US 5,326,707 A · Composition and device for urinary protein assay and method of using the same

Abstract

A composition, test device and method of determining the presence or concentration of proteins, such as albumin, in a liquid test sample, such as urine. The test device includes a test pad with a carrier matrix incorporating a indicator reagent composition capable of interacting with proteins to produce a detectable response. The indicator reagent composition includes an indicator dye that is capable of interacting with albumin and undergoing a detectable color transition; a buffer; a hydrophobic polymeric compound having the general structural formula: ##STR1## wherein A is ##STR2## and PO is an oxypropylene unit, EO is an oxyethylene unit, y is a number in the range of 0 to about 20, z is a number in the range of 0 to about 20, the sum y+z is a number in the range of about 2 to about 20, and R.sub.2 and R.sub.3 are selected, independently, from the group consisting of hydrogen, an alkyl group, an aralkyl group, and an aryl group; R.sub.1 is either methylene or oxygen; n is a number in the range of one to about 8; and E is hydrogen or methylol when R.sub.1 is methylene, or E is hydroxy when R.sub.1 is oxygen; and a suitable carrier which is water. The indicator reagent composition provides an improved color resolution in the test samples raving negative protein and trace amount of protein.

Claims28

Dependent claims

An indicator reagent composition capable of exhibiting a sufficient color transition upon contacting a protein-containing test sample to demonstrate the presence or concentration of protein in the test sample consisting essentially of:

(a) an indicator dye capable of interacting with a protein and exhibiting a color transition upon such interaction, said indicator dye being present in an amount of about 0.05 to about 0.6 millimoles per liter of the composition and wherein the indicator dye is selected from the group consisting of 3',3",5,5"-tetraiodo-3,4,5,6-tetrabromophenolsulfophthalein, 3,3"-diiodo-5,5",3,4,5,6-hexabromophenolsulfophthalein, and combinations thereof;
(b) a buffer present in an amount of about 250 to about 750 millimoles per liter of the composition wherein the buffer is selected from the group consisting of citric acid, maleic acid, tartaric acid, phthalic acid, sulfosalicyclic acid, succinic acid, malonic acid, their respective alkali metal and ammonium salts and combinations thereof;
(c) a hydrophobic polymeric compound present in an amount of about 1% to about 8% by weight per milliliter of the composition having the general structural formula:
H--[--A--R.sub.1 --].sub.n --A--E,
wherein A is ##STR18## and PO is an oxypropylene unit, EO is an oxyethylene unit, y is a number in the range of 0 to about 20, z is a number in the range of 0 to about 20, the sum of y+z is a number in the range of about 2 to about 20, and R.sub.2 and R.sub.3 are selected, independently, from the group consisting of hydrogen, alkyl group, an aralkyl group, and an aryl group;
R.sub.1 is methylene or oxygen;
n is a number in the range of 1 to about 8;
and
E is hydrogen or methylol when R.sub.1 is methylene, or E is hydroxy when R.sub.1 is oxygen;
and
(d) a carrier vehicle for said composition.

8 more elements

The method of contacting a test sample with an indicator reagent composition to determine the presence of concentration of protein in the test sample, said method being essentially free of interferences attributed to specific gravity, said method comprising the steps of:

(i) contacting the test sample with an indicator reagent composition consisting essentially of:
(a) an indicator dye capable of interacting with a protein and exhibiting a color transition upon such interaction, said indicator dye being present in an amount of about 0.05 to about 0.6 millimoles per liter of the composition and wherein the indicator dye is selected from the group consisting of 3',3",5,5"-tetraiodo-3,4,5,6-tetrabromophenolsulfophthalein, 3,3"-diiodo-5,5",3,4,5,6-hexabromophenolsulfophthalein, and combinations thereof;
(b) a buffer present in an amount of about 250 to about 750 millimoles per liter of the composition wherein the buffer is selected from the group consisting of citric acid, maleic acid, tartaric acid, phthalic acid, sulfosalicylic acid, succinic acid, malonic acid, their respective alkali metal and ammonium salts and combinations thereof;
(c) a hydrophobic polymeric compound present in an amount of about 1% to about 8% by weight per milliliter of the composition having the general structural formula:
H--[--A--R.sub.1 --].sub.n --A--E,
wherein A is ##STR21## and PO is an oxypropylene unit, EO is an oxyethylene unit, y is a number in the range of 0 to about 20, z is a number in the range of 0 to about 20, the sum of y+z is a number in the range of about 2 to about 20, and R.sub.2 and R.sub.3 are selected, independently, from the group consisting of hydrogen, alkyl group, an aralkyl group, and an aryl group;
R.sub.1 is methylene or oxygen;
n is a number in the range of 1 to about 8;
and
E is hydrogen or methylol when R.sub.1 is methylene, or E is hydroxy when R.sub.1 is oxygen;
and
(d) a carrier vehicle for said composition;
and
(ii) determining the presence or concentration of protein in the test sample from a resulting intensity or degree of the color transition of the indicator reagent composition.

11 more elements

Dependencies are inferred from the claim text.

Composition and device for urinary protein assay and method of using the same

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Composition and device for urinary protein assay and method of using the same

Life of this patent

Abstract

Claims28