Test-device for threshold glucose detection in urine

• US 6,444,169 B1
• Filed: 06/18/2001
• Issued: 09/03/2002
• Est. Priority Date: 06/18/2001
• Status: Expired due to Term

• Current Assignee: Societe des Produits Nestle SA (Nestle SA), Hach Company (Veralto Corp.)
• Original Assignee: Ralston Purina Company (Nestle SA), Environmental Test Systems, Inc. (Veralto Corp.)
• Inventors: Lewis, Ronald A. II, Dobler, Lydia, Van Lente, Michael A., Evtodienko, Iouri, Evtodienko, Vladimir
• Primary Examiner(s): Snay, Jeffrey
• Assistant Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US09/883,874
• Time in Patent Office: 442 Days
• Field of Search: 435/15, 435/10, 422/56, 422/57, 422/61, 422/68.1, 436/95, 436/169
• US Class Current: 422/420
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Devices and test kits are provided for glucose detection and quantification in urine. The devices and kits comprise a chromogenic indicator mixture comprising a first indicator capable of color development to indicate the presence of a low-to-medium concentration of glucose, a second indicator capable of color development to indicate the presence of a higher concentration of glucose, wherein the first indicator prevents color development of the second indicator unless the higher concentration of glucose is present in the urine, and a non-chromogenic scavenger that interferes with color development of the first indicator when glucose levels are below a threshold concentration, and a carrier impregnated with the chromogenic indicator mixture.

Claims

1. A dry chemistry device for glucose detection and quantification in urine, said device comprising

a chromogenic indicator mixture comprising

a first indicator capable of color development to indicate the presence of a low-to-medium concentration of glucose, and

a second indicator capable of color development to indicate the presence of a higher concentration of glucose, wherein the first indicator prevents color development of the second indicator unless the higher concentration of glucose is present in the urine, wherein the chromogenic indicator mixture further comprises a non-chromogenic scavenger that interferes with color development of the first indicator when glucose levels are below a threshold concentration of glucose;

and a carrier impregnated with the chromogenic indicator mixture.

2. The device of claim 1 wherein the non-chromogenic scavenger comprises cysteine.

3. The device of claim 1 wherein the non-chronogenic scavenger is selected from the group consisting of thiosulfates and mercaptans.

4. The device of claim 1 wherein the threshold glucose concentration is about 50 mg/dL.

5. The device of claim 4 wherein the low-to-medium concentration of glucose is in the range of 150-300 mg/dL.

6. The device of claim 5 wherein the higher concentration of glucose is 300 mg/dL and the second indicator is capable of color development to indicate concentrations of glucose in the range of 300-600 mg/dL.

7. The device of claim 1 wherein the first indicator comprises 4-aminoantipyrene and a phenolic compound.

8. The device of claim 7 wherein the phenolic compound is selected from the group consisting of 2-hydroxy-3,5 -dichlorobenzenesulfonate, 3-methylcatechol, 4-hydroxybenzenesulfonic acid, and 2,6-dimethylphenol.

9. The device of claim 1 wherein the second indicator comprises an iodide salt.

10. The device of claim 9 wherein the iodide salt is potassium iodide and the second indicator further comprises starch.

11. The device of claim 1 wherein the chromogenic indicator mixture further comprises a stabilizer that prevents loss of capacity for color development for at least 24 hours at high humidity.

12. The device of claim 1 wherein the color development remains stable for at least eight hours subsequent to activation.

13. The device of claim 1 wherein the carrier is cellulose paper.

14. The device of claim 13 wherein the cellulose paper is formed into small but visually detectable pieces.

15. The device of claim 1 wherein a resultant color obtained from the color development is independent of the specific gravity of the urine.

16. A device for detection and quantification of glucose in urine comprising:

a chromogenic indicator mixture comprising

a first chromogenic indicator reagent combination capable of color development to indicate the presence of a lower concentration of glucose, and

a second chromogenic indicator reagent combination capable of color development to indicate the presence of a higher concentration of glucose, wherein the first chromogenic indicator prevents color development of the second chromogenic indicator unless the higher concentration of glucose is present,

a scavenger that prevents color development of the first indicator reagent composition unless a threshold concentration of glucose is present, and

a matrix impregnated with the chromogenic indicator mixture.

17. The device of claim 16 wherein said matrix formed into small but visually detectable pieces suitable for application in a litter box.

18. A test kit for determining the concentration of glucose present in a sample of animal urine comprising

a substrate impregnated with a chromogenic indicator mixture comprising

a first indicator capable of color development to indicate the presence of a lower concentration of glucose, and

a second indicator capable of color development to indicate the presence of a higher concentration of glucose, wherein the first indicator prevents color development of the second indicator unless the higher concentration of glucose is present in the urine sample;

wherein the substrate is further impregnated with a scavenger that prevents color development of the first indicator unless a threshold concentration of glucose is present in the urine; and

a color chart indicating urine glucose concentrations corresponding to a plurality of discernible colors.

19. The test kit of claim 18 wherein the color chart provides colors corresponding to urine glucose concentrations of 0, 50, 150, 300, and 600 mg/dL.

20. The test kit of claim 18 wherein the substrate is formed into small but visually detectable pieces.

21. The test kit of claim 18 wherein the substrate is provided in a sealed foil package.