US5356782A
Expired / Lapsed
US
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Analytical test apparatus with on board negative and positive control
Assignee: Roche Diagnostics Operations Inc
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Filing: 1992-09-03
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Granted: 1994-10-18
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Expires: 2012-09-03
Abstract
Abstract The invention is an apparatus useful in carrying out an analytical assay. The apparatus has a positive and negative control, as well as a site for determining the presence, amount, or lack of an analyte in a sample.
Inventors
- 👤 David R. Moorman
- 👤 David J. Ledden
- 👤 David D. Webster
- 👤 Brian A. Heald
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 07:55
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/967; Y10S435/97; Y10S435/975
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
134 words
An apparatus for determining an analyte of interest in a liquid sample comprising an absorptive material and having a plurality of zones in the direction of fluid flow, wherein: (i) a first negative control zone of said absorptive material contains an immobilized reactant which does not bind to said analyte of interest; (ii) a second analytical zone of said absorptive material contains an immobilized reactant which specifically binds to said analyte of interest; and (iii) a third positive control zone of said absorptive material contains both (a) an immobilized reactant which specifically binds to said analyte of interest, and (b) a portion of the analyte of interest in solubilizible form, wherein said portion of the analyte is solubilized when contacted with the liquid sample and reacts with the immobilized reactant of said third zone.
Claim 2
Independent Claim
134 words
An apparatus for determining an analyte of interest in a liquid sample comprising an absorptive material and having a plurality of zones in the direction of fluid flow, wherein: (i) a first negative control zone of said absorptive material contains an immobilized reactant which does not bind to said analyte of interest; (ii) a second analytical zone of said absorptive material contains an immobilized reactant which specifically binds to said analyte of interest; and (iii) a third positive control zone of said absorptive material contains both (a) an immobilized reactant which specifically binds to said analyte of interest, and (b) a portion of the analyte of interest in solubilizible form, wherein said portion of the analyte is solubilized when contacted with the liquid sample and reacts with the immobilized reactant of said third zone.
Claim 3
Dependent Claim
21 words
The apparatus of claim 1, wherein the immobilized reactant of said second zone is an immobilized antibody or an antibody fragment.
Claim 4
Dependent Claim
21 words
The apparatus of claim 1, wherein said immobilized reactant is bound to a carrier which is immobilized in said second zone.
Claim 5
Dependent Claim
26 words
The apparatus of claim 3, wherein said carrier comprises a material selected from the group consisting of latex, glass, sepharose, agarose, polystyrene, mica and diatomaceous earth.
Claim 6
Dependent Claim
11 words
The apparatus of claim 3, wherein said carrier is a bead.
Claim 7
Dependent Claim
18 words
The apparatus of claim 5, wherein said carrier has a diameter of from 1.0 nm to 20 μm.
Claim 8
Dependent Claim
17 words
The apparatus of claim 6, wherein said carrier has a diameter of from 0.3 to 1.0 μm.
Claim 9
Dependent Claim
17 words
The apparatus of claim 7, wherein said carrier has a diameter of from 0.4 to 0.5 μm.
Claim 10
Dependent Claim
30 words
The apparatus of claim 1, wherein the immobilized reactant of said second zone is selected from the group consisting of an antigen and an epitope containing fragment of an antigen.
Claim 11
Dependent Claim
29 words
The apparatus of claim 1, wherein said second zone contains at least one substance selected from the group consisting of protein A, protein G, streptavidin, avidin, and a lectin.
Claim 12
Dependent Claim
19 words
The apparatus of claim 1, wherein the immobilized reactants of said second zone and said third zone are identical.
Claim 13
Dependent Claim
54 words
The apparatus of claim 1, wherein the immobilized reactant of said third zone and the immobilized reactant of said second zone are identical, and the immobilized reactant of said first zone is an inactive form of the immobilized reactants of said second and third zones, wherein said inactive form cannot specifically bind the analyte.
Claim 14
Dependent Claim
28 words
The apparatus of claim 1, wherein said immobilized reactant in said second zone is in a position perpendicular to the direction of fluid flow in said absorptive material.
Claim 15
Dependent Claim
29 words
The apparatus of claim 1, wherein said immobilized reactant in said third zone is in a position perpendicular to the direction of the fluid flow in said absorptive material.
Claim 16
Dependent Claim
21 words
The apparatus of claim 1, further comprising an additional zone positioned downstream of said third zone for absorption of excess fluid.
Claim 17
Dependent Claim
21 words
The apparatus of claim 15, wherein said additional zone contains a reagent which changes color in the presence of a fluid.
Claim 18
Dependent Claim
21 words
The apparatus of claim 15, wherein said additional zone contains a reagent which changes color when subjected to a pH change.
Claim 19
Dependent Claim
18 words
The apparatus of claim 15, wherein said additional zone contains a reagent which inhibits formation of detectable signal.
Claim 20
Dependent Claim
32 words
A kit for determining an analyte in a sample comprising the apparatus of claim 1 and a separate portion of a second, labeled receptor which specifically binds to said analyte of interest.
Claim 21
Dependent Claim
36 words
The kit of claim 19, wherein said labeled receptor is labeled with a label selected from the group consisting of an enzyme, gold, a dye sol, a colored particle, a fluorescer, a chemiluminescer, and a radiolabel.
Claim 22
Dependent Claim
24 words
The kit of claim 19, further comprising a separate portion of a substance which reacts with said labeled receptor to form a detectable signal.
Claim 23
Dependent Claim
15 words
The kit of claim 19, further comprising a separate portion of an inert run buffer.
Claim 24
Dependent Claim
13 words
The kit of claim 19, wherein said second, labeled receptor is an antibody.
Claim 25
Dependent Claim
61 words
The apparatus of claim 1, further comprising a further zone positioned upstream of said first zone, said further zone containing a substance which reacts with a labeled receptor to provide a detectable signal, and an absorptive means positioned on top of said further zone and in fluid contact therewith, wherein said further zone is in fluid contact with said first zone.
Claim 26
Dependent Claim
40 words
The apparatus of claim 24, further comprising a fluid flow inhibition means positioned so as to prevent fluid flow from said absorptive means into said first zone and to direct fluid flow from said absorptive means into said further zone.
Claim 27
Dependent Claim
31 words
The apparatus of claim 25, further comprising a second fluid flow inhibition means positioned between said further and first zones and extending along all of a region of fluid contact therebetween.
Claim 28
Dependent Claim
24 words
The apparatus of claim 24, further comprising a fluid flow regulating means positioned between said further and first zones which directs fluid flow vertically.
Claim 29
Dependent Claim
20 words
The apparatus of claim 1, further comprising an inert support on which said first, second and third zones are positioned.
Claim 30
Dependent Claim
18 words
The apparatus of claim 1, wherein the immobilized reactant of said second zone is an immobilized antibody fragment.
Claim 31
Dependent Claim
14 words
The kit of claim 19 wherein said second, labelled receptor is an antibody fragment.
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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) | 1997-10-17 | 1998-04-18 | 1998-10-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-10-17 | 2002-04-18 | 2002-10-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-10-17 | 2006-04-18 | 2006-10-18 | $7700.00 | Window Closed / Lapsed |