EP0267006A2
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EP
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Qualitative immunochromatographic method and device
Assignee: Syntex USA LLC
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Filing: 1987-11-03
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Granted: —
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Expires: 2007-11-03
Abstract
Abstract A method for determining the presence of a predetermined minimum detectible amount of one or more analytes in a sample suspected of containing the analyte is disclosed. Each analyte is a member of a specific binding pair ("sbp member") consisting of ligand and its complementary receptor. The method comprises contacting with a test solution containing said sample and predetermined amounts of two or more of a plurality of first sbp members, each respectively analogous to one of said analytes, a contact portion of a piece of bibulous material capable of being traversed in at least one direction by the test solution by capillary migration. The bibulous material contains predetermined amounts of two or more of a plurality of second sbp members, each respectively capable of binding one of the analytes and corresponding first sbp member. The second sbp members are non-diffusively bound to the bibulous material at least between the contact portion and a predetermined site on the piece of bibulous material separated from the contact portion such that in the presence of a predetermined amount of one or more analytes the analogous first sbp member migrates at least to the predetermined site on the piece of bibulous material. Next, at least a portion of the test solution is allowed to traverse the bibulous material by means of capillary migration. The predetermined site is examined for the presence of one or more of the first sbp members, which is usually indicated by the presence of a detectible signal. Such signal can be directly detectible, or the predetermined site can be exposed to a signal producing means capable of interacting with the first sbp members to produce a detectible signal at the predetermined site in relation to the amount of one or more of the analytes in the sample.
Inventors
- 👤 David J. Litman
- 👤 Thomas M. Li
- 👤 Laura Lee Buelteman
- 👤 Emmy Tong-In Wong
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-31 10:12
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/94; G01N33/948; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; G01N33/9486; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97; Y10S436/00; Y10S436/805; Y10S436/807; Y10S436/81; Y10S436/815; Y10S436/816; Y10S436/822
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
219 words
A method for determining the presence at or above a predetermined minimum detectable amount of one or more of a plurality of analytes in a sample suspected of containing one or more of said analytes, each analyte being 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 predetermined amount of two or more first sbp members each respectively analogous to one of said analytes, a contact portion of a piece of bibulous material capable of being traversed in at least one direction by said test solution by capillary migration, said bibulous material having substantially uniformly and non-diffusively bound thereto predetermined amounts of two or more second sbp members each respectively capable of binding one of said analytes and said first sbp members such that in the presence of a predetermined amount of each analyte the analogous first sbp member migrates at least to a predetermined site on said piece of bibulous material from said contact portion, (b) allowing at least a portion of the test solution to traverse said bibulous material by means of capillary migration at least to said predetermined site, and (c) detecting one or more of said first sbp members at said predetermined site.
Claim 2
Independent Claim
219 words
A method for determining the presence at or above a predetermined minimum detectable amount of one or more of a plurality of analytes in a sample suspected of containing one or more of said analytes, each analyte being 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 predetermined amount of two or more first sbp members each respectively analogous to one of said analytes, a contact portion of a piece of bibulous material capable of being traversed in at least one direction by said test solution by capillary migration, said bibulous material having substantially uniformly and non-diffusively bound thereto predetermined amounts of two or more second sbp members each respectively capable of binding one of said analytes and said first sbp members such that in the presence of a predetermined amount of each analyte the analogous first sbp member migrates at least to a predetermined site on said piece of bibulous material from said contact portion, (b) allowing at least a portion of the test solution to traverse said bibulous material by means of capillary migration at least to said predetermined site, and (c) detecting one or more of said first sbp members at said predetermined site.
Claim 3
Dependent Claim
57 words
The method of Claim 1 wherein said first sbp member is detected by exposing said bibulous material to a signal producing means capable of interacting with said first sbp members to produce a detectible signal, the presence of said signal at said predetermined site indicating the presence of one or more of said analytes in said sample.
Claim 4
Dependent Claim
33 words
The method of Claim 1 or 2 wherein the presence of said first sbp member at said predetermined site is detected directly by examining said predetermined site for the presence of a signal.
Claim 5
Dependent Claim
15 words
The method of Claim 1, 2 or 3 wherein said strip is a paper strip.
Claim 6
Independent Claim
23 words
The method of any one of the preceding Claims wherein each of said second sbp members is a respective antibody for an analyte.
Claim 7
Independent Claim
22 words
The method of any one of the preceding Claims wherein each of said first sbp members is respectively conjugated to a label.
Claim 8
Dependent Claim
11 words
The method of Claim 6 wherein said label is an enzyme.
Claim 9
Dependent Claim
42 words
The method of Claim 7 wherein a second enzyme is bound uniformly to said bibulous material at least over an area including said predetermined site, the enzymes being related in that the product of one enzyme is the substrate for the other.
Claim 10
Independent Claim
49 words
The method of any one of the preceding Claims wherein each of the analytes is a drug, each of said first sbp members is a corresponding drug analog conjugated to a label, and each of said second sbp members is respectively a corresponding antibody to one of said drugs.
Claim 11
Independent Claim
27 words
The method of any one of the preceding Claims wherein said test solution is allowed to traverse said bibulous material past said predetermined site in step (b).
Claim 12
Independent Claim
35 words
The method of any one of the preceding Claims wherein said bibulous material contains means associated therewith for allowing detection of one or more of a said first sbp members only at said predetermined site.
Claim 13
Dependent Claim
25 words
The method of Claim 11 wherein said means conceals from view the portion of the bibulous material between said contact portion and said predetermined site.
Claim 14
Dependent Claim
200 words
A method according to Claim 1 for determining the presence at or above a predetermined minimum detectible amount of one or more of a plurality of analytes in a sample suspected of containing one or more of said analytes, which method comprises - (a) contacting, with a test solution containing said sample and a predetermined amount of two or more analyte analogs each conjugated to an enzyme, the end portion of a strip of bibulous material capable of being traversed by said test solution by capillary migration, said strip having substrantially uniformly and non-diffusively bound thereto predetermined amounts of two or more antibodies, each respectively capable of binding one of said analyte analogs and its corresponding analyte, such that in the presence of a predetermined amount of each analyte the corresponding analyte analog migrates at least to a predetermined site on said strip separated from said end portion, (b) allowing at least a portion of the test solution to traverse said strip past said predetermined site by capillary migration, and (c) examining said predetermined site for the presence of one or more of said analyte analogs, the presence thereof indicating the presence of one or more analytes in said sample.
Claim 15
Independent Claim
179 words
A device for determining the presence at or above a predetermined minimum amount of one or more of a plurality of analytes in a test solution containing predetermined amounts of two or more first sbp members, each respectively analogous to one of said analytes, each analyte being a member of a specific binding pair, said device comprising- a piece of bibulous material capable of traversal by said test solution in at least one direction by capillary migration, said bibulous material having a contact portion of contacting said test solution and predetermined amounts of two or more second sbp members each respectively complementary to one of said analytes substantially uniformly and non-diffusively bound to said bibulous material, said predetermined amounts of said second sbp members being such that in the presence of at least one of said analytes a first sbp member migrates to a predermined site on said bibulous material separated from said contact portion, and means associated with said bibulous material for allowing detection of one or more of said first sbp members only at said predetermined site.
Claim 16
Independent Claim
179 words
A device for determining the presence at or above a predetermined minimum amount of one or more of a plurality of analytes in a test solution containing predetermined amounts of two or more first sbp members, each respectively analogous to one of said analytes, each analyte being a member of a specific binding pair, said device comprising- a piece of bibulous material capable of traversal by said test solution in at least one direction by capillary migration, said bibulous material having a contact portion of contacting said test solution and predetermined amounts of two or more second sbp members each respectively complementary to one of said analytes substantially uniformly and non-diffusively bound to said bibulous material, said predetermined amounts of said second sbp members being such that in the presence of at least one of said analytes a first sbp member migrates to a predermined site on said bibulous material separated from said contact portion, and means associated with said bibulous material for allowing detection of one or more of said first sbp members only at said predetermined site.
Claim 17
Dependent Claim
75 words
A kit for use in determining the presence of an analyte in a test solution, said kit comprising in a packaged combination-- (a) the device of Claim 14 (b) two or more of said first sbp members as part of a signal producing system, (c) other members of said signal producing system for producing a detectible signal in the presence of one or more of said analytes as required, and (d) ancillary materials as required.
References Cited (Backward Citations)
No citation records indexed.
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