Lateral flow chromatographic binding assay device
First Claim
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1. A test device for determining the presence or amount of an analyte substance in a sample by means of one or more specific binding reactions comprising:
- a chromatographic medium which extends throughout said device, defining a flowpath having capillarity and the capacity for chromatographic solvent transport of one or more reactive sample components and non-immobilized reagents;
said chromatographic medium comprising (1) a prefiltering zone;
(2) a reaction site disposed downstream from said prefiltering zone at which is present an immobilized reagent capable of binding a member from the group consisting of said analyte substance and a labelled specific binding material, and at which the presence or amount of immobilized labelled specific binding material may be detected; and
(3) a downstream zone free of said immobilized reagent disposed downstream from said reaction site,a sample application means selected from the group consisting of a well and an absorbant pad located adjacent to and disposed in fluid contact with said prefiltering zone of said chromatographic medium and offset upstream from said reaction site, anda liquid absorption means consisting of a quantity of blotter material disposed in fluid contact with said downstream zone of said chromatographic medium and offset downstream from said reaction site.
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Abstract
The present invention relates to improved specific binding assay devices comprising a chromatographic medium including a reaction site at which a specific binding reagent is immobilized, a sample application well located adjacent to the chromatographic medium and offset upstream from the reaction site, and a liquid absorption blotter offset downstream from the reaction site.
260 Citations
11 Claims
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1. A test device for determining the presence or amount of an analyte substance in a sample by means of one or more specific binding reactions comprising:
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a chromatographic medium which extends throughout said device, defining a flowpath having capillarity and the capacity for chromatographic solvent transport of one or more reactive sample components and non-immobilized reagents;
said chromatographic medium comprising (1) a prefiltering zone;
(2) a reaction site disposed downstream from said prefiltering zone at which is present an immobilized reagent capable of binding a member from the group consisting of said analyte substance and a labelled specific binding material, and at which the presence or amount of immobilized labelled specific binding material may be detected; and
(3) a downstream zone free of said immobilized reagent disposed downstream from said reaction site,a sample application means selected from the group consisting of a well and an absorbant pad located adjacent to and disposed in fluid contact with said prefiltering zone of said chromatographic medium and offset upstream from said reaction site, and a liquid absorption means consisting of a quantity of blotter material disposed in fluid contact with said downstream zone of said chromatographic medium and offset downstream from said reaction site. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for determining the presence or amount of an analyte substance in a sample which method utilizes a device comprising:
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a chromatographic medium which extends throughout said device, defining a flowpath having capillarity and the capacity for chromatogrpahic solvent transport of one or more non-immobilized reagents and reactive sample components, said chromatographic medium comprising (1) a prefiltering zone;
(2) a reaction site disposed downstream from said prefiltering zone at which is present an immobilized reagent capable of binding a member from the group consisting of said analyte substance and a labelled specific binding material, and at which the presence or amount of immobilized labelled specific binding material may be detected and (3) downstream zone free of said immobilized reagent disposed downstream from said reaction site,a sample application means selected from the group consisting of a well and an absorbant pad located adjacent to and disposed in fluid contact with said prefiltering zone of said chromatographic material and offset upstream from said reaction site, and a liquid absorption means consisting of a quantity of blotter disposed in fluid contact with said downstream zone of said chromatogrpahic medium and offset downstream from said reaction site, said method comprising; (a) applying a volume of said sample to said sample application means whereby said sample is transported onto said chromatographic medium at said prefiltering zone and along said chromatographic medium through said reaction site, and said downstream zone to said sample absorption means, (b) contacting said labelled specific binding material to said reaction site, and (c) determining the presence or amount of labelled specific binding material immobilized at said reaction site as an indication of the presence or amount of the analyte substance in the sample. - View Dependent Claims (8, 9, 10, 11)
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Specification