expires: 2007-10-02
Abstract
Abstract A method and device useful in solid-phase binding assay to determine the presence of a Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a test sample. The device comprises a porous matrix of fibers and a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from about 0.1 to 10 microns. The particles are retained and immobilized upon the fibers of the matrix. The method comprises contacting a test sample with a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from 0.1 to about 10 microns and detecting the amount of antigen bound to the particles.
Inventors
- 👤 Vincent Andrew Varitek, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-25 03:52
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/569; G01N33/571; G01N33/543; G01N33/54366; G01N33/56911; G01N33/56927
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
128 words
A solid-phase assay device useful in a binding assay to determine the presence of Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a sample, the device comprises a substantially planar layer of a material having a porous matrix of fibers and plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers, the substantially planar layer having a first, sample-contacting surface and a second surface opposed to the first surface, and being disposed in the device such that, when the device is in use the performance of the assay, at least a portion of the sample contacting the first surface passes through the substantially planar layer to the second surface.
Claim 2
Dependent Claim
128 words
A solid-phase assay device useful in a binding assay to determine the presence of Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a sample, the device comprises a substantially planar layer of a material having a porous matrix of fibers and plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers, the substantially planar layer having a first, sample-contacting surface and a second surface opposed to the first surface, and being disposed in the device such that, when the device is in use the performance of the assay, at least a portion of the sample contacting the first surface passes through the substantially planar layer to the second surface.
Claim 3
Dependent Claim
40 words
The assay device of Claim 1, wherein the device additionally comprises filtering means disposed in relationship to the first surface of the substantially planar layer, such that sample fluid passes through said filtering means prior to contacting the first surface.
Claim 4
Dependent Claim
46 words
The assay device of Claim 1, wherein the device additionally comprises absorbent means disposed in relationship to the lower surface of the substantially planar layer, such that at least a portion of the fluid passing through the substantially planar layer is absorbed by the absorbent means.
Claim 5
Dependent Claim
44 words
The assay device of Claim 3, wherein the device additionally comprises a barrier layer interposed between the substantially planar layer and the absorbent means, the barrier layer being adapted, to restrict fluid retained by the absorbent means from returning to the substantially planar layer.
Claim 6
Dependent Claim
96 words
The assay device of Claim 1, wherein said substantial planar layer further comprises a reaction surface having a negative control area, a positive control area and an anlyte binding area configured so that the positive control area interacts with the analyte binding area to form a first representational symbol having a first meaning upon the occurrence of a positive test result in the use of the device and to form a second representational symbol different from that of the first representational symbol upon the occurrence of a negative test result in the use of the device.
Claim 7
Dependent Claim
95 words
The assay device of Claim 5, wherein the positive control area is formed on the reaction surface in the shape of a rectangular bar and wherein the analyte binding area is formed on the reaction surface in the shape of two rectangular bars on opposite sides of the oriented perpendicularly to the positive control area, whereby the analyte binding area taken together with the positive control area from the shape of a "+" sign and where the positive control area acts alone to form a "-" symbol upon the occurrence of a negative test result.
Claim 8
Dependent Claim
16 words
The assay device of Claim 1 wherein said spherical, solid particles are a homopolymer of polytetrafluoroethylene.
Claim 9
Independent Claim
170 words
A method for performing a binding assay to determine the presence of Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a test sample, comprising the steps of: a) contacting a porous matrix of fibers and a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers, whereby antigen in the sample becomes bound to the particles forming an antigen complex on the partilcs; b) contacting the antigen complex on the particles with a second substance capable of reaction with the antigen, which is labeled with a substance capable of producing a detectable response in the presence of the antigen and an indicator substance, whereby the labeled substance becomes bound to the complex on the particles; c) removing unbound labeled substance from the material; d) contacting the complex with the indicator substance; and e) detecting the response produced as a function of the presence or amount of the antigen in the sample.
Claim 10
Independent Claim
170 words
A method for performing a binding assay to determine the presence of Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a test sample, comprising the steps of: a) contacting a porous matrix of fibers and a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from 0.1 to 10 microns, the particles being retained and immobilized within said matrix upon the fibers, whereby antigen in the sample becomes bound to the particles forming an antigen complex on the partilcs; b) contacting the antigen complex on the particles with a second substance capable of reaction with the antigen, which is labeled with a substance capable of producing a detectable response in the presence of the antigen and an indicator substance, whereby the labeled substance becomes bound to the complex on the particles; c) removing unbound labeled substance from the material; d) contacting the complex with the indicator substance; and e) detecting the response produced as a function of the presence or amount of the antigen in the sample.
Claim 11
Dependent Claim
42 words
The method of Claim 8, wherein the detectable response is a visually detectable "+" sign when detectable amounts of antigen are present in the sample, and a visually detectable "-" sign when detectable amounts of antigen are not present in the sample.
Claim 12
Independent Claim
114 words
A method for producing a material useful for determining the presence of a Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a fluid, comprising the steps of: a) incubating with a sample of the fluid a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from about 0.1 to about 10 microns, whereby the antigen becomes bound to the particles forming an antigen complex on the particles; and b) contacting a porous, fibrous matrix with the incubated particles, whereby at least a portion of the particles become retained and immobilized within the matrix upon at least a portion of the fibers. c) detecting the presence of antigen bound to the particles.
Claim 13
Independent Claim
114 words
A method for producing a material useful for determining the presence of a Chlamydia trachomatis or Neisseria gonorrhoeae antigen in a fluid, comprising the steps of: a) incubating with a sample of the fluid a plurality of substantially spherical, solid particles comprising polytetrafluoroethylene having an average diameter of from about 0.1 to about 10 microns, whereby the antigen becomes bound to the particles forming an antigen complex on the particles; and b) contacting a porous, fibrous matrix with the incubated particles, whereby at least a portion of the particles become retained and immobilized within the matrix upon at least a portion of the fibers. c) detecting the presence of antigen bound to the particles.
References Cited (Backward Citations)
No citation records indexed.
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