EP0335244A2
Expired / Lapsed
EP
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Solid-phase analytical device and method for using same
Assignee: Abbott Laboratories
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Filing: 1989-03-22
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Granted: —
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Expires: 2009-03-22
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
EP
Data Source
google_patents
Last Synchronized
2026-11-08 01:14
CPC Classifications
G; G01; G01N; G01N30/00; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; G01N33/523; G01N33/528; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54391; G01N33/569; G01N33/56911; G01N33/576; G01N33/5761; G01N33/5764; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S436/00; Y10S436/807; Y10S436/808
Claims Analysis
Total Claims: 9
Claim 1
Independent Claim
176 words
In a chromatographic test apparatus useful for determining the presence or amount of analyte in a fluid sample in a binding assay, the apparatus including: a porous substrate having a reaction site, a site for contacting a fluid sample, and means for transporting the sample by capillarity or wicking to the reaction site; and label means for detecting a result, the improvement comprising: the reaction site having a positive control area containing immobilized binding reagent for label regardless of the presence of analyte in the sample, an analyte binding area containing immobilized binding reagent for analyte, and a negative control area; wherein the positive control area and the analyte binding area are shaped such that, taken together in the presence of label, they form a first known symbol representing a positive result in the presence of analyte in the sample; and wherein the positive control area is shaped such that, taken alone in the presence of label, it forms a second known symbol representing a negative result regardless of the presence of analyte in the sample.
Claim 2
Dependent Claim
176 words
In a chromatographic test apparatus useful for determining the presence or amount of analyte in a fluid sample in a binding assay, the apparatus including: a porous substrate having a reaction site, a site for contacting a fluid sample, and means for transporting the sample by capillarity or wicking to the reaction site; and label means for detecting a result, the improvement comprising: the reaction site having a positive control area containing immobilized binding reagent for label regardless of the presence of analyte in the sample, an analyte binding area containing immobilized binding reagent for analyte, and a negative control area; wherein the positive control area and the analyte binding area are shaped such that, taken together in the presence of label, they form a first known symbol representing a positive result in the presence of analyte in the sample; and wherein the positive control area is shaped such that, taken alone in the presence of label, it forms a second known symbol representing a negative result regardless of the presence of analyte in the sample.
Claim 3
Dependent Claim
23 words
The chromatographic device according to Claim 1 wherein neither the first nor the second symbol is formed if the test is performed improperly.
Claim 4
Dependent Claim
32 words
The chromatographic device according to Claim 1 wherein the positive control area is shaped as a rectangular bar to form a minus sign as the second symbol representative of a negative result.
Claim 5
Dependent Claim
38 words
The chromatographic device according to Claim 3 wherein the analyte binding area is shaped as two colinear rectangular half bars, the two half bars being oriented on either side of and substantially orthogonal to the positive control bar.
Claim 6
Dependent Claim
37 words
The chromatographic device according to Claim 4 wherein the two colinear half bars appear to intersect the positive control bar near its mid-point to form a plus sign as the first symbol representative of a positive result.
Claim 7
Dependent Claim
21 words
6 The chromatographic device according to Claim 1 wherein the label comprises a conjugate of anti-analyte antibody and a detectable moiety.
Claim 8
Dependent Claim
33 words
The chromatographic test device according to Claim 6 wherein the immobilized binding reagent for label comprises an immobilized antibody-analyte complex, the analyte having at beast one remaining determinant to which the conjugate binds.
Claim 9
Dependent Claim
35 words
The chromatographic test device according to Claim 1 wherein the sample fluid transported through the device contacts the positive control area, the negative control area and the analyte binding area at substantially the same time.
References Cited (Backward Citations)
No citation records indexed.
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