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Last Updated: March 29, 2024

Claims for Patent: 6,436,716


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Summary for Patent: 6,436,716
Title: Aldehyde test strip
Abstract:A composition, method, and device for quantitatively determining the concentration of an aldehyde in a sample are disclosed. The device includes a test pad having a suitable carrier matrix incorporating an indicator reagent composition capable of interacting with the aldehyde to produce a detectable and measurable response for aldehyde concentration over a range of 0% to over 4%, by weight of the sample. An indicator reagent composition contains: (a) a protein, (b) an amine, (c) a color indicator, (d) preferably a neutral, nonionic polymer, such as a water-soluble cellulose polymer, and (e) a carrier. An indicator reagent composition is incorporated into a carrier matrix, like filter paper, to provide a test pad useful in a dry phase aldehyde assay of a sample, especially for samples containing a high concentration of glutaraldehyde or formaldehyde.
Inventor(s): Wu; Wen H. (Elkhart, IN)
Assignee: Integrated Biomedical Technology, Inc. (Elkhart, IN)
Application Number:09/583,050
Patent Claims:1. A composition comprising: (a) about 1% to about 25%, by weight, of a protein; (b) about 5% to about 25%, by weight, of an amine; (c) a color indicator; (d) an optional polymer; and (e) a carrier comprising water, said composition capable of exhibiting a detectable and measurable color transition in response to a concentration of 0% to greater than 4%, by weight, of an aldehyde.

2. The composition of claim 1 wherein the protein comprises bovine serum albumin, human serum albumin, ovalbumin, gamma globulin, or a mixture thereof.

3. The composition of claim 1 wherein the amine is an amino acid or a peptide comprising at least two amino acids of the formula: ##STR3##

wherein R is hydrogen or alkyl, optionally substituted with amino, guanidino, carboxy, sulfhydryl, hydroxy, ureido, or hydroxy.

4. The composition of claim 3 wherein the amino acid comprises alanine, asparagine, glycine, lysine, arginine, aspartic acid, glutamic acid, cysteine, serine, ornithine, citrulline, or threonine.

5. The composition of claim 3 wherein the peptide comprises two to about five amino acids.

6. The composition of claim 3 wherein the peptide comprises glycylglycine.

7. The composition of claim 1 wherein the amine compound is present in an amount of about 10% to about 20%, by weight of the composition.

8. The composition of claim 1 wherein the optional polymer is a neutral, nonionic polymer.

9. The composition of claim 8 wherein the polymer comprises a water-soluble, cellulose-based polymer.

10. The composition of claim 8 wherein the cellulose-based polymer is selected from the group consisting of methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxyethylmethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose and salts thereof, hydroxybutylcellulose, cellulose acetate, carboxymethylhydroxyethylcellulose, hydroxybutylmethylcellulose, and mixtures thereof.

11. The composition of claim 8 wherein the polymer comprises hydroxyethylcellulose.

12. The composition of claim 10 wherein the polymer comprises a water-soluble polymer selected from the group consisting of polyvinylpyrrolidone, hydrolyzed polyvinylpyrrolidone, poly(vinyl alcohol), poly(vinyl acetate), vinyl acetate-vinyl alcohol copolymer, poly(methacrylamide), a polyoxypropylene-polyoxyethylene block polymer having a structure: ##STR4##

wherein x and z, independently, are an integer from about 4 to about 30, and y is an integer from about 4 to about 100, polyacrylamide, a vinyl alcohol copolymer, and mixtures thereof.

13. The composition of claim 1 wherein the polymer comprises an amount of 0% to about 5%, by weight of the composition.

14. The composition of claim 1 further comprising a nonionic or an anionic surfactant in an amount of 0% to about 1.5% by weight of the composition.

15. The composition of claim 14 wherein the surfactant is selected from the group consisting of an ethoxylated polysorbate, an ethoxylated alcohol, an ethoxylated phenol, a polyethylene glycol, a polypropylene glycol, an ethylene glycol-propylene glycol copolymer, an alkyl sulfate, an alkyl ether sulfate, an alkyl ether sulfonate, a sulfate ester of an alkylphenoxy polyoxyethylene ethanol, an alpha-olefin sulfonate, a beta-alkyloxy alkane sulfonate, an alkyl arylsulfonate, an alkyl carbonate, an alkyl ether carboxylate, a fatty acid, a sulfosuccinate, an alkyl ether sulfosuccinate, a sarcosinate, an octoxynol phosphate, a nonoxynol phosphate, a taurate, a fatty tauride, a sulfated monoglyceride, a fatty acid amido polyoxyethylene sulfate, and mixtures thereof.

16. The composition of claim 1 comprising: (a) about 1% to about 25% by weight protein; (b) about 5% to about 25% by weight amino acid or peptide; (c) about 0.005% to about 0.015% by weight color indicator; (d) about 0.2% to about 5% by weight of hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, hydroxymethylcellulose, carboxymethylcellulose, polyvinylpyrrolidone, and mixtures thereof.

17. The composition of claim 1 wherein the carrier further comprises an organic solvent.

18. The composition of claim 19 wherein the organic solvent comprises methanol, ethanol, or acetone.

19. The composition of claim 1 wherein the composition has a pH of from about 5 to about 11.

20. The composition of claim 1 wherein the color indicator changes color in the range from about pH 3 to about pH 12.

21. The composition of claim 1 wherein the color indicator is selected from the group consisting of bromphenol blue, tetrabromophenol blue, Congo red, methyl orange, bromchlorphenol blue, p-ethoxychrysoidine, alpha-naphthyl red, sodium alizarinsulfonate, bromcresol green, 2,5-dinitrophenol, methyl red, lacmoid, litmus, chlorphenol red, benzoyl auramine G, azolitmin, bromcresol purple, bromphenol red, dibromophenol-tetra-bromophenol-sulfonphthalein, p-nitrophenol, bromothymol blue, phenol red, neutral red, rosolic acid aurin, quinoline blue, cresol red, alpha-naphtholphthalein, metacresol purple, ethyl bis[2,4-dinitrophenyl]acetate, tropaeolin, thymol blue, o-cresolphthalein, phenolphthalein, thymolphthalein, Nile blue A, alpha-naphtholbenzein, alizarin yellow GG, alizarin yellow R, and mixtures thereof.

22. A method of determining aldehyde content of a sample containing 0% to greater than 4% by weight aldehyde, said method comprising: (a) contacting the sample with an indicator reagent composition comprising: (i) about 1% to about 25%, by weight, of a protein, (ii) about 5% to about 25%, by weight, of an amine, (iii) a color indicator, and (iv) an optional polymer; and (b) determining the aldehyde content of the sample from the intensity and degree of a color transition of the indicator reagent composition.

23. The method of claim 20 wherein the sample has an aldehyde content of 0.5% to greater than 4% by weight aldehyde.

24. The method of claim 22 wherein the aldehyde is glutaraldehyde or formaldehyde.

25. The method of claim 22 wherein the intensity and degree of the color transition are determined visually or instrumentally.

26. The method of claim 22 wherein the amine is an amino acid or a peptide.

27. The method of claim 22 wherein the sample is an aqueous sample or a gaseous sample.

28. A method of quantitatively determining the aldehyde content of a sample containing 0% to greater than 4% by weight aldehyde, said method comprising: (a) contacting the sample with an analyte detection device comprising a test pad, said test pad having incorporated therein an indicator reagent composition comprising a carrier matrix impregnated with a solution comprising: (i) about 1% to about 25%, by weight, of a protein, (ii) about 5% to about 25%, by weight, of an amine, (iii) a color indicator, and (iv) an optional polymer; and (b) determining the aldehyde content of the aqueous sample from the intensity and degree of a color transition of the indicator reagent composition.

29. The method of claim 28 wherein the aldehyde is glutaraldehyde or formaldehyde.

30. The method of claim 28 wherein the aldehyde is present in an aqueous solution or in a gaseous vapor.

31. The method of claim 28 wherein the amine is an amino acid or peptide.

32. A method of determining the aldehyde content of an aqueous sample comprising: (a) contacting the aqueous sample with an analyte detection device comprising a test pad having incorporated therein a solution comprising: (i) about 1% to about 25%, by weight, of a protein, (ii) about 5% to about 25%, by weight, of an amine, (iii) a color indicator, (b) examining the analyte detection device for a color transition; and (c) correlating the color transition to the aldehyde content of the aqueous sample.

33. The method of claim 32 wherein the aqueous sample has an aldehyde content of 0% to about 4% by weight.

34. The method of claim 32 wherein the aldehyde is glutaraldehyde or formaldehyde.

35. The method of claim 32 wherein the amine is an amino acid or peptide.

36. An analyte-detection device to determine the aldehyde content of an aqueous sample comprising: a support strip; a test pad; and an indicator reagent composition incorporated into the test pad, said reagent composition comprising: (a) about 1% to about 25%, by weight, of a protein, (b) about 5% to about 25%, by weight, of an amine, (c) a color indicator, and (d) an optional polymer.

Details for Patent 6,436,716

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2040-01-28
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2040-01-28
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2040-01-28
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2040-01-28
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 02/17/1995 ⤷  Try a Trial 2040-01-28
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 06/11/2003 ⤷  Try a Trial 2040-01-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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