US4703017A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Solid phase assay with visual readout
Assignee: Becton Dickinson and Co
•
Filing: 1984-02-14
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Granted: 1987-10-27
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Expires: 2004-02-14
Abstract
Abstract Solid phase assay for an analyte wherein binder is supported on a solid support, such as nitrocellulose, and the tracer is comprised of ligand labeled with a colored particulate label, such as a liposome including a dye. The assay has a high sensitivity, and the tracer is visible on the support under assay conditions, whereby tracer can be determined, without instrumentation, and without further treatment thereof.
Inventors
- 👤 Robert L. Campbell
- 👤 Daniel B. Wagner
- 👤 James P. O'Connell
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-31 13:18
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; B; B82; B82Y; B82Y5/00; G01N33/531; G01N33/532; Y; Y10; Y10S; Y10S436/00; Y10S436/80; Y10S436/807; Y10S436/808; Y10S436/809; Y10S436/815; Y10S436/817; Y10S436/818; Y10S436/829
Claims Analysis
Total Claims: 66
Claim 1
Independent Claim
176 words
A process for assaying for an analyte, comprising: contacting a binder supported on a test area of a solid with a solution of analyte and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visable dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound to one of the binder and analyte whereby the tracer is bound to one of the binder on the support and the analyte bound to the binder on the support, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby bound tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 ; and determining the visibility of tracer bound in said test area as a measure of analyte in a sample.
Claim 2
Dependent Claim
176 words
A process for assaying for an analyte, comprising: contacting a binder supported on a test area of a solid with a solution of analyte and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visable dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound to one of the binder and analyte whereby the tracer is bound to one of the binder on the support and the analyte bound to the binder on the support, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby bound tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 ; and determining the visibility of tracer bound in said test area as a measure of analyte in a sample.
Claim 3
Dependent Claim
19 words
The process of claim 1 wherein analyte and tracer are sequentially contacted with the binder on the solid support.
Claim 4
Dependent Claim
19 words
The process of claim 1 wherein the analyte and tracer are simultaneously contacted with binder on the solid support.
Claim 5
Dependent Claim
18 words
The process of claim 1 wherein the label of the tracer is a sac including a visible dye.
Claim 6
Dependent Claim
11 words
The process of claim 4 wherein the sac is a liposome.
Claim 7
Dependent Claim
19 words
The process of claim 5 wherein the visibility of the bound tracer is determined without lysis of the liposome.
Claim 8
Dependent Claim
13 words
The process of claim 1 wherein the solid support is in sheet form.
Claim 9
Dependent Claim
11 words
The process of claim 1 wherein the binder is an antibody.
Claim 10
Dependent Claim
15 words
The process of claim 8 wherein the tracer is a labeled form of the analyte.
Claim 11
Dependent Claim
18 words
The process of claim 8 wherein the tracer is a labeled form of an antibody for the analyte.
Claim 12
Dependent Claim
10 words
The process of claim 1 wherein the analyte is digoxin.
Claim 13
Dependent Claim
10 words
The process of claim 1 wherein the analyte is hCG.
Claim 14
Dependent Claim
13 words
The process of claim 1 wherein the particulate label is a colored particle.
Claim 15
Dependent Claim
158 words
A process for assaying for an analyte, comprising: contacting a binder supported on a test area of a solid support with a solution analyte and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound by one of the binder on the support and the analyte bound to the binder on the support, said test area being formed of nitrocellulose, said binder being supported in said test area in a concentration whereby bound tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 ; and determining the visibility of tracer bound in said test area as a measure of analyte in a sample.
Claim 16
Dependent Claim
158 words
A process for assaying for an analyte, comprising: contacting a binder supported on a test area of a solid support with a solution analyte and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound by one of the binder on the support and the analyte bound to the binder on the support, said test area being formed of nitrocellulose, said binder being supported in said test area in a concentration whereby bound tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 ; and determining the visibility of tracer bound in said test area as a measure of analyte in a sample.
Claim 17
Dependent Claim
17 words
The process of claim 14 wherein the visible particulate label is a sac including a visible dye.
Claim 18
Dependent Claim
11 words
The process of claim 15 wherein the sac is a liposome.
Claim 19
Dependent Claim
21 words
The process of claim 16 wherein the visibility of tracer in said test area is determined without lysis of the liposome.
Claim 20
Dependent Claim
10 words
The process of claim 17 wherein the analyte is hCG.
Claim 21
Dependent Claim
10 words
The process of claim 17 wherein the analyte is digoxin.
Claim 22
Dependent Claim
22 words
The process of claim 17 wherein the analyte is in a sample in a concentration of no greater than 10 -9 gm/ml.
Claim 23
Dependent Claim
22 words
The process of claim 14 wherein the analyte is in a sample in a concentration of no greater than 10 -9 gm/ml.
Claim 24
Dependent Claim
13 words
The process of claim 14 wherein the solid support is in sheet form.
Claim 25
Dependent Claim
15 words
The process of claim 14 wherein the support contains a plurality of said test areas.
Claim 26
Dependent Claim
13 words
The process of claim 14 wherein the particulate label is a colored particle.
Claim 27
Dependent Claim
13 words
The process of claim 14 wherein the particulate label is a hydrophobic dye.
Claim 28
Dependent Claim
20 words
The process of claim 14 wherein the binder is supported in a concentration of at least 40 μg/cm 2 .
Claim 29
Dependent Claim
25 words
The process of claim 26 wherein the binder is in the test area as a spot having a diameter of from 3 to 5 mm.
Claim 30
Dependent Claim
32 words
The process of claim 1 wherein the assay is for hCG, the binder is antibody to hCG and said tracer is comprised of antibody to hCG labeled with a colored particulate label.
Claim 31
Dependent Claim
13 words
The process of claim 28 wherein the test area is formed of nitrocellulose.
Claim 32
Dependent Claim
12 words
The process of claim 29 wherein the particulate label is a sac.
Claim 33
Dependent Claim
25 words
The process of claim 30 wherein the particulate label is a sac containing a visible dye and visibility is determined without lysis of the sac.
Claim 34
Dependent Claim
14 words
The process of claim 31 wherein the particulate label is a liposome containing rhodamine.
Claim 35
Dependent Claim
37 words
The process of claim 1 wherein the assay is for digoxin said binder is antibody to digoxin and the tracer is comprised of an analogue of digoxin bound by said antibody labeled with a colored particulate label.
Claim 36
Dependent Claim
13 words
The process of claim 33 wherein the test area is formed of nitrocellulose.
Claim 37
Dependent Claim
12 words
The process of claim 34 wherein the particulate label is a sac.
Claim 38
Dependent Claim
25 words
The process of claim 35 wherein the particulate label is a sac containing a visible dye and visibility is determined without lysis of the sac.
Claim 39
Dependent Claim
14 words
The process of claim 36 wherein the particulate label is a liposome containing rhodamine.
Claim 40
Dependent Claim
158 words
A reagent kit for determining an analyte in solution comprising: a solid support including a binder on a test area of the solid support in a concentration of at least 1 μg/cm 2 ; and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound to one of the binder on the support and the analyte bound to the binder on the support during an assay, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby bound tracer is visible on the support under assay condition, said binder being supported in a concentration of at least 1 μg/cm 2 .
Claim 41
Dependent Claim
158 words
A reagent kit for determining an analyte in solution comprising: a solid support including a binder on a test area of the solid support in a concentration of at least 1 μg/cm 2 ; and a tracer, said binder being a binder for at least the analyte, said tracer being comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye, said sac is selected from the group consisting of liposomes and microcapsules, said ligand being bound to one of the binder on the support and the analyte bound to the binder on the support during an assay, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby bound tracer is visible on the support under assay condition, said binder being supported in a concentration of at least 1 μg/cm 2 .
Claim 42
Dependent Claim
13 words
The kit of claim 38 wherein the test area is formed of nitrocellulose.
Claim 43
Dependent Claim
11 words
The kit of claim 39 wherein the binder is an antibody.
Claim 44
Dependent Claim
18 words
The kit of claim 40 wherein the label of the tracer is a lipsome including a visible dye.
Claim 45
Dependent Claim
10 words
The kit of claim 41 wherein the analyte is hCG.
Claim 46
Dependent Claim
22 words
The kit of claim 42 wherein the binder is antibody to hCG and the ligand of the tracer is antibody to hCG.
Claim 47
Dependent Claim
27 words
The kit of claim 41 wherein the analyte is digoxin, the binder is antibody to digoxin and the ligand of the tracer is an analogue of digoxin.
Claim 48
Dependent Claim
18 words
The kit of claim 39 wherein the label of the tracer is a liposome including a visible dye.
Claim 49
Dependent Claim
22 words
The process of claim 1 wherein the analyte is present in a concentration of no greater than 10 -9 grams per milliliter.
Claim 50
Dependent Claim
24 words
The process of claim 1 wherein said test area is capable of supporting binder in a concentration of at least ten micrograms per centimeter.
Claim 51
Dependent Claim
18 words
The process of claim 46 or 47 wherein the binder is in the test area as a spot.
Claim 52
Dependent Claim
24 words
The process of any one of claims 1, 46 or 48 wherein the particulate label is a precipitated or insoluble metal or metal alloy.
Claim 53
Dependent Claim
18 words
The process of claim 46 wherein the label of the tracer is a liposome including a visible dye.
Claim 54
Dependent Claim
20 words
The process of claim 14 or 21 wherein the particulate label is a precipitated or insoluble metal or metal alloy.
Claim 55
Dependent Claim
19 words
The kit of claim 38, 39 or 40 wherein the binder is in the test area as a spot.
Claim 56
Dependent Claim
21 words
The kit of claim 38, 39 or 40 wherein the particulate label is a precipitated or insoluble metal or metal alloy.
Claim 57
Dependent Claim
21 words
The process of claim 14 wherein the ligand is bound to the analyte whereby the tracer is bound to the analyte.
Claim 58
Dependent Claim
22 words
The process of claim 54 wherein ligand is directly bound to the analyte whereby the tracer is directly bound to the analyte.
Claim 59
Dependent Claim
21 words
The process of claim 1 wherein the ligand is bound to the analyte whereby the tracer is bound to the analyte.
Claim 60
Dependent Claim
22 words
The process of claim 56 wherein ligand is directly bound to the analyte whereby the tracer is directly bound to the analyte.
Claim 61
Dependent Claim
14 words
The process of claim 5 or 16 wherein the visible dye is sulforhodamine B.
Claim 62
Dependent Claim
138 words
A process for assaying for an analyte, comprising: contacting a binder for an analyte supported on a test area of a solid support with a solution of analyte to bind analyte to said binder; determining bound analyte by use of a tracer comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye said sac is selected from the group consisting of liposomes and microcapsules, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 , said analyte being determined by the visibility of the tracer in the test area.
Claim 63
Dependent Claim
138 words
A process for assaying for an analyte, comprising: contacting a binder for an analyte supported on a test area of a solid support with a solution of analyte to bind analyte to said binder; determining bound analyte by use of a tracer comprised of a ligand labeled with a visible particulate label wherein when said particulate label is a sac including a visible dye said sac is selected from the group consisting of liposomes and microcapsules, said test area being formed of a material having a surface area for supporting the binder and the binder being supported in a concentration whereby tracer is visible on the support under assay conditions, said binder being supported in a concentration of at least 1 μg/cm 2 , said analyte being determined by the visibility of the tracer in the test area.
Claim 64
Dependent Claim
13 words
The process of claim 59 wherein the test area is formed from nitrocellulose.
Claim 65
Dependent Claim
16 words
The process of claim 59 wherein the particulate label is a liposome including a visible dye.
Claim 66
Dependent Claim
24 words
The process of any one of claims 59, 60 or 61 wherein the binder is supported in a concentration of at least 10 ug/cm.
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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) | 1990-10-26 | 1991-04-27 | 1991-10-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-10-26 | 1995-04-27 | 1995-10-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-10-26 | 1999-04-27 | 1999-10-27 | $7700.00 | Window Closed / Lapsed |