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EP0262328A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Chromatographic test strip for determining ligands and receptors

Assignee: Abbott Laboratories
•
Filing: 1987-07-28
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Granted: —
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Expires: 2007-07-28
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Abstract

Abstract The present invention relates to test strips for analysis of analytes such as antigens, antibodies and polynucleotides in a sample by means of a sequential series of reactions. The strip comprises a length of chromatographic material having capillarity and the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive sample components by means of a selected chromatographic solvent. The strip includes a first end, at which chromatographic solvent transport begins, a second end, at which chromatographic solvent transport ends, and a plurality of zones positioned between the first and second ends. The zones include a first zone impregnated with a first reagent which is mobile in the solvent and capable of reaction with and immobilization against solvent transport by the analyte when the analyte is in immobilized form, a second zone for receiving the sample, a third zone, downstream of the first zone, impregnated with a second reagent which is immobilized against solvent transport and which is capable of selective reaction with the analyte so as to render the analyte in an immobilized form in the third zone. The strip also comprises means for detecting the first reagent at the third zone. In addition, the first and second zones are spaced sufficiently from said first end to permit contact of the first end but not the first and second zones with the chromatographic solvent. After the sample is received in the second zone and the first end is dipped into the chromatographic solvent, the relative mobility of the sample components and the first reagent or the site relationship between the second and third zones is such that the analyte is disposed and immobilized against solvent transport at the third zone prior to the first reagent reaching the third zone. Interfering sample components and non-analyte components of the sample which are reactive with the first reagent are cleared from the third zone by chromatographic solvent transport prior to chromatographic solvent transport of the first reagent to the third zone.

Inventors

  • 👤 Julian Gordon
  • 👤 Shanfun Ching
  • 👤 Michael Edward Mcmahon

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-07 08:58
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; B; B01; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5023; B01L2300/00; B01L2300/08; B01L2300/0809; B01L2300/0816; B01L2300/0861; B01L2300/0867; B01L2300/087; B01L2300/0887; B01L2400/00; B01L2400/04; B01L2400/0403; B01L2400/0406; B01L2400/08; B01L2400/084; G01N30/00; G01N30/02; G01N30/26; G01N30/38; G01N30/60; G01N30/6052; G01N30/6065; G01N30/90; G01N30/92; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97; Y10S436/00; Y10S436/807; Y10S436/81

Claims Analysis

Total Claims: 33
Claim 1
Independent Claim 316 words
A test strip for analysis of an analyte in a sample by means of a sequential series of reactions, said strip comprising: a length of chromatographic material having capillarity and the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive sample components by means of a selected chromatographic solvent said strip including, a first end, at which chromatographic solvent transport begins; a second end, at which chromatographic solvent transport ends; a plurality of zones positioned between said first and second ends, said zones including, a first zone impregnated with a first reagent which is mobile in said solvent and capable of reaction with and immobilization against solvent transport by said analyte when said analyte is in immobilized form, a second zone for receiving said sample, a third zone, downstream of said first zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of selective reaction with the analyte so as to render the analyte in an immobilized form in said third zone, means for detecting said first reagent at said third zone, said first and second zones being spaced suf­ficiently from said first end to permit contact of said first end but not said first and second zones with said chromatographic solvent, whereby, after said sample is received in said second zone and said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent or the site relationship between said second and third zones is such that the analyte is disposed and immobilized against solvent transport at the third zone prior to the first reagent reaching the third zone, and whereby interfering sample components and non-analyte components of the sample which are reactive with said first reagent are cleared from said third zone by chromatographic solvent transport prior to chromatographic solvent transport of the first reagent to said third zone.
Claim 2
Dependent Claim 316 words
A test strip for analysis of an analyte in a sample by means of a sequential series of reactions, said strip comprising: a length of chromatographic material having capillarity and the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive sample components by means of a selected chromatographic solvent said strip including, a first end, at which chromatographic solvent transport begins; a second end, at which chromatographic solvent transport ends; a plurality of zones positioned between said first and second ends, said zones including, a first zone impregnated with a first reagent which is mobile in said solvent and capable of reaction with and immobilization against solvent transport by said analyte when said analyte is in immobilized form, a second zone for receiving said sample, a third zone, downstream of said first zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of selective reaction with the analyte so as to render the analyte in an immobilized form in said third zone, means for detecting said first reagent at said third zone, said first and second zones being spaced suf­ficiently from said first end to permit contact of said first end but not said first and second zones with said chromatographic solvent, whereby, after said sample is received in said second zone and said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent or the site relationship between said second and third zones is such that the analyte is disposed and immobilized against solvent transport at the third zone prior to the first reagent reaching the third zone, and whereby interfering sample components and non-analyte components of the sample which are reactive with said first reagent are cleared from said third zone by chromatographic solvent transport prior to chromatographic solvent transport of the first reagent to said third zone.
Claim 3
Dependent Claim 26 words
The test strip according to claim 1 wherein said means for detecting said first reagent at said third zone is a label on said first reagent.
Claim 4
Dependent Claim 23 words
The test strip according to claim 2 wherein said label is selected from the group consisting of radiolabels, chromophores, fluorophores and enzyme labels.
Claim 5
Dependent Claim 13 words
The test strip according to claim 1 com­prising multiple chromatographic solvent transport path­ways.
Claim 6
Dependent Claim 24 words
The test strip according to claim 4 wherein the chromatographic solvent transport pathways of said sample and of said first reagent are partially non-coincident.
Claim 7
Dependent Claim 61 words
The test strip according to claim 3 wherein said label is an enzyme label and a third reagent reactive with said label is disposed at a fourth zone and has a relative mobility in said chromatographic solvent such that the third reagent is transported to said third zone by said solvent after said first reagent is transported to said third zone.
Claim 8
Dependent Claim 15 words
The test strip according to claim 4 wherein said third reagent is an indicator substance.
Claim 9
Dependent Claim 24 words
The test strip according to claim 6 wherein the chromatographic solvent transport pathways of said first reagent and said third reagent are par­tially non-coincident.
Claim 10
Dependent Claim 20 words
The test strip according to claim 4 wherein said pathways of travel are separated by means of solvent impermeable barriers.
Claim 11
Dependent Claim 17 words
The test strips according to claim 9 wherein said solvent impermeable barriers are formed by laser etching.
Claim 12
Dependent Claim 16 words
The test strips according to claim 1 wherein said chromatographic material is thin layer chromatographic material.
Claim 13
Dependent Claim 15 words
The test strips according to claim 11 wherein said thin layer chromatographic material is nitrocellulose.
Claim 14
Dependent Claim 13 words
The test strips according to claim 1 wherein said analyte is an antibody.
Claim 15
Dependent Claim 13 words
The test strips according to claim 1 wherein said analyte is an antigen.
Claim 16
Dependent Claim 13 words
The test strips according to claim 1 wherein said analyte is a polynucleotide.
Claim 17
Independent Claim 340 words
A method for analysis of analyte in a sample by means of a sequential series of reactions, said method employing: a strip comprising a length of chromatographic material having capillarity and the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive sample components by means of a selected chromatographic solvent said strip including, a first end, at which chromatographic solvent transport begins; a second end, at which chromatographic solvent transport ends; a plurality of zones positioned between said first and second ends, said zones including, a first zone impregnated with a first reagent which is mobile in said solvent and capable of reaction with and immobilization against solvent transport by said analyte when said analyte is in immobilized form, a second zone for receiving said sample a third zone, downstream of said first zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of selective reaction with the analyte so as to render the analyte in an immobilized form in said third zone, means for detecting said first reagent at said third zone, said first and second zones being spaced suf­ficiently from said first end to permit contact of said first end but not said first and second zones with said chromatographic solvent, said method comprising: (1) disposing said sample in said second zone; (2) dipping said first end into said chromatographic solvent for a time sufficient to chromatographically transport said analyte and said first reagent to said third zone, the relative mobility of said analyte and said first reagent or the site relationship between said second and third zones being such that the analyte is disposed at the third zone prior to the first reagent reaching the third zone and whereby interfering sample substances and non-analyte components of the sample which are reactive with said first reagent are cleared from said third zone by the chromatographic solvent prior to the arrival of the first reagent; and (3) detecting the presence of said first reagent or said reaction product in said third zone.
Claim 18
Independent Claim 340 words
A method for analysis of analyte in a sample by means of a sequential series of reactions, said method employing: a strip comprising a length of chromatographic material having capillarity and the capacity for rapid chromatographic solvent transport of non-immobilized reagents and reactive sample components by means of a selected chromatographic solvent said strip including, a first end, at which chromatographic solvent transport begins; a second end, at which chromatographic solvent transport ends; a plurality of zones positioned between said first and second ends, said zones including, a first zone impregnated with a first reagent which is mobile in said solvent and capable of reaction with and immobilization against solvent transport by said analyte when said analyte is in immobilized form, a second zone for receiving said sample a third zone, downstream of said first zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of selective reaction with the analyte so as to render the analyte in an immobilized form in said third zone, means for detecting said first reagent at said third zone, said first and second zones being spaced suf­ficiently from said first end to permit contact of said first end but not said first and second zones with said chromatographic solvent, said method comprising: (1) disposing said sample in said second zone; (2) dipping said first end into said chromatographic solvent for a time sufficient to chromatographically transport said analyte and said first reagent to said third zone, the relative mobility of said analyte and said first reagent or the site relationship between said second and third zones being such that the analyte is disposed at the third zone prior to the first reagent reaching the third zone and whereby interfering sample substances and non-analyte components of the sample which are reactive with said first reagent are cleared from said third zone by the chromatographic solvent prior to the arrival of the first reagent; and (3) detecting the presence of said first reagent or said reaction product in said third zone.
Claim 19
Dependent Claim 25 words
A method according to claim 16 wherein said means for detecting said first reagent at said third zone is a label on said first reagent.
Claim 20
Dependent Claim 27 words
A method according to claim 16 wherein said means for detecting said first reagent at said third zone is a fourth reagent reactive with said first reagent.
Claim 21
Dependent Claim 14 words
A method according to claim 18 wherein the fourth reagent is an indicator substance.
Claim 22
Dependent Claim 34 words
A method according to claim 18 wherein said third reagent is disposed at a fourth zone and is chromatographically transported to said third zone after said first reagent is transported to said third zone.
Claim 23
Dependent Claim 15 words
A method according to claim 16 wherein said test strip comprises multiple chromatographic solvent pathways.
Claim 24
Dependent Claim 24 words
A method according to claim 21 wherein said first reagent and said third reagent are trans­ported along pathways of travel which are partially non-­coincident.
Claim 25
Dependent Claim 23 words
A method according to claim 20 wherein said sample and said third reagent are transported along pathways of travel which are partially non-coincident.
Claim 26
Dependent Claim 21 words
A method according to claim 21 wherein said chromatographic solvent pathways are partially non-­coincident as a result of solvent impermeable barriers.
Claim 27
Dependent Claim 16 words
A method according to claim 16 wherein said second zone is coincident with said third zone.
Claim 28
Dependent Claim 15 words
A method according to claim 16 wherein said chromatographic material is thin layer chromato­graphic material.
Claim 29
Dependent Claim 14 words
A method according to claim 26 wherein said thin layer chromatographic material is nitrocel­lulose.
Claim 30
Dependent Claim 25 words
A method according to claim 26 wherein said nitrocellulose is characterized by an average pore size ranging from about 0.1 micron to about 1 micron.
Claim 31
Dependent Claim 12 words
A method according to claim 16 wherein said analyte is an antibody.
Claim 32
Dependent Claim 12 words
A method according to claim 16 wherein said analyte is an antigen.
Claim 33
Dependent Claim 12 words
A method according to claim 16 wherein said analyte is a polynucleotide.

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