US5008080A
Expired / Lapsed
US
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Solid-phase analytical device and method for using same
Assignee: Alere Switzerland GmbH
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Filing: 1990-02-06
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Granted: 1991-04-16
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Expires: 2010-02-06
Abstract
Abstract A novel material and device useful in solid-phase binding assays to determine the presence or amount of an analyte in a test sample, particularly antigens, antibodies, or other ligands or DNA segments. The material and device comprises a reaction site having procedural controls and an analyte binding area capable of being simultaneously contacted by the sample and reagent used in the performance of the assay. The procedural controls and analyte binding areas operate to provide readable results as to the presence or absence of analyte and simultaneously verify the assay procedure and therefore the assay result.
Inventors
- 👤 William E. Brown, III
- 👤 Sarah E. Safford
- 👤 John M. Clemens
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-04 10:12
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/569; G01N33/56911; G01N33/52; G01N33/521; G01N33/523; G01N33/528; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54391; G01N33/576; G01N33/5761; G01N33/5764; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97; Y10S435/971
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
149 words
A solid phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample through the use of a label capable of producing a detectable response, said device comprising a reaction site having: a negative control area, a positive control area within said negative control area containing immobilized binding reagent for said label, and an analyte binding area within said negative control area containing immobilized binding reagent for analyte in the sample, said positive control area being shaped such that, in the presence or absence of analyte in the sample, a minus symbol is displayed representing a negative result of a valid assay, and said analyte binding area being shaped such that, taken together with said minus symbol in the presence of said label and analyte, a plus symbol is formed representing a positive result of a valid assay.
Claim 2
Dependent Claim
149 words
A solid phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample through the use of a label capable of producing a detectable response, said device comprising a reaction site having: a negative control area, a positive control area within said negative control area containing immobilized binding reagent for said label, and an analyte binding area within said negative control area containing immobilized binding reagent for analyte in the sample, said positive control area being shaped such that, in the presence or absence of analyte in the sample, a minus symbol is displayed representing a negative result of a valid assay, and said analyte binding area being shaped such that, taken together with said minus symbol in the presence of said label and analyte, a plus symbol is formed representing a positive result of a valid assay.
Claim 3
Dependent Claim
27 words
The assay device of claim 1 wherein said negative control area comprises an area free of any reagent capable of reacting with said analyte or said label.
Claim 4
Dependent Claim
26 words
The assay device of claim 1 wherein the validity of the assay is confirmed by a detectable response to said label in said positive control area.
Claim 5
Dependent Claim
17 words
The assay device of claim 3 wherein said detectable response is the formation of said minus symbol.
Claim 6
Dependent Claim
40 words
The assay device of claim 1 wherein the negative control area, the positive control area and the analyte binding area are substantially oriented in a single reaction area capable of being contacted with singly applied drops of sample or reagent.
Claim 7
Dependent Claim
28 words
The assay device of claim 1 wherein the analyte binding area comprises two rectangular bars on opposite sides of and oriented perpendicularly with respect to the minus symbol.
Claim 8
Dependent Claim
135 words
A solid phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample through the use of a label capable of producing a detectable response, said device comprising a reaction site having: a control area including means for displaying a minus symbol in the presence or absence of analyte, said minus symbol being capable of representing a negative result of a valid assay; and an analyte binding area including means for displaying a detectable response in the presence of analyte to represent the presence or amount of the analyte in the fluid sample, the detectable response being in the form of at least one bar which, taken together with the minus symbol, forms a plus symbol representing a positive result of a valid assay.
Claim 9
Dependent Claim
135 words
A solid phase assay device for use in a binding assay to determine the presence or amount of an analyte in a fluid sample through the use of a label capable of producing a detectable response, said device comprising a reaction site having: a control area including means for displaying a minus symbol in the presence or absence of analyte, said minus symbol being capable of representing a negative result of a valid assay; and an analyte binding area including means for displaying a detectable response in the presence of analyte to represent the presence or amount of the analyte in the fluid sample, the detectable response being in the form of at least one bar which, taken together with the minus symbol, forms a plus symbol representing a positive result of a valid assay.
Claim 10
Dependent Claim
25 words
The assay device of claim 7 wherein the validity of the assay is confirmed by a detectable response to said label in said control area.
Claim 11
Dependent Claim
17 words
The assay device of claim 8 wherein said detectable response is the formation of said minus symbol.
Claim 12
Dependent Claim
27 words
The assay device of claim 7 wherein the display of the minus symbol in the absence of said at least one bar represents a valid negative result.
Claim 13
Dependent Claim
35 words
The assay device of claim 7 wherein the control device and the analyte binding area are substantially oriented in a single reaction area capable of being contacted with singly applied drops of sample or reagent.
Claim 14
Dependent Claim
28 words
The assay device of claim 7 wherein the analyte binding area comprises two rectangular bars on opposite sides of and oriented perpendicularly with respect to the minus symbol.
References Cited (Backward Citations)
US3260413A
Cited
GB1420916A
Cited
US4099886A
Cited
US4059407A
Cited
US4246339A
Cited
US4477575A
Cited
US4477575B1
Cited
US4366241A
Cited
US4472353A
Cited
US4366241B1
Cited
US4540659A
Cited
EP0063810A1
Cited
WO1984004171A1
Cited
US4496654A
Cited
US4541987A
Cited
US4632901A
Cited
EP0171150B1
Cited
EP0177352A1
Cited
US4740468A
Cited
US4649121A
Cited
EP0200381A1
Cited
US4916056A
Cited
EP0249418A2
Cited
EP0260965A2
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-04-15 | 1994-10-15 | 1995-04-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-04-15 | 1998-10-15 | 1999-04-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-04-15 | 2002-10-15 | 2003-04-16 | $7700.00 | Window Closed / Lapsed |