Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

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 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.

Abstract: 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.

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.

Abstract: A test means for determining the presence of an ion in an aqueous test sample, a method for preparing it and a method for using it. The test means comprises a hydrophilic carrier matrix incorporated with finely divided globules of a hydrophobic vehicle. The hydrophobic vehicle contains an ionophore capable of forming a complex with the ion and a reporter substance capable of interacting with the complex of ionophore and ion to produce a detectable response. The test means of this invention is useful for clinical determinations of serum potassium. The test means forms the reagent layer in a multilayer format which is particularly suited to whole blood electrolyte determinations and does not require washing or wiping before use.

Abstract: A test means, test device and method for use for determining the presence of an ion in a test sample are disclosed. The test means comprises a substantially nonpolar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with the specific ion and reporter substance capable of interacting with the complex of ionophore and ion to produce a detectable response. The test means disclosed is particularly useful for serum potassium determinations. The test means forms the reagent layer in a multilayer format particularly suited to whole blood electrolyte determinations.