US4959305A
Expired / Lapsed
US
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Reversible immobilization of assay reagents in a multizone test device
Assignee: Bayer Corp
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Filing: 1988-10-31
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Granted: 1990-09-25
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Expires: 2008-10-31
Abstract
Abstract A multizone test device for the determination of analyte in a liquid test medium. The test device preferably comprises multilayers including a first layer comprising a solid, porous matrix incorporated with a reversibly immobilized first reagent and a second layer comprising a solid, porous matrix incorporated with a second reagent which interacts with the first reagent and analyte from the liquid test medium to provide a detectable signal. A reversible binding interaction between the first reagent and the matrix of the first layer prevents the first reagent from prematurely migrating into the second layer during manufacture of the device and prior to application of the liquid test medium to the test device. The reversible binding interaction is sufficiently disruptable by contact of the first layer with the liquid test medium to release and thereby render diffusible an analytically effective amount of the first reagent within the test device.
Inventors
- 👤 David L. Woodrum
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 06:06
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54391; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
230 words
A multizone test device for the immunoassay determination of an antigen or hapten analyte in a liquid test medium, comprising, in fluid flow contact, (a) a reagent zone comprising a solid, porous matrix and a labeled reagent reversibly immobilized therein by a binding interaction between the labeled reagent and the matrix that is sufficiently disruptable by contact of the matrix with a predetermined component of the test medium other than the analyte to release and thereby render diffusible an analytically effective amount of the labeled reagent independent of the presence or amount of analyte in the liquid test medium, the labeled reagent comprising one of the pair (i) the analyte or a binding analog thereof, and (ii) an antibody which binds the analyte labeled with a detectable chemical group, (b) a reaction zone comprising a solid, porous matrix incorporated with an immobilized form of the other of said pair which interacts with both of the analyte and the labeled reagent to bind and thereby immobilize labeled reagent while leaving an amount of the labeled reagent diffusible as a function of the amount of analyte in the liquid test medium, and (c) a detection zone comprising a solid, porous matrix for receiving labeled reagent which is free to diffuse thereinto from the reaction zone to provide a detectable signal related to the amount of analyte present in the liquid test medium.
Claim 2
Dependent Claim
230 words
A multizone test device for the immunoassay determination of an antigen or hapten analyte in a liquid test medium, comprising, in fluid flow contact, (a) a reagent zone comprising a solid, porous matrix and a labeled reagent reversibly immobilized therein by a binding interaction between the labeled reagent and the matrix that is sufficiently disruptable by contact of the matrix with a predetermined component of the test medium other than the analyte to release and thereby render diffusible an analytically effective amount of the labeled reagent independent of the presence or amount of analyte in the liquid test medium, the labeled reagent comprising one of the pair (i) the analyte or a binding analog thereof, and (ii) an antibody which binds the analyte labeled with a detectable chemical group, (b) a reaction zone comprising a solid, porous matrix incorporated with an immobilized form of the other of said pair which interacts with both of the analyte and the labeled reagent to bind and thereby immobilize labeled reagent while leaving an amount of the labeled reagent diffusible as a function of the amount of analyte in the liquid test medium, and (c) a detection zone comprising a solid, porous matrix for receiving labeled reagent which is free to diffuse thereinto from the reaction zone to provide a detectable signal related to the amount of analyte present in the liquid test medium.
Claim 3
Dependent Claim
35 words
The test device of claim 1 wherein the reversible binding interaction is an anionic binding interaction between the labeled reagent and the reagent zone matrix and wherein the liquid test medium comprises a salt solution.
Claim 4
Dependent Claim
16 words
The test device of claim 2 wherein the reagent layer matrix comprises an ion exchange material.
Claim 5
Dependent Claim
32 words
The test device of claim 3 wherein the ion exchange material is an anion exchange material selected from the group consisting of diethylaminoethyl cellulose, epichlorohydrin triethanolamine cellulose, triethylaminoethyl cellulose bromide and polyethyleneimine.
Claim 6
Dependent Claim
29 words
The test device of claim 3 wherein the ion exchange material is a cation exchange material selected from the group consisting of carboxymethyl cellulose, phosphate cellulose and dextran sulfate.
Claim 7
Dependent Claim
36 words
The test device of claim 1 wherein the reversible binding interaction is a reversible covalent binding interaction between the labeled reagent and the reagent zone matrix and wherein the liquid test medium comprises a reducing agent.
Claim 8
Dependent Claim
35 words
The test device of claim 1 wherein the reversible binding interaction is a hydrophobic binding interaction between the labeled reagent and the reagent zone matrix and wherein the liquid test medium comprises a non-ionic detergent.
Claim 9
Dependent Claim
36 words
The test device of claim 1 wherein the reversible binding interaction is a reversible biochemical binding affinity between the labeled reagent and the reagent zone matrix and wherein the liquid test medium comprises a competing ligand.
Claim 10
Dependent Claim
33 words
The test device of claim 1 wherein the liquid test medium comprises an undiluted biological fluid test sample capable of disrupting the binding interaction between the reagent zone matrix and the labeled reagent.
Claim 11
Dependent Claim
38 words
The test device of claim 1 wherein the liquid test medium comprises a mixture of a biological fluid test sample and a diluent capable of disrupting the binding interaction between the reagent zone matrix and the first reagent.
Claim 12
Dependent Claim
25 words
The test device of claim 1 wherein the biological liquid test medium is whole blood, blood serum, blood plasma, amniotic fluid, cerebrospinal fluid or urine.
Claim 13
Dependent Claim
28 words
The test device of claim 1 wherein the detectable chemical group of the labeled reagent is coupled to the analyte, binding analog, or antibody by a linking group.
Claim 14
Dependent Claim
32 words
The test device of claim 12 wherein the reversible binding interaction is between the matrix of the reagent zone and the detectable chemical group or the linking group of the labeled reagent.
Claim 15
Dependent Claim
26 words
The test device of claim 11 wherein the detectable chemical group in the labeled reagent possesses a physical property which is detectable in the detection zone.
Claim 16
Dependent Claim
17 words
The test device of claim 14 wherein the detectable chemical group is a fluorescer or a chromophore.
Claim 17
Dependent Claim
41 words
The test device of claim 1 wherein the detectable chemical group in the labeled reagent possesses a detectable chemical property and the detection zone is incorporated with a detectant composition which interacts with the chemical group to provide the detectable signal.
Claim 18
Dependent Claim
33 words
The test device of claim 16 wherein the detectable chemical group is (i) an enzyme or (ii) a substrate or cofactor for such enzyme, and wherein the detectant composition comprises the other thereof.
Claim 19
Dependent Claim
14 words
The test device of claim 17 wherein the substrate is chromogenic fluorogenic or chemiluminescent.
Claim 20
Dependent Claim
27 words
The test device of claim 1 wherein the reagent zone, reaction zone and detection zone are in the form of layers in fluid contact with one another.
Claim 21
Dependent Claim
27 words
The test device of claim 19 which additionally comprises a solid, nonporous support element situated on the opposite side of the detection layer from the reagent layer.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1993-09-24 | 1994-03-26 | 1994-09-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1997-09-24 | 1998-03-26 | 1998-09-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2001-09-24 | 2002-03-26 | 2002-09-25 | $7700.00 | Window Closed / Lapsed |