US5049358A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Composition and test device for assaying for proteins
Assignee: Bayer Corp
•
Filing: 1988-09-30
•
Granted: 1991-09-17
•
Expires: 2008-09-30
Abstract
Abstract A test device and method of determining the presence and concentration of proteins, such as albumin or Bence Jones proteins, in a test sample. The test device includes a carrier matrix incorporating a reactant system capable of interacting with proteins to produce a visually or instrumentally detectable and/or measurable response. The carrier matrix of the device can include commonly use bibulous matrices, such as filter paper, or a nonbibulous protein-permeable strip, membrane or layer of a polymerized urethane-containing composition. In addition, a reactant system, including a dual indicator reagent system, such as bromophenol blue, methyl orange and, if necessary, a suitable buffer, is incorporated into the carrier matrix to provide improved color resolution and increased sensitivity to proteins, thereby affording a more accurate and trustworthy protein assay of test samples, such as urine. Furthermore, by incorporating the dual indicator reagent system into a carrier matrix including a polymerized urethane-containing composition, a dry phase assay for low molecular weight proteins, such as Bence Jones proteins, can be performed on a liquid test sample.
Inventors
- 👤 Arthur L. Y. Lau
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 12:12
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/68; G01N33/6803; G01N33/6827; G01N33/6839; G01N33/52; G01N33/521; G01N33/523; G01N33/6854; G01N33/6857
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
171 words
A composition capable of exhibiting a sufficient color transition upon contacting a protein-containing liquid test sample to show the presence and/or concentration of protein in the liquid test sample comprising: a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs form the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indocator dye, wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes no not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
Claim 2
Dependent Claim
171 words
A composition capable of exhibiting a sufficient color transition upon contacting a protein-containing liquid test sample to show the presence and/or concentration of protein in the liquid test sample comprising: a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs form the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indocator dye, wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes no not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
Claim 3
Dependent Claim
24 words
The composition of claim 1 wherein the first indicator dye undergoes a color transition from a less intense color to a more intense color.
Claim 4
Dependent Claim
33 words
The composition of claim 1 wherein the weight ratio of the first indicator dye to the second indicator dye is in the range of approximately 5 to 1 to approximately 1 to 5.
Claim 5
Dependent Claim
33 words
The composition of claim 3 wherein the weight ratio of the first indicator dye to the second indicator dye is in the range of approximately 3 to 1 to approximately 1 to 3.
Claim 6
Dependent Claim
22 words
The composition of claim, wherein the first indicator dye and the second indicator dye exhibit a color transition at an acidic pH.
Claim 7
Dependent Claim
47 words
The composition of claim 5 wherein the acidic pH is maintained constant by adder buffer selected from the group consisting of citrate, malonate, lactate, trichloroacetate, sulfosalicylate, tartarate, phosphates, borates, acetates, piperazine-N,N'-bis(2-hydroxypropane)sulfonic acid (POPSO), N-2-hydroxythylpiperazine-N'-2-ethanesulfonic acid (HEPES), 3-N-(trishydroxymethyl)methylamino-2-hydroxypropanesulfonic acid (TAPSO), and 2-([atris-(hydroxymethyl)methyl] amino)ethanesulfonic acid (TES); or combinations thereof.
Claim 8
Dependent Claim
27 words
The composition of claim 5 wherein the first indicator dye and the second indicator dye exhibit a color transition at a pH of approximately 5 or less.
Claim 9
Dependent Claim
33 words
The composition of claim 7 wherein the color transition pH of the first indicator dye and the color transition pH of the second indicator dye differ by approximately 0.2 pH unit or less.
Claim 10
Dependent Claim
33 words
The composition of claim 1 wherein the color transition pH of the first indicator dye and the color transition pH of the second indicator dye differ by approximately 0.5 pH unit or less.
Claim 11
Dependent Claim
47 words
The composition of claim 1 wherein the first indicator dye and the second indicator dye are selected from the group consisting of bromochlorophenol blue, iodophenol blue, rose bengal, bromophenol blue, methyl orange, tetrabromophenol blue, bromopyrogallol red, bromocresol green, tetrabromophenolphthalein ethyl ester, bromophenol red, 8-amino-11-aza-6-thia-[5,12-naphthacenequinone] and bromocresol purple.
Claim 12
Dependent Claim
40 words
The composition of claim 1 wherein the first indicator dye is selected from the group consisting of bromochlorophenol blue, iodophenol blue, rose bengal, bromophenol blue, tetrabromophenol blue, bromopyrogallol red, bromocresol green, tetrabromophenolphthalein ethyl ester, bromophenol red, 8-amino-11-aza-6-thia-[5,12-naphthacenequinone] and bromocresol purple.
Claim 13
Dependent Claim
22 words
The composition of claim 1 wherein the second indicator dye is selected from the group consisting of methyl orange and bromophenol red.
Claim 14
Dependent Claim
34 words
The composition of claim 1, wherein the first indicator dye is selected from the group consisting of bromochlorophenol blue, bromophenol blue, tetrabromophenol blue, and iodophenol blue and the second indicator dye is methyl orange.
Claim 15
Dependent Claim
20 words
The composition of claim 1 wherein the first indicator dye is 8-amino-11-aza-6-thia-[5,12-naphthacenequinone], and the second indicator dye is bromophenol red.
Claim 16
Dependent Claim
21 words
The composition of claim 1 wherein the first indicator dye is bromocresol green and the second indicator dye is bromophenol red.
Claim 17
Dependent Claim
189 words
An analyte detection device for determining the presence and/or concentration of protein in a liquid test sample comprising: a support strip; a reagent test pad attached to said support strip; and a dual indicator reagent composition incorporated into the reagent test pad, said dual indicator reagent composition comprising: a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs from the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indicator dye, wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes do not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
Claim 18
Dependent Claim
189 words
An analyte detection device for determining the presence and/or concentration of protein in a liquid test sample comprising: a support strip; a reagent test pad attached to said support strip; and a dual indicator reagent composition incorporated into the reagent test pad, said dual indicator reagent composition comprising: a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs from the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indicator dye, wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes do not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
Claim 19
Dependent Claim
47 words
The analyte detection device of claim 16 to determine the presence and/or concentration of albumin in a liquid test sample wherein the reagent test pad comprises either a bibulous matrix or a nonbibulous matrix. the reagent test pad comprises either a bibulous matrix or a nonbibulous matrix.
Claim 20
Dependent Claim
26 words
The analyte detection device of claim 17 wherein the bibulous matrix is filter paper or the nonbibulous matrix is a polymerized urethane-based film, layer or membrane.
Claim 21
Dependent Claim
30 words
The analyte detection device of claim 16 for determining the presence and/or concentration of Bence Jones proteins in a liquid sample wherein the reagent test pad comprises a nonbibulous matrix.
Claim 22
Dependent Claim
19 words
The analyte detection device of claim 19 wherein the nonbibulous matrix is a polymerized urethane-based film, layer or membrane.
Claim 23
Dependent Claim
221 words
A test article for detecting the relative concentration of a protein i a test fluid comprising a matrix layer polymerized from a polymerizable urethane compound dispersed in a liquid vehicle and having homogeneously incorporated therein a dual indicator reagent composition capable of reaction with said protein of said test fluid, said reaction being one producing a detectable change in said matrix, and wherein (a) said matrix is permeable to said protein, and (b) the dual indicator reagent composition comprises a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs from the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indicator dye, and wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes do not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
Claim 24
Dependent Claim
221 words
A test article for detecting the relative concentration of a protein i a test fluid comprising a matrix layer polymerized from a polymerizable urethane compound dispersed in a liquid vehicle and having homogeneously incorporated therein a dual indicator reagent composition capable of reaction with said protein of said test fluid, said reaction being one producing a detectable change in said matrix, and wherein (a) said matrix is permeable to said protein, and (b) the dual indicator reagent composition comprises a first indicator dye capable of undergoing a detectable and measurable color transition from a first color to a second color; a second indicator dye capable of undergoing a detectable and measurable color transition at approximately the same pH as the first indicator dye to a color that differs from the second color of the first indicator dye; and a suitable buffer to maintain a constant pH sufficiently close to the color transition pH of the first indicator dye and the color transition pH of the second indicator dye, and wherein each dye is capable of preferentially interacting with protein in the test sample to undergo any said color transition, wherein any said color transitions of the dyes do not mutually interfere with each other, and wherein each of the dyes have approximately the same affinity for protein in the test sample.
References Cited (Backward Citations)
US2643230A
Cited
US3485587A
Cited
US3438737A
Cited
US3592603A
Cited
US4260777A
Cited
US4149852A
Cited
US4125376A
Cited
US4287153A
Cited
US4376827A
Cited
US4511660A
Cited
GB2132348A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-09-16 | 1995-03-18 | 1995-09-17 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-09-16 | 1999-03-18 | 1999-09-17 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-09-16 | 2003-03-18 | 2003-09-17 | $7700.00 | Window Closed / Lapsed |