Patent EP0191640A2 successfully refreshed from Google Patents.
EP0191640A2
Expired / Lapsed
EP
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Concentrating immunochemical test strip
Assignee: Abbott Laboratories
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Filing: 1986-02-13
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Granted: —
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Expires: 2006-02-13
Abstract
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.
Inventors
- 👤 David Calderhead
- 👤 Pyare Khanna
- 👤 Edwin Fisher Ullman
- 👤 Litai Weng
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-02 21:12
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54313; G01N33/536; G01N33/537; G01N33/538; G01N33/542; G01N33/54366; G01N33/54386; G01N33/54387; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/966; Y10S435/97; Y10S435/973; Y10S435/975; Y10S436/00; Y10S436/807; Y10S436/81; Y10S436/811; Y10S436/814; Y10S436/815; Y10S436/817; Y10S436/818
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
312 words
A method for determining the presence of an analyte in a 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) contacting, with a test solution containing said sample and a first sbp member capable of binding to said analyte, the end portion of a strip of bibulous material capable of being traversed by said test solution by capillary migration, said strip containing a second sbp member non-diffusively bound to a small situs on said strip separated from said end portion, the surface area of said situs being substantially less than that of said strip, said second sbp member having the characteristic of binding a complex formed by 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 in said complex to said analyte, an analyte analog capable of binding said first sbp member is non-diffusively bound to said strip at least between said small situs and said end portion, (b) allowing the test solution to traverse at least a portion of said strip by means of capillary migration, (c) contacting said strip (1) with a developer solution containing members of a signal producing system to provide contact of said developer solution with said situs following contact of said test solution with said situs and (2) with any remaining members of said signal producing system, said signal producing system being capable of producing a detectible signal at said situs in relation to the amount of analyte in said sample, and (d) comparing said detectible signal at said situs with the signal detectible at a portion of the strip other than at said situs.
Claim 2
Independent Claim
312 words
A method for determining the presence of an analyte in a 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) contacting, with a test solution containing said sample and a first sbp member capable of binding to said analyte, the end portion of a strip of bibulous material capable of being traversed by said test solution by capillary migration, said strip containing a second sbp member non-diffusively bound to a small situs on said strip separated from said end portion, the surface area of said situs being substantially less than that of said strip, said second sbp member having the characteristic of binding a complex formed by 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 in said complex to said analyte, an analyte analog capable of binding said first sbp member is non-diffusively bound to said strip at least between said small situs and said end portion, (b) allowing the test solution to traverse at least a portion of said strip by means of capillary migration, (c) contacting said strip (1) with a developer solution containing members of a signal producing system to provide contact of said developer solution with said situs following contact of said test solution with said situs and (2) with any remaining members of said signal producing system, said signal producing system being capable of producing a detectible signal at said situs in relation to the amount of analyte in said sample, and (d) comparing said detectible signal at said situs with the signal detectible at a portion of the strip other than at said situs.
Claim 3
Dependent Claim
25 words
The method of Claim 1 wherein particles are non-diffusively bound to said strip at said situs, said particles being conjugated to said second sbp member.
Claim 4
Dependent Claim
27 words
The method of Claim 1 or 2 wherein the small situs is a band transverse to the direction of traversal of said test solution along said strip.
Claim 5
Dependent Claim
43 words
The method of Claim 1, 2 or 3 wherein the signal produced at the small situs has a sharp-edged distinctive pattern that provides a sharp contrast to signal produced at adjacent sites on the strip when analyte is present in said test solution.
Claim 6
Independent Claim
54 words
The method of any one of the preceding claims wherein a second enzyme is bound uniformly to said strip at least over an area including said situs and the portions of the strip adjacent to said situs, the enzymes being related in that the product of one enzyme is the substrate for the other.
Claim 7
Independent Claim
77 words
The method of any one of the preceding claims for determining the presence of a plurality of analytes in said test solution, wherein a plurality of second sbp members are each non-diffusively bound to a small situs on said strip distant from said end portion wherein each of said second sbp members is respectively capable of specifically binding a corresponding first sbp member and said first sbp members are combined with said sample in said test solution.
Claim 8
Independent Claim
284 words
A method according to anyone of the preceding claims 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 antibodies to said analyte, the end portion of a strip of bibulous material capable of being traversed by said test solution by capillary migration, said strip containing particles non-diffusively bound to a small situs on said strip separate from said end portion, the surface area of said situs being substantially less than that of said strip, to which particles a member of a specific binding pair ("sbp member") is non-diffusively bound, which is capable of binding to a complex formed by said antibodies and said analyte with the proviso that, where said sbp member is able to bind said antibodies when said antibodies are not bound in said complex to said analyte, an analog of said analyte capable of binding said antibodies is non-diffusively bound to said strip between said small situs and said end portion, (b) allowing the test solution to traverse at least a portion of said strip by capillary migration, (c) contacting said strip (1) with a developer solution containing members of a signal producing system to provide contact of said developer solution with said situs following contact of said test solution with said situs and (2) with any remaining members of said signal producing system, said signal producing system being capable of producing a detectible signal at said situs in relation to the amount of analyte in the test solution, and (d) comparing said detectible signal at said situs with the signal detectible at a portion of the strip other than said situs.
Claim 9
Independent Claim
18 words
The method according to anyone of the preceding claims wherein said antibodies are antibodies for human chorionic gonadotropin.
Claim 10
Independent Claim
72 words
The method of anyone of the preceding claims for determining a plurality of analytes in said sample, wherein a mixture of specific antibodies to each analyte is combined with the sample and a plurality of sets of particles is non-diffusively bound to said strip, each set of particles having non-diffusively bound thereto an sbp member capable of binding at least one of the complexes formed between a specific antibody and an analyte.
Claim 11
Dependent Claim
19 words
The method of Claim 9 wherein an analyte analog for each of said analytes is bound to said strip.
Claim 12
Independent Claim
187 words
A device for determining the presence of an analyte in a test solution comprised of a first member of a specific binding pair (sbp member) complementary to said analyte and a sample suspected of containing the analyte, which comprises - a bibulous strip capable of traversal by said test solution by capillary migration, said strip having an end portion for contacting said test solution and a second sbp member different than said analyte non-diffusively bound to a small situs on said strip separated from said end portion, the surface area of said situs being substantially less than that of said strip, said second sbp member having the characteristic of binding a complex formed by 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 in said complex to said analyte, an analog of said analyte capable of binding said first sbp member is non-diffusively bound to said strip at least between said small situs and said end portion.
Claim 13
Independent Claim
187 words
A device for determining the presence of an analyte in a test solution comprised of a first member of a specific binding pair (sbp member) complementary to said analyte and a sample suspected of containing the analyte, which comprises - a bibulous strip capable of traversal by said test solution by capillary migration, said strip having an end portion for contacting said test solution and a second sbp member different than said analyte non-diffusively bound to a small situs on said strip separated from said end portion, the surface area of said situs being substantially less than that of said strip, said second sbp member having the characteristic of binding a complex formed by 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 in said complex to said analyte, an analog of said analyte capable of binding said first sbp member is non-diffusively bound to said strip at least between said small situs and said end portion.
Claim 14
Dependent Claim
25 words
The device of Claim 11 wherein particles are non-diffusively bound to said strip at said situs, said particles being conjugated to said second sbp member.
Claim 15
Dependent Claim
68 words
The device of Claim 11 or 12 for determining the presence of a plurality of analytes in said test solution wherein each of a set of second sbp members is respectively non-diffusively bound to a different small situs on said strip separate from said end portion wherein each set of sbp member is capable of binding to a specific complex of an analyte and a first sbp member.
Claim 16
Dependent Claim
53 words
A kit for use in determining the presence of an analyte in a test solution, comprising in a packaged combination-- (a) the device of Claim 11, (b) other members of a signal producing system for producing a detectible signal in the presence of said analyte as required, and (c) ancillary materials as required.
Claim 17
Independent Claim
68 words
A method for non-diffusively binding a member of specific binding pair ("sbp" member) on bibulous material, which method comprises applying, in a pattern on said bibulous material, particles to which said sbp members are non-diffusively bound, the size of said particles being small enough to allow said particles to infiltrate the pores of said bibulous material but large enough to prevent said particles from diffusing from said pores.
Claim 18
Independent Claim
68 words
A method for non-diffusively binding a member of specific binding pair ("sbp" member) on bibulous material, which method comprises applying, in a pattern on said bibulous material, particles to which said sbp members are non-diffusively bound, the size of said particles being small enough to allow said particles to infiltrate the pores of said bibulous material but large enough to prevent said particles from diffusing from said pores.
References Cited (Backward Citations)
No citation records indexed.
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