US4803170A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Competitive immunoassay method, device and test kit
Assignee: BTG International Inc
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Filing: 1986-12-24
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Granted: 1989-02-07
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Expires: 2006-12-24
Abstract
Abstract An immunoassay device including one or more reaction chambers, each adapted to receive and retain a volume of test fluid in fluid communication with nonoverlapping first, second, and third reagent-bearing surfaces. To the first surface is reversibly bound an analyte conjugate: analyte component conjugated to one or more components, termed ligand/marker, that serve ligand and marker functions as described herein. Analyte binding partner is immobilized on the second surface, and ligand/marker binding partner is immobilized on the third surface. The reaction chamber is preferably configured to receive and direct the test fluid sequentially past the first second, and third reagent surfaces. In use, analyte conjugate solubilized from the first surface completes with any analyte in the test fluid for analyte binding partner sites on the second surface. Excess analyte conjugate becomes sequestered on the third surface, where the marker activity is read to indicate analyte presence and concentration in the test fluid. A test kit includes the immunoassay device in combination with comparative test results.
Inventors
- 👤 Thomas H. Stanton
- 👤 James A. Clagett
- 👤 Deborah C. Schindele
- 👤 George E. Renzoni
- 👤 Niels H. Andersen
- 👤 Kent E. Opheim
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 04:34
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54306; G01N33/531; G01N33/532; G01N33/533; Y; Y10; Y10S; Y10S436/00; Y10S436/807; Y10S436/808; Y10S436/809
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
105 words
A device for detecting an analyte in a test fluid, comprising a reaction chamber having reagent, reaction, and detection surfaces wherein at least the detection surface does not overlap either the reagent surface or the reaction surface, the reaction chamber being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon.
Claim 2
Independent Claim
105 words
A device for detecting an analyte in a test fluid, comprising a reaction chamber having reagent, reaction, and detection surfaces wherein at least the detection surface does not overlap either the reagent surface or the reaction surface, the reaction chamber being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon.
Claim 3
Dependent Claim
16 words
The device of claim 1 wherein the analyte binding partner comprises an antibody, antigen, or hapten.
Claim 4
Dependent Claim
14 words
The device of claim 1 wherein the ligand/marker binding partner comprises avidin or biotin.
Claim 5
Dependent Claim
18 words
The device of claim 1 wherein the analyte binding partner and the ligand/marker binding partner comprise different antibodies.
Claim 6
Dependent Claim
26 words
The device of claim 1 wherein the reaction chamber is adapted to receive and direct the test fluid sequentially past the reagent, reaction, and detection surfaces.
Claim 7
Dependent Claim
19 words
The device of claim 5 wherein at least one of said reagent and reaction surfaces comprises a microporous membrane.
Claim 8
Dependent Claim
25 words
The device of claim 5 wherein the predetermined test fluid volume capacity of the reaction chamber is on the order of 10 to 100 μl.
Claim 9
Dependent Claim
19 words
The device of claim 5 wherein the reaction chamber further comprises wick means disposed downstream of the detection surface.
Claim 10
Dependent Claim
28 words
The device of claim 8 wherein the reaction chamber further comprises valve means for releasing from the reaction chamber air displaced by the received volume of test fluid.
Claim 11
Dependent Claim
16 words
The device of claim 5 wherein the reaction chamber is detachably mounted on an insoluble support.
Claim 12
Dependent Claim
15 words
The device of claim 5 wherein the detection surface is affixed to an insoluble support.
Claim 13
Dependent Claim
23 words
The device of claim 11 wherein the insoluble support comprises an aperture or window exposing the detection surface to visual or instrumental inspection.
Claim 14
Dependent Claim
32 words
The device of claim 5 wherein a plurality of said reaction chambers are detachably mounted on an insoluble support, the reaction chambers having identical ligand/marker binding partners but different analyte binding partners.
Claim 15
Dependent Claim
25 words
The device of claim 1 wherein the predetermined test fluid volume capacity of the reaction chamber is on the order of 100 to 200 μl.
Claim 16
Dependent Claim
13 words
The device of claim 14 wherein said reaction chamber comprises a microtiter well.
Claim 17
Dependent Claim
13 words
The device of claim 1 wherein said reaction chamber comprises a test tube.
Claim 18
Dependent Claim
19 words
The device of claim 1 wherein said analyte conjugate comprises a metallophthalocyanine selected from copper, silicon, and aluminum phthalocyanines.
Claim 19
Dependent Claim
13 words
The device of claim 17 wherein said phthalocyanine is in a monomeric form.
Claim 20
Dependent Claim
14 words
The device of claim 1 wherein said analyte conjugate comprises a luminescent metalloporphyrin derivative.
Claim 21
Dependent Claim
17 words
The device of claim 19 wherein said luminescent metalloporphyrin derivative is selected from ytterbium and platinum porphyrins.
Claim 22
Independent Claim
211 words
A method of detecting an analyte in a test fluid, comprising the steps of: providing a reaction chamber having reagent, reaction, and detection surfaces wherein at least the detection surface does not overlap either the reagent surface or the reaction surface, the reaction chamber being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon; introducing a volume of test fluid suspected of containing analyte into the reaction chamber in fluid communication with the reagent, reaction, and detection surfaces; retaining the volume of test fluid in the reaction chamber to permit solubilization of analyte conjugate from the reagent surface, binding of analyte and solubilized analyte conjugate to analyte binding partner on the reaction surface, and binding of solubilized analyte conjugate to ligand/marker binding partner on the detection surface; and, thereafter measuring the activity of sequestered ligand/marker on the detection surface, the measured activity being a function of the analyte concentration that is referable to standards and controls.
Claim 23
Independent Claim
211 words
A method of detecting an analyte in a test fluid, comprising the steps of: providing a reaction chamber having reagent, reaction, and detection surfaces wherein at least the detection surface does not overlap either the reagent surface or the reaction surface, the reaction chamber being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon; introducing a volume of test fluid suspected of containing analyte into the reaction chamber in fluid communication with the reagent, reaction, and detection surfaces; retaining the volume of test fluid in the reaction chamber to permit solubilization of analyte conjugate from the reagent surface, binding of analyte and solubilized analyte conjugate to analyte binding partner on the reaction surface, and binding of solubilized analyte conjugate to ligand/marker binding partner on the detection surface; and, thereafter measuring the activity of sequestered ligand/marker on the detection surface, the measured activity being a function of the analyte concentration that is referable to standards and controls.
Claim 24
Dependent Claim
26 words
The method of claim 21 wherein the reaction chamber is adapted to receive and direct the test fluid sequentially past the reagent, reaction, and detection surfaces.
Claim 25
Dependent Claim
13 words
The method of claim 21 wherein the reaction chamber comprises a microtiter well.
Claim 26
Dependent Claim
31 words
A test kit comprising the device of claim 1 in combination with comparative test results that associate ligand/marker activity on the detection surface with specific concentrations of analyte in test fluid.
Claim 27
Dependent Claim
15 words
The test kit of claim 24 wherein the comparative test results comprise a color chart.
Claim 28
Dependent Claim
31 words
A test kit comprising the device of claim 5 in combination with comparative test results that associate ligand/marker activity on the detection surface with specific concentrations of analyte in test fluid.
Claim 29
Independent Claim
89 words
A device for detecting an analyte in a test fluid, comprising a microtiter well having nonoverlapping reagent, reaction, and detection surfaces, the microtiter well being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon.
Claim 30
Independent Claim
89 words
A device for detecting an analyte in a test fluid, comprising a microtiter well having nonoverlapping reagent, reaction, and detection surfaces, the microtiter well being adapted to receive and retain a predetermined volume of the test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a ligand/marker binding partner immobilized thereon.
Claim 31
Dependent Claim
25 words
The device of claim 27, wherein the predetermined test fluid volume capacity of the microtiter well is on the order of 100 to 200 μl.
Claim 32
Independent Claim
196 words
A method of detecting an analyte in a test fluid, comprising the steps of: providing at least one microtiter well having nonoverlapping reagent, reaction, and detection surfaces, the microtiter well being adapted to receive and retain a predetermined volume of test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a iigand/marker binding partner immobilized thereon; introducing a volume of test fluid suspected of containing analyte into the reaction chamber in fluid communication with the reagent, reaction, and detection surfaces; retaining the volume of test fluid in the reaction chamber to permit solubilization of analyte conjugate from the reagent surface, binding of analyte and solubilized analyte conjugate to analyte binding partner on the reaction surface, and binding of solubilized analyte conjugate to ligand/marker binding partner on the detection surface; and, thereafter measuring the activity of sequestered ligand/marker on the detection surface, the measured activity being a function of the analyte concentration that is referable to standards and controls.
Claim 33
Independent Claim
196 words
A method of detecting an analyte in a test fluid, comprising the steps of: providing at least one microtiter well having nonoverlapping reagent, reaction, and detection surfaces, the microtiter well being adapted to receive and retain a predetermined volume of test fluid in fluid communication with said reagent, reaction, and detection surfaces, the reagent surface having an analyte conjugate reversibly bound thereto, the analyte conjugate comprising a ligand/marker conjugated to an analyte component, the reaction surface having an analyte binding partner immobilized thereon, and the detection surface having a iigand/marker binding partner immobilized thereon; introducing a volume of test fluid suspected of containing analyte into the reaction chamber in fluid communication with the reagent, reaction, and detection surfaces; retaining the volume of test fluid in the reaction chamber to permit solubilization of analyte conjugate from the reagent surface, binding of analyte and solubilized analyte conjugate to analyte binding partner on the reaction surface, and binding of solubilized analyte conjugate to ligand/marker binding partner on the detection surface; and, thereafter measuring the activity of sequestered ligand/marker on the detection surface, the measured activity being a function of the analyte concentration that is referable to standards and controls.
Claim 34
Dependent Claim
25 words
The method of claim 29, wherein the predetermined test fluid volume capacity of the microtiter well is on the order of 100 to 200 μl.
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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) | 1992-02-07 | 1992-08-08 | 1993-02-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-02-07 | 1996-08-08 | 1997-02-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-02-07 | 2000-08-08 | 2001-02-07 | $7700.00 | Window Closed / Lapsed |