Concentrating immunochemical test device and method
First Claim
1. A method for determining the presence of an analyte in a sample suspected of containing said analyte, which method comprises(a) providing in combination (1) a liquid medium containing said sample and a first sbp member and (2) a portion of bibulous material capable of being traversed by said liquid medium by capillary migration,said bibulous material containing a second sbp member non-diffusively bound to a small situs on said bibulous material separated from said portion, the surface area of said situs being substantially less than that of said bibulous material,said second sbp member having the characteristic of binding said first sbp memberwherein a third sbp member capable of binding said first sbp member is non-diffusively bound to said bibulous material at least between said small situs and said portion,(b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and(c) detecting the presence or absence of the first sbp member at said situs.
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Accused Products
Abstract
A method and device for determining the presence of an analyte in a sample suspected of containing the analyte is disclosed. The method involves contacting a test solution containing the sample and a first member of a specific binding pair with an end portion of a strip of bibulous material capable of being traversed by the test solution through capillary action. The first member of a specific binding pair is capable of binding the analyte. The strip contains a second member of a specific binding pair integral therewith for concentrating and non-diffusively binding the first sbp member at a small situs on the strip separated from the end portion of the strip. The detectible signal is produced in relation to the presence of the analyte in the test solution. The test solution passes through the situs as the test solution traverses the bibulous material. After the test solution has been allowed to traverse at least a portion of the strip, the strip is contacted with a developer solution containing members of a signal producing system in a manner that provides contact of the developer solution with the small situs following its contact with the test solution. The strip is then contacted with any remaining members of the signal producing system. The detectible signal produced at the situs is then compared with the signal detectible at a portion of the strip other than the situs to determine the analyte in the sample. In one embodiment of the invention the signal produced at the small situs has a sharp-edged distinctive pattern that provides a sharp contrast to the signal produced at adjacent sites on the strip when analyte is present in the test solution.
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Citations
129 Claims
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1. A method for determining the presence of an analyte in a sample suspected of containing said analyte, which method comprises
(a) providing in combination (1) a liquid medium containing said sample and a first sbp member and (2) a portion of bibulous material capable of being traversed by said liquid medium by capillary migration, said bibulous material containing a second sbp member non-diffusively bound to a small situs on said bibulous material separated from said portion, the surface area of said situs being substantially less than that of said bibulous material, said second sbp member having the characteristic of binding said first sbp member wherein a third sbp member capable of binding said first sbp member is non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp member at said situs.
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10. A method for determining the presence of an analyte in a sample suspected of containing said analyte, which comprises
(a) contacting, with a test solution containing said sample and a first sbp member, a contact portion of bibulous material capable of being traversed by said test solution by capillary migration, said bibulous material containing a second sbp member non-diffusively bound to a small situs on said bibulous material separate from said contact portion, the surface area of said situs being substantially less than that of said bibulous material, said second sbp member having the characteristic of binding said first sbp member wherein a third sbp member capable of binding said first sbp member is non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp member at said situs.
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19. A method for determining the presence of one or more of a plurality of analytes in a sample suspected of containing said analytes, which method comprises
(a) providing in combination (1) a liquid medium containing said sample and a plurality of first sbp members and (2) a portion of bibulous material capable of being traversed by said liquid medium by capillary migration, said bibulous material containing a plurality of second sbp members each non-diffusively bound to a small situs on said bibulous material separated from said portion, the surface area of said situses being substantially less than that of said bibulous material, each of said second sbp members having the characteristic of binding a corresponding first sbp member wherein a plurality of third sbp members each capable of binding one of said first sbp members are non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp members at said situses.
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27. A method for determining the presence of one or more of a plurality of analytes in a sample suspected of containing said analyte, which comprises
(a) contacting, with a test solution containing said sample and a plurality of first sbp members, a contact portion of bibulous material capable of being traversed by said test solution by capillary migration, said bibulous material containing a plurality of second sbp members each non-diffusively bound to a small situs on said bibulous material separate from said contact portion, the surface area of each of said situses being substantially less than that of said bibulous material, each of said second sbp members having the characteristic of binding a corresponding first sbp member wherein a plurality of third sbp members each capable of binding one of said first sbp members are non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp member at said situs.
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35. A method for determining the presence of one or more of a plurality of analytes in a sample suspected of containing said analytes, which comprises
(a) contacting, with a test solution containing said sample and a plurality of antibodies each corresponding to one of said analytes, and each of said antibodies being conjugated to a label (antibodies--labels), a contact portion of bibulous material capable of being traversed by said test solution by capillary migration, said bibulous material containing sets of particles, each of said sets being non-diffusively bound to a small situs on said bibulous material separate from said contact portion, the surface area of said situs being substantially less than that of said bibulous material, said particles having a plurality of sets of members of specific binding pairs ("sbp members") non-diffusively bound thereto, each set of sbp members being respectively capable of binding to one of said antibodies to said analyte when said antibodies are bound to said analyte, with the proviso that, where said sbp members are able of binding said antibodies to said analyte when said antibodies are not bound to said analyte, a plurality of analogs of said analytes each capable of binding to one of said antibodies to said analyte are non-diffusively bound to said bibulous material between said small situs and said contact portion, (b) allowing the test solution to traverse at least a portion of said bibulous material by capillary migration, and (c) detecting the presence or absence of said antibodies-labels at the situs.
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40. A method for determining the presence of an analyte in a sample suspected of containing said analyte, which comprises
(a) contacting, with a test solution containing said sample and a first sbp member, a contact portion of bibulous material capable of being traversed by said test solution by capillary migration, said bibulous material containing particles non-diffusively bound to a small situs on said bibulous material separate from said contact portion, the surface area of said situs being substantially less than that of said bibulous material, said particles having a member of a specific binding pair ("sbp member") non-diffusively bound thereto, which sbp member is capable of binding to said antibodies to said analyte when said antibodies are bound to said analyte, with the proviso that, where said sbp member is able to bind said antibodies to said analyte when said antibodies are not bound to said analyte, an analog of said analyte capable of binding said antibodies to said analyte is non-diffusively bound to said bibulous material between said small situs and said contact portion, (b) allowing said test solution to traverse at least a portion of said bibulous material by capillary migration, and (c) detecting the presence or absence of said antibodies at said situs.
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50. A method for determining the presence of an analyte in sample suspected of containing said analyte, which analyte is a member of a specific binding pair ("sbp member") consisting of ligand and its complementary receptor, which method comprises
(a) providing in combination (1) a liquid medium containing said sample and a first sbp member capable of binding to said analyte, and (2) a portion of bibulous material capable of being traversed by said liquid medium by capillary migration, said bibulous material containing a second sbp member non-diffusively bound to a small situs on said bibulous material separated from said portion, the surface area of said situs being substantially less than that of said bibulous material, said second sbp member having the characteristic of binding said first sbp member when said first sbp member is bound to said analyte, with the proviso that, where said second sbp member is able to bind said first sbp member when said first sbp member is not bound to said analyte, an analyte analog capable of binding said first sbp member is non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp member at said situs.
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59. A method for determining the presence of an analyte, which comprises
(a) providing in combination (1) a liquid medium containing said analyte and antibodies to said analyte, said antibodies being conjugated to a label, and (2) a portion of a strip of bibulous material capable of being traversed by said liquid medium by capillary migration, said bibulous material containing particles non-diffusively bound to a small situs on said bibulous material separate from said portion, the surface area of said situs being substantially less than that of said bibulous material, said particles having a member of a specific binding pair ("sbp member") non-diffusively bound thereto, which sbp member is capable of binding to said antibodies to said analyte when said antibodies are bound to said analyte, with the proviso that, where said sbp member is able to bind said antibodies to said analyte when said antibodies are not bound to said analyte, an analog of said analyte capable of binding said antibodies to said analyte is non-diffusively bound to said bibulous material between said small situs and said portion, (b) allowing the liquid medium to traverse at least a portion of said bibulous material by capillary migration, and (c) detecting the presence or absence of said first sbp member at the situs.
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69. A method for determining the presence of an analyte, which method comprises
(a) providing in combination (1) a liquid medium containing said analyte and a first sbp member capable of binding to said analyte, and (2) a portion of bibulous material capable of being traversed by said liquid medium by capillary migration, said bibulous material containing a second sbp member non-diffusively bound to a small situs on said bibulous material separated from said portion, the surface area of said situs being substantially less than that of said bibulous material, said second sbp member having the characteristic of binding said first sbp member when said first sbp member is bound to said analyte, with the proviso that, where said second sbp member is able to bind said first sbp member when said first sbp member is not bound to said analyte, an analyte analog capable of binding said first sbp member is non-diffusively bound to said bibulous material at least between said small situs and said portion, (b) allowing said liquid medium to traverse at least a portion of said bibulous material by means of capillary migration, and (c) detecting the presence or absence of the first sbp member at said situs.
- 78. A device for determining the presence of an analyte, which device comprises a bibulous material, the pores of at least a portion of which have particles infiltrated in the form of a pattern therein, said particles having a member of a specific binding pair non-diffusively bound thereto.
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92. A device for determining the presence of an analyte in a test solution comprised of a first member of a specific binding pair and a sample of containing the analyte, which comprises
bibulous material capable of traversal by said test solution by capillary migration, said bibulous material having a first portion for contacting said test solution ("contact portion") and a second sbp member non-diffusively bound to a second portion of said bibulous material, separated from said contact portion, the surface area of said second portion being substantially less than that of said bibulous material, said second sbp member having the characteristic of binding said first sbp member, and a third sbp member, capable of binding said first sbp member, non-diffusively bound to said bibulous material at least between said second portion and said contact portion.
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102. A device for determining the presence of an analyte in a test solution comprised of a first specific binding pair (sbp) member and a sample suspected of containing said analyte, which comprises
a strip of bibulous material capable of being traversed by said test solution by capillary migration, said strip having an end portion for contacting said test solution and a second sbp member non-diffusively bound to said strip at a small situs separated from said end portion, said situs having a surface area substantially less than that of said strip, through which situs said test solution passes as it traverses said strip, and a third sbp member, capable of binding said first sbp member, non-diffusively bound to said strip at least between said small situs and said end portion.
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113. A multizone test device for the specific binding assay determination of an analyte in a liquid test medium involving binding among (i) the analyte, (ii) a labeled or immobilized form of the analyte or of a binding analog thereof, and (iii) an immobilized or labeled form, respectively, of a binding partner of the analyte;
- the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group having a detectable physical property, the test device comprising, in fluid flow contact,
(1) a reagent zone comprising a solid, porous matrix incorporated with an immobilized one of the analyte, analog thereof, or binding partner, and (2) a detection zone comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into said detection zone and incorporated with an immobilized form of a binding substance for the labeled reagent. - View Dependent Claims (114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129)
- the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group having a detectable physical property, the test device comprising, in fluid flow contact,
Specification