Qualitative immunochromatographic method and device
First Claim
1. A method 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, 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 predetermined amounts 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 separated 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.
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Accused Products
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 the sample and predetermined amounts of two or more of a plurality of first sbp members, each respectively analogous to one of the 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 transverse 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.
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Citations
36 Claims
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1. A method 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, 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 predetermined amounts 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 separated 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.
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20. A method 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 substantially 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.
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35. 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 for contacting said test solution and a predetermined site separated from said contact portion 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 at least between said contact portion and said predetermined site, said predetermined amounts of said second sbp members being such that in the presence at or above a predetermined minimum detectible amount of at least one of said analytes a first sbp member migrates to said predetermined site on said bibulous material and means associated with said bibulous material for allowing detection of one or more of said first sbp members only at said predetermined site, wherein each of said sbp members is respectively conjugated to an enzyme and said means is a second enzyme bound to said bibulous material only at said predetermined site, the enzymes being related in that the product of one enzyme is the substrate for the other.
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36. 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 for contacting said test solution and a predetermined site separated from said contact portion and predetermined amounts of two or more second sbp members each respectively complementary to one of said analytes substantially uniformily and non-diffusively bound to said bibulous material at least between said contact portion and said predetermined site, said predetermined amounts of said second sbp members being such that in the presence at or above a predetermined minimum detectible amount of at least one of said analytes a first sbp member migrates to said predetermined site on said bibulous material and means associated with said bibulous material for allowing detection of one or more of said first sbp members only at said predetermined site, wherein said means is a signal inhibitor bound to said strip between said contact portion and said predetermined site.
Specification