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EP0376135A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Improved dipstick device for assays

Assignee: WR Grace and Co Conn
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Filing: 1989-12-20
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Granted: —
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Expires: 2009-12-20
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Abstract

Abstract A dipstick is disclosed which can be used in assays to determine the presence or absence of a target analyte in a viscous liquid or a liquid which comprises cellular or particulate matter. The dipstick is a thermoplastic support strip to which is welded a wide-pore woven or non-woven material which has been precoated with protein nonadsorptive polyurethane. A bioaffinity agent is immobilized on the wide-pore material.

Inventors

  • 👤 Marc Ellous Parham
  • 👤 Santosh Raina
  • 👤 Donald Perry King, Jr.
  • 👤 Diane C. Blinn

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-06 17:41
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54393; G01N33/54366

Claims Analysis

Total Claims: 21
Claim 1
Independent Claim 119 words
A dipstick for assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence of a target analyte in said liquid, said dipstick comprising: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material having a protein nonadsorptive polyurethane coating thereon, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.
Claim 2
Dependent Claim 119 words
A dipstick for assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence of a target analyte in said liquid, said dipstick comprising: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material having a protein nonadsorptive polyurethane coating thereon, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.
Claim 3
Dependent Claim 56 words
The dipstick of Claim 1 in which said support strip has one or more holes adjacent to one end, with one or more pieces of said wide-pore material ultrasonically welded about the perimeter of said hole or holes in such a manner that said hole or holes are at least partially covered by said wide-pore material.
Claim 4
Dependent Claim 68 words
The dipstick of Claims 1 or 2 in which said support has: (i) test area which is a first hole about which is welded wide-pore material having a bioaffinity agent immobilized thereon, and (ii) a positive control area which is a second hole about the perimeter of which is welded a wide-pore material having immobilized thereon a secondary agent reactive with the recognition agent used in the assay.
Claim 5
Dependent Claim 81 words
The dipstick of Claims 1 to 3 in which said support has: (i) a test area which is a first hole about which is welded wide-pore material having a bioaffinity agent immobilized thereon, (ii) a positive control area which is a second hole about which is welded wide-pore material having immobilized thereon a secondary agent reactive with the recognition agent used in the assay, and (iii) a negative control area which is a third hole about which is welded wide-pore material.
Claim 6
Dependent Claim 24 words
The dipstick of Claims 1 to 4 in which said wide-pore material comprises pores with nominal pore size of at least about 10.0 microns.
Claim 7
Dependent Claim 21 words
The dipstick of Claims 1 to 5 in which said bioaffinity agent comprises antibodies, antigens, proteins, RNA probes or DNA probes.
Claim 8
Dependent Claim 48 words
The dipstick of Claims 1 to 6 in which said wide-pore material projects outwardly from said support strip along a midline of said material, and said wide-pore material is ultrasonically welded to said strip along two edges which are substantially parallel to each other and to said midline.
Claim 9
Dependent Claim 53 words
The dipstick of Claims 1 to 7 in which spacers are arranged between said wide-pore material and said support strip along two substantially parallel edges of said wide-pore material such that said wide-pore material is elevated from said strip to create a path for fluid access to both surfaces of said wide-pore material.
Claim 10
Independent Claim 156 words
A method for directly assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence in said liquid of a target analyte by contacting a dipstick comprising a wide-pore woven or non-woven material having a bioaffinity agent immobilized thereon with a test sample of said liquid, a recognition agent-assay conjugate and developing substrate for said recognition agent, wherein said dipstick comprises: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material having a protein nonadsorptive polyurethane coating thereon, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.
Claim 11
Independent Claim 156 words
A method for directly assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence in said liquid of a target analyte by contacting a dipstick comprising a wide-pore woven or non-woven material having a bioaffinity agent immobilized thereon with a test sample of said liquid, a recognition agent-assay conjugate and developing substrate for said recognition agent, wherein said dipstick comprises: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material having a protein nonadsorptive polyurethane coating thereon, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.
Claim 12
Dependent Claim 30 words
The method of Claim 9 in which positive or negative assay results are determined by detecting the presence or absence of color changes on the test area of said dipstick.
Claim 13
Dependent Claim 27 words
The method of Claim 9 in which positive or negative assay results are determined by detecting the presence or absence of color change in the test sample.
Claim 14
Dependent Claim 59 words
The method of Claim 9 which comprises: (a) mixing said recognition agent-assay conjugate with said test sample, (b) incubating said dipstick in said mixture, (c) removing and rinsing said dipstick, (d) incubating said dipstick in developing substrate, (e) removing and rinsing said dipstick, and (f) reading the assay results by determining the presence or absence of a color change.
Claim 15
Dependent Claim 26 words
The method of Claim 12 which comprises manually or mechanically agitating the mixture of test sample and recognition agent-assay conjugate during the incubation of step (b).
Claim 16
Independent Claim 26 words
The method of Claims 9 to 13 in which the container holding said mixture is at an angle of between about 5° and 70° from upright.
Claim 17
Independent Claim 67 words
The method of claims 9 to 14 which comprises (a) incubating said dipstick in said test sample, (b) removing and rinsing said dipstick, (c) incubating said dipstick in recognition agent-assay conjugate solution, (d) removing and rinsing said dipstick, (e) incubating said dipstick in developing substrate, (f) removing and rinsing said dipstick, and (g) reading the assay results by determining the presence or absence of a color change.
Claim 18
Dependent Claim 20 words
The method of Claim 15 which comprises manually or mechanically agitating the test sample during the incubation of step (a).
Claim 19
Independent Claim 27 words
The method of Claims 14 to 16 in which the container holding said test sample is at an angle of between about 5° and 70°C from upright.
Claim 20
Dependent Claim 112 words
A dipstick for assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence of a target analyte in said liquid, said dipstick comprising: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.
Claim 21
Dependent Claim 112 words
A dipstick for assaying a viscous liquid or a liquid which comprises cellular or particulate matter in order to detect the presence of a target analyte in said liquid, said dipstick comprising: (a) a thermoplastic support strip, (b) one or more pieces of wide-pore woven or non-woven material, and (c) one or more bioaffinity agents, wherein said wide-pore material is affixed by ultrasonic welding in a position adjacent to one end of said support strip in such a manner that upon insertion of said dipstick into said liquid, the liquid has access to both surfaces of said wide-pore material, and wherein at least one bioaffinity agent is immobilized on said wide-pore material.

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