EP0169055A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Polymeric single layer analytical element
Assignee: Bayer Corp
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Filing: 1985-07-16
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Granted: —
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Expires: 2005-07-16
Abstract
Abstract A device (10) for determining an analyte in a fluid sample consists essentially of a dimensionally stable, uniformly porous, diffusely reflective single layer (20) formed of a polymeric non-fibrous matrix and, dispersed throughout said matrix, at least one substance which effects a detectable response to the analyte. Preferably, the polymer is a high density polyethylene treated to be hydrophilic. The optical properties of the device can be further modified by blending in pigments, such as titanium dioxide. The analyte-responsive substance can include a first component which is responsive to the analyte to form a reaction product and a second component separated from the first component binder and responsive to the reaction product to effect a detectable change. The device is completely effective in the absence of other elements or structures to provide a quantitative detectable response to the presence of the analyte under assay.
Inventors
- 👤 Anand Kumar
- 👤 Leong Koon-Wah
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-05 06:24
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; C; C12; C12Q; C12Q1/00
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
48 words
A device for determining an analyte in a fluid sample, which device consists essentially of a dimensionally stable, uniformly porous, diffusely reflective single layer (20) formed of a polymeric non-fibrous matrix and, dispersed throughout said matrix, at least one substance which effects a detectable response to said analyte.
Claim 2
Independent Claim
48 words
A device for determining an analyte in a fluid sample, which device consists essentially of a dimensionally stable, uniformly porous, diffusely reflective single layer (20) formed of a polymeric non-fibrous matrix and, dispersed throughout said matrix, at least one substance which effects a detectable response to said analyte.
Claim 3
Dependent Claim
61 words
A device according to claim 1, wherein the matrix is of a high density polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyvinylidene fluoride, polytetrafluroethylene, nylon, polyvinylchloride, polyester, polysulfone or any blend of two or more thereof, and wherein the matrix optionally is coated with a hydrophilic surfactant, which is preferably selected from polyoxyethylene octyl phenols, polyoxyethylene nonyl phenols, and polyoxyethylene lauryl ethers.
Claim 4
Dependent Claim
107 words
A device according to claim 1 or 2, wherein (a) the analyte is alanine aminotransferase and the analyte responsive substance comprises alanine, NADH, pyridoxal phosphate, 2,-oxoglutarate sodium salt and lactate dehydrogenase; or (b) the analyte is sodium and the analyte-responsive substance comprises a compound selected from 2-hydroxy-5-(4-nitrophenylazo)-phenyloxy-methyl-15-crown-5 and 4'-(2",4"-dinitro-6"-trifluromethylphenyl) aminobenzo-15-crown-5; or the analyte is potassium and the analyte-responsive substance comprises a compound selected from 4'-(2",4"-dinitro-6"-trifluromethylphenyl) aminobenzo-18- crown-6 and 41-picrylaminobenzo-18-crown-6; or the analyte is bilirubin and the at least one analyte-responsive substance includes a diazo compound and a displacing agent, the diazo compound preferably being diazo sulfanilic acid, and the displacing agent preferably being diphylline, caffeine or dimethylsulfoxide.
Claim 5
Dependent Claim
41 words
A device according to claim 1 or 2, wherein the analyte-responsive substance includes a first component which is responsive to the analyte to form a reaction product, and a second component responsive to the reaction product to effect a detectable change.
Claim 6
Dependent Claim
83 words
A device according to claim 4, wherein (a) the analyte is ammonia, the first component is effective to convert ammonium ions to ammonia, the second component is bromcresol green and the first and second components are maintained separate by a gas (e.g. ammonia) permeable polymer; or (b) the first component is reactive with the analyte to produce hydrogen peroxide and the second component includes a peroxidatively active substance and a redox indicator and is reactive with hydrogen peroxide to produce a detectable response.
Claim 7
Dependent Claim
49 words
A device according to claim 5, wherein (a) the analyte is cholesterol and the first component includes cholesterol oxidase and cholesterol ester hydrolase; or (b) the analyte is uric acid and the first component includes uricase; or (c) the analyte is glucose and the first component includes glucose oxidase.
Claim 8
Dependent Claim
120 words
A device according to claim 1 or 2, wherein the analyte-responsive substance comprises reagents for a homogeneous specific binding assay system which produces a detectable response that is a function of the presence of the analyte in the sample, and wherein preferably (a) said homogeneous specific binding assay system includes a label which participates in an enzymatic reaction; or (b) said homogeneous specific binding assay system comprises an antibody which binds said analyte, a conjugate of said analyte or a binding analog thereof and a label, and a detectant system which interacts with said label to produce a detectable response that is different when the label conjugate is bound by the antibody compared to when it is not so bound.
Claim 9
Independent Claim
68 words
A device according to any of claims 1 to 7, which further comprises at least one macromolecular substance which reduces the migration of reagent within the matrix, the macromolecular substance preferably being selected from protein, gum or wax or a polymer, the polymer preferably being cellulose acetate, polyvinyl chloride, nylon, polyacrylates, starch, polycarbonate, polyvinyl alcohol, polyvinyl acetate, dextran, polyvinyl pyrrolidone, polyurethane, cellulose, cellulose nitrate or cellulose acetate butyrate.
Claim 10
Independent Claim
58 words
A device according to any of claims 1 to 8, which further comprises irregularly shaped, reflective, inorganic particles which are preferably selected from basic lead hydroxide, basic lead carbonate, titanium dioxide, zinc oxide, magnesium oxide, barium sulfate, calcium sulfate, strontium sulfate, silica, calcite, silicates, aluminosilicates, zinc sulfide, diatomaceous earth, clay or any mixture of two or more thereof.
Claim 11
Independent Claim
40 words
A method for determining an analyte in a fluid sample, which method comprises contacting the sample suspected to contain the analyte with a device as claimed in any preceding claim appropriate to said analyte, and observing for a detectable response.
References Cited (Backward Citations)
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