Composition and device for urinary protein assay and method...

G - Physics – 01 – N

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G01N 33/68 (2006.01) C08G 8/36 (2006.01) G01N 33/52 (2006.01)

Patent

CA 2081868

IMPROVED COMPOSITION AND DEVICE FOR URINARY PROTEIN ASSAY AND METHOD OF USING THE SAME Abstract of the Disclosure An improved composition, test device and method of determining the presence or concentration of proteins, such as albumin, in a liquid test sample, such as urine, are disclosed. The test device includes a test pad comprising a carrier matrix incorporating a new and improved indicator reagent composition capable of interacting with proteins to produce a detectable response. The new and improved indicator reagent composition comprises an indicator dye that is capable of interacting with albumin and undergoing a detectable response, such as a color transition; a buffer; a hydrophobic polymeric compound having the general structural formula: Image , (I) wherein A is Image 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 R2 and R3 are selected, independently, from the group consisting of hydrogen, an alkyl group, an aralkyl group, and an aryl group; R1 is either methylene or oxygen; n is a number in the range of one to about 8; and E is hydrogen or methylol when R1 is methylene, or E is hydroxy when R1 is oxygen; and a MS-1667 suitable carrier comprising water. The indicator reagent composition provides an improved color resolution in the test pad, and therefore improved color differentiation between test samples assaying negative to protein and test samples assayed as including a trace amount of protein, thereby substantially reducing the number of false positive assays for protein. MS-1667

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