Patent US4960691A successfully refreshed from Google Patents.
US4960691A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Chromatographic test strip for determining ligands or receptors
Assignee: Abbott Laboratories
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Filing: 1986-09-29
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Granted: 1990-10-02
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Expires: 2006-09-29
Abstract
Abstract A test strip for analysis of analytes such as antigens, antibodies or polynucleotides employs a chromatographic medium and a solvent capable of transporting reagents and/or sample. Reagents are selected and disposed on the medium such that a labeled (first) reagent arrives at the detection (third) zone only after analyte is immobilized there and non-reactive sample componets have been transported beyond the detection zone. This sequential arrival is accomplished by the relative mobility of the reagent or sample; or by the site relationship of the zones. Preferably, the site relationship of the sample (second) zone and the label (first) zone is such that a plurality of pathways guide the sample and labeled reagent and any subsequent reagents to the detection zone in the recited order. Single and multiple pathway devices are disclosed.
Inventors
- 👤 Julian Gordon
- 👤 Michael E. McMahon
- 👤 Shanfun Ching
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 13:31
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: 36
Claim 1
Independent Claim
305 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 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 chromatographic solvent transport pathways; 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 a specific binding reaction with said analyte, a second zone for receiving said sample, and a third zone, downstream of said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for detecting said first reagent at said third zone as a measure of the analyte, whereby, after said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent is controlled by said plurality of chromatographic solvent transport pathways such that the analyte is transported to 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 the first reagent reaching said third zone.
Claim 2
Dependent Claim
305 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 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 chromatographic solvent transport pathways; 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 a specific binding reaction with said analyte, a second zone for receiving said sample, and a third zone, downstream of said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for detecting said first reagent at said third zone as a measure of the analyte, whereby, after said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent is controlled by said plurality of chromatographic solvent transport pathways such that the analyte is transported to 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 the first reagent reaching 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
24 words
The test strip according to claim 1 wherein the chromatographic solvent transport pathways of said sample and of said first reagent are partially non-coincident.
Claim 6
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 7
Dependent Claim
15 words
The test strip according to claim 5 wherein said third reagent is an indicator substance.
Claim 8
Dependent Claim
24 words
The test strip according to claim 5 wherein the chromatographic solvent transport pathways of said first reagent and said third reagent are partially non-coincident.
Claim 9
Dependent Claim
21 words
The test strip according to claim 1 wherein said chromatographic solvent transport pathways are separated by means of solvent impermeable barriers.
Claim 10
Dependent Claim
17 words
The test strips according to claim 8 wherein said solvent impermeable barriers are formed by laser etching.
Claim 11
Dependent Claim
16 words
The test strips according to claim 1 wherein said chromatographic material is thin layer chromatographic material.
Claim 12
Dependent Claim
15 words
The test strips according to claim 10 wherein said thin layer chromatographic material is nitrocellulose.
Claim 13
Dependent Claim
13 words
The test strips according to claim 1 wherein said analyte is an antibody.
Claim 14
Dependent Claim
13 words
The test strips according to claim 1 wherein said analyte is an antigen.
Claim 15
Dependent Claim
13 words
The test strips according to claim 1 wherein said analyte is a polynucleotide.
Claim 16
Independent Claim
346 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 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 chromatographic solvent transport pathways; 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 a specific binding reaction with said analyte, a second zone for receiving said sample, and a third zone, downstream of said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for directing said first reagent at said third zone, said method comprising: (1) disposing said sample in said second zone; (2) dipping said first end into chromatographic solvent for a time sufficient to chromatographically transport said analyte and said first reagent to said third zone, wherein the relative mobility of said sample components and said first reagent is controlled by said plurality of chromatographic solvent transport pathways such that the analyte is transported to 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 the chromatographic solvent transport prior to the first reagent reaching said third zone; and (3) detecting the presence of said first reagent in said third zone as a measures of the analyte.
Claim 17
Independent Claim
346 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 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 chromatographic solvent transport pathways; 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 a specific binding reaction with said analyte, a second zone for receiving said sample, and a third zone, downstream of said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for directing said first reagent at said third zone, said method comprising: (1) disposing said sample in said second zone; (2) dipping said first end into chromatographic solvent for a time sufficient to chromatographically transport said analyte and said first reagent to said third zone, wherein the relative mobility of said sample components and said first reagent is controlled by said plurality of chromatographic solvent transport pathways such that the analyte is transported to 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 the chromatographic solvent transport prior to the first reagent reaching said third zone; and (3) detecting the presence of said first reagent in said third zone as a measures of the analyte.
Claim 18
Dependent Claim
25 words
A method according to claim 15 wherein said means for detecting said first reagent at said third zone is a label on said first reagent.
Claim 19
Dependent Claim
27 words
A method according to claim 15 wherein said means for detecting said first reagent at said third zone is a third reagent reactive with said first reagent.
Claim 20
Dependent Claim
14 words
A method according to claim 17 wherein the third reagent is an indicator substance.
Claim 21
Dependent Claim
34 words
A method according to claim 17 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 22
Dependent Claim
24 words
A method according to claim 19 wherein said first reagent and said third reagent are transported along pathways of travel which are partially noncoincident.
Claim 23
Dependent Claim
23 words
A method according to claim 19 wherein said sample and said third reagent are transported along pathways of travel which are partially non-coincident.
Claim 24
Dependent Claim
21 words
A method according to claim 15 wherein said chromatographic solvent pathways are partially noncoincident as a result of solvent impermeable barriers.
Claim 25
Dependent Claim
15 words
A method according to claim 15 wherein said chromatographic material is thin layer chromatographic material.
Claim 26
Dependent Claim
14 words
A method according to claim 23 wherein said thin layer chromatographic material is nitrocellulose.
Claim 27
Dependent Claim
25 words
A method according to claim 24 wherein said nitrocellulose is characterized by an average pore size ranging from about 0.1 micron to about 1 micron.
Claim 28
Dependent Claim
12 words
A method according to claim 15 wherein said analyte is an antibody.
Claim 29
Dependent Claim
12 words
A method according to claim 15 wherein said analyte is an antigen.
Claim 30
Dependent Claim
12 words
A method according to claim 15 wherein said analyte is a polynucleotide.
Claim 31
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 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 a specific binding reaction with an analyte, a second zone for receiving said sample, and a third zone, coincident with said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for detecting said first reagent at said third zone as a measure of the analyte, 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 first reagent to said third zone, whereby after said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent is such that the analyte is 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 the first reagent reaching said third zone, and (3) detecting the presence of said first reagent in said third zone as a measure of the analyte.
Claim 32
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 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 a specific binding reaction with an analyte, a second zone for receiving said sample, and a third zone, coincident with said second zone, impregnated with a second reagent which is immobilized against solvent transport and is capable of a specific binding reaction with the analyte so as to immobilize the analyte in 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, and means for detecting said first reagent at said third zone as a measure of the analyte, 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 first reagent to said third zone, whereby after said first end is dipped into said chromatographic solvent, the relative mobility of said sample components and said first reagent is such that the analyte is 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 the first reagent reaching said third zone, and (3) detecting the presence of said first reagent in said third zone as a measure of the analyte.
Claim 33
Dependent Claim
27 words
A method according to claim 29 wherein said means for detecting said first reagent at said third zone comprises a third reagent reactive with said first reagent.
Claim 34
Dependent Claim
34 words
A method according to claim 30 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 35
Dependent Claim
24 words
A method according to claim 31 wherein said first reagent and said third reagent are transported along pathways of travel which are partially non-coincident.
Claim 36
Dependent Claim
14 words
A method according to claim 29 wherein said chromatographic material comprises thin layer nitrocellulose.
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