Miles Inc.

Arthur L Lau

James H Pendergrass

Carrie A Ritucci

Timothy M Coryn

David W Thompson

A method of manufacturing a test device for 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 used 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.

Method of manufacturing a test article for the determination of protein

A method and composition for the assay for albumin at an essentially neutral to an alkaline pH. The method utilizes indicator dyes that, when sufficiently buffered in a pH range of approximately 6 to approximately 8, allows the detection of albumin in urine or serum. The indicator dyes utilized in the method of the present invention have the general formula: ##STR1## wherein R.sub.1 and R.sub.2 are substituted aromatic heterocyclic or carbocyclic moieties having one or more electron-withdrawing functionalities present on the aromatic ring; R.sub.3 is a substituted aromatic heterocyclic or carbocyclic moiety having one or more electron-withdrawing functionalities present on the aromatic ring, or R.sub.3 is a non-aromatic electron-withdrawing moiety; R.sub.4 is a substituted quasi-aromatic quinone-like heterocyclic or carbocyclic moiety having one or more electron-withdrawing functionalities present on the quasi-aromatic quinone-like ring; and R.sub.5 is a substituted aromatic heterocyclic or carbocyclic moiety having one or more electron-withdrawing functionalities, including at least one hydroxy functionality, present on the aromatic ring.

Composition for the assay of albumin

A test device and method of determining the presence and concentration of proteins, including albumin and Bence Jones proteins, in a test sample are disclosed. The test device includes a test pad comprising a new and improved carrier matrix incorporating an indicator reagent composition capable of interacting with proteins to produce a visually or instrumentally detectable and/or measurable response. The new and improved carrier matrix of the test pad comprises a fibrous, bibulous substrate, such as filter paper, homogeneously impregnated with a polymerized urethane-based compound dispersed in a liquid vehicle comprising an aprotic solvent and an alcohol. The resulting non-greening carrier matrix provides improved color resolution and increased sensitivity to proteins in dry phase test strip assays, thereby affording a more accurate and trustworthy protein assay of liquid test samples, such as urine. The non-greening carrier matrix also essentially eliminates indicator reagent composition runover onto adjacent test pads, such as a pH test pad, in test strips used to assay for more than one analyte. Also disclosed is a method of making the device.

Method and device for determining protein using carrier matrix

A test device and method of determining the presence and concentration of proteins in a test sample are disclosed. The test device includes a test pad comprising a new and improved carrier matrix incorporating an indicator reagent composition capable of interacting with proteins to produce a detectable or measurable response. The new and improved carrier matrix of the test pad comprises a film, membrane or layer of a polymerized urethane-based compound, a water insoluble inorganic compound and an insoluble organic compound. The carrier matrix provides improved color resolution and increased sensitivity to proteins in dry phase test strip assays, thereby achieving an accurate and trustworthy protein assay of a liquid test sample, such as urine, having a protein concentration as low as about 5 mg/dL. Also disclosed is a method of making the test device.

Method and device for determining protein using carrier matrix composed

A new and improved method and composition for determining the presence and concentration of low to trace amounts of proteins, such as albumin, in a test sample, such as urine. The method includes using a reagent composition capable of interacting with low trace amounts of proteins to produce a visually or instrumentally detectable and/or measurable response. The method can be used in wet assays or in dry test strip assays, wherein the reagent composition is incorporating into a carrier matrix. The new and improved reagent composition, comprising a dye, such as a polyhydroxybenzenesulfonephthalein-type indicator, like pyrocatechol violet; a tungstate, such as ammonium tungstate; and, if necessary, a suitable buffer, is incorporated into the carrier matrix to provide sufficient sensitivity to low to trace protein levels and sufficient color resolution between low to trace protein levels, thereby affording an accurate and trustworthy protein assay of test samples having a low protein concentration.

Composition for determining trace amount of protein

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 used 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.

Method for assaying for proteins using a dual indicator reagent

A new and improved composition and method of determining the specific gravity of an aqueous test sample. The method includes using a test device comprising a carrier matrix incorporating a reagent composition capable of interacting with an aqueous test sample to produce a visually or instrumentally detectable and measurable response that correlates to the specific gravity of the aqueous test sample. The new and improved reagent composition, comprising a molybdate-dye complex indicator, such as a molybdatepyrocatechol violet complex; a protein, such as albumin; a chelating agent, like tartaric acid; and, if necessary, a suitable buffer, is incorporated into a carrier matrix, like filter paper, to provide increased sensitivity to test sample specific gravity and improved color differentiation between test samples having different specific gravities, thereby affording a more accurate and trustworthy specific gravity assay of an aqueous test sample, such as urine.

Composition and method of assaying aqueous liquids for specific gravity

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.

Composition and test device for assaying for proteins

A new and improved method and composition for determining the presence and concentration of low to trace amounts of proteins, such as albumin, in a test sample, such as urine. The method includes using a reagent composition capable of interacting with low to trace amounts of proteins to produce a visually or instrumentally detectable and/or measurable response. The method can be used in wet assays or in dry test strip assays, wherein the reagent composition is incorporating into a carrier matrix. The new and improved reagent composition, comprising a dye, such as a polyhydroxybenzenesulfonephthalein-type indicator, like pyrocatechol violet; a tungstate, such as ammonium tungstate; and, if necessary, a suitable buffer, is incorporated into the carrier matrix to provide sufficient sensitivity to low to trace protein levels and sufficient color resolution between low to trace protein levels, thereby affording an accurate and trustworthy protein assay of test samples having a low protein concentration.

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Granger, IN, United States of America

Arthur L Lau