Abstract An article for use in an assay for an analyte, comprising a solid support having at least a first portion and a second portion, the first and second portions being in capillary flow communication with each other whereby material may flow by capillarity from the first portion to the second portion and the second portion containing a binder immobilized wherein the binder being a binder for at least the analyte; a tracer comprised of a ligand portion and a detectable label portion conjugated to the ligand portion, the tracer being supported on the solid support on the first portion thereof, whereby when the first portion is wetted with a liquid sample suspected of containing analyte, tracer and any analyte flow by capillarity to the second portion for contact with the binder. A method of assay for an analyte comprises contacting a sample suspected of containing analyte to be assayed with the first portion of the above article; and determining at least one of tracer which is bound or not bound in the second portion.
An assay device for determining the presence or absence of an analyte in a liquid sample comprising: a) a test strip having at least a first and second portion and being arranged on the strip in the same plane in a manner such that material can flow from the first portion to the second portion; b) said first portion having a tracer movably supported therein wherein said tracer comprises a ligand, specific for the analyte when the device is configured for a sandwich assay and is the analyte or analogue thereof when the device is configured for a competitive assay, conjugated to a non-soluble particulate marker and being the site for addition of the sample; c) said second portion having immobilized therein a binder which is specific for the analyte when said device is configured for a sandwich assay and is specific for the analyte and ligand when said device is configured for a competitive assay; the binder being present in an amount such that tracer bound in such portion is visible.
Claim 2
Dependent Claim
172 words
An assay device for determining the presence or absence of an analyte in a liquid sample comprising: a) a test strip having at least a first and second portion and being arranged on the strip in the same plane in a manner such that material can flow from the first portion to the second portion; b) said first portion having a tracer movably supported therein wherein said tracer comprises a ligand, specific for the analyte when the device is configured for a sandwich assay and is the analyte or analogue thereof when the device is configured for a competitive assay, conjugated to a non-soluble particulate marker and being the site for addition of the sample; c) said second portion having immobilized therein a binder which is specific for the analyte when said device is configured for a sandwich assay and is specific for the analyte and ligand when said device is configured for a competitive assay; the binder being present in an amount such that tracer bound in such portion is visible.
Claim 3
Dependent Claim
20 words
A device as claimed in claim 1 wherein the detectable particulate marker is a coloured liposome or coloured polymeric bead.
Claim 4
Dependent Claim
16 words
A device as claimed in claim 2 wherein the particulate marker is a coloured polystyrene bead.
Claim 5
Independent Claim
22 words
A device as claimed in any one of claims 1-3 wherein the analyte is an antibody and the ligand is an antigen.
Claim 6
Independent Claim
24 words
A device as claimed in any one of claims 1 to 3 wherein the analyte is an antigen and the ligand is an antibody.
Claim 7
Independent Claim
31 words
A device as claimed in any one of the preceding claims which includes a third portion downstream of the second portion and being in capillary flow communication with said second portion.
Claim 8
Independent Claim
20 words
A device as claimed in anyone of the preceding claims wherein the second portion of said test strip comprises nitrocellulose.
Claim 9
Dependent Claim
93 words
A no-wash, one-step method for determining the presence or absence of an analyte in a liquid sample consisting of the steps of: a) adding a liquid sample to the first portion of the device as claimed in any one of the preceding claims; b) allowing sufficient time for the liquid to mix with the tracer and for the tracer-analyte mixture to flow to the second portion of the device of claim 1; and c) reading the result by detecting the presence or absence of the visible particulate detectable marker in the second portion.
References Cited (Backward Citations)
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