Test device and method for colored particle immunoassay
DCFirst Claim
1. A method of detecting a ligand in a liquid sample suspected of containing said ligand, the method comprising the steps of:
- (a) providing a test strip, disposed within a housing, comprising sorbent material and defining a flow path, a sample inlet and, spaced apart from said inlet in said flow path,a test site having immobilized thereon a first protein having a binding site specific for a first epitope on said ligand and a separate control site;
(b) providing a conjugate comprising colored particulate material coupled to a second protein having a binding site specific for a second epitope on said ligand;
(c) applying to said inlet said liquid sample;
(d) transporting to said test site and said control site by sorption, capillary action, wicking, or wetting along said flow path said liquid sample in admixture with said conjugatethereby to produce,at said control site, color indicative of a valid test result and indicative that conjugate has bound specifically or non-specifically at said control site, andat said test site, of said ligand is present in said liquid sample, a specific binding reaction product comprising said ligand and an aggregate of said colored particulate material to produce a color visible to the unaided eye indicative of the presence of said ligand.
3 Assignments
Litigations
0 Petitions
Accused Products
Abstract
Disclosed is a test cell and a method for detection of a preselected ligand in a liquid sample such as a body fluid. The test cell includes an elongate outer casing which houses an interior permeable material capable of transporting an aqueous solution and defining a sample inlet, a test volume, and a reservoir volume. The reservoir volume is disposed in a section of the test cell spaced apart from the inlet and is filled with sorbent material. The reservoir acts to receive liquid transported along a flow path defined by the permeable material and extending from the inlet and through the test volume. In the test volume is a test site which includes a first protein having a binding site specific to a first epitope of the ligand immobilized in fluid communication with the flow path. The test site can be observed through a window of the casing.
-
Citations
10 Claims
-
1. A method of detecting a ligand in a liquid sample suspected of containing said ligand, the method comprising the steps of:
-
(a) providing a test strip, disposed within a housing, comprising sorbent material and defining a flow path, a sample inlet and, spaced apart from said inlet in said flow path, a test site having immobilized thereon a first protein having a binding site specific for a first epitope on said ligand and a separate control site; (b) providing a conjugate comprising colored particulate material coupled to a second protein having a binding site specific for a second epitope on said ligand; (c) applying to said inlet said liquid sample; (d) transporting to said test site and said control site by sorption, capillary action, wicking, or wetting along said flow path said liquid sample in admixture with said conjugate thereby to produce, at said control site, color indicative of a valid test result and indicative that conjugate has bound specifically or non-specifically at said control site, and at said test site, of said ligand is present in said liquid sample, a specific binding reaction product comprising said ligand and an aggregate of said colored particulate material to produce a color visible to the unaided eye indicative of the presence of said ligand. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
-
-
9. A method of detecting a ligand in a liquid sample suspected of containing said ligand, the method comprising the steps of:
-
(a) providing a test strip, disposed within a housing, comprising sorbent material and defining a flow path, a sample inlet, and, spaced apart from said inlet in said flow path, a test site having immobilized thereon a first protein having a binding site specific for a first epitope on said ligand, and a separate control site; (b) providing a conjugate comprising a metal sol particle coupled to a second protein having a binding site specific for a second epitope on said ligand; (c) applying to said inlet said liquid sample; and (d) transporting to said test site and said control site by sorption, capillary action, wicking or wetting along said flow path said liquid sample in admixture with said conjugate, thereby to produce, at said control site, color indicative of a valid test result and indicative that conjugate has bound specifically or non-specifically at said control site, and at said test site, if said ligand is present in said liquid sample, a specific binding reaction product comprising said ligand and an aggregate of said metal sol particle to produce a color visible to the unaided eye indicative of the presence of said ligand.
-
-
10. A method of detecting a ligand in a liquid sample suspected of containing said ligand, the method comprising the steps of:
-
(a) providing a test strip, disposed within a housing, comprising sorbent material and defining a flow path, a sample inlet, and, spaced apart from said inlet in said flow path, a test site having immobilized thereon a first protein having a binding site specific for a first epitope on said ligand, a separate control site, and disposed in said flow path upstream of said test site, a dried reagent consisting essentional of a conjugate comprising colored particulate material coupled to a second protein having a binding site specific for a second epitope on said ligand; (b) applying to said inlet said liquid sample; and (c) transporting by sorption, capillary action, wicking or wetting along said flow path said liquid sample into contact with said dried conjugate to produce an admixture of said liquid sample and said conjugate, and thereafter transporting said admixture into contact with said test site and said control site thereby to produce, at said control site, color indicative of a valid test result and indicative that conjugate has bound specifically or non-specifically at said control site, and at said test site, if said ligand is present in said liquid sample, a specific binding reaction product comprising said ligand and an aggregate of said colored particulate material to produce a color visible to the unaided eye indicative of the presence of said ligand.
-
Specification