Catalytic test composition intended to produce a range of colors

• US 4,898,813 A
• Filed: 04/04/1986
• Issued: 02/06/1990
• Est. Priority Date: 04/04/1986
• Status: Expired due to Fees

• Current Assignee: Miles, Inc. (Bayer AG)
• Original Assignee: Miles, Inc. (Bayer AG)
• Inventors: Charlton, Steven C., Albarella, James P., Warchal, Mary E., Reinsch, James W.
• Primary Examiner(s): Rosen, Sam
• Assistant Examiner(s): Saunders, David A.
• Application Number:
  US06/848,691
• Time in Patent Office: 1,404 Days
• Field of Search: 435/4, 435/11, 435/14, 435/15, 435/18, 435/25, 435/26, 435/28, 435/805, 435/19, 422/55-57, 436/800, 436/805
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/80 Fluorescent dyes, e.g. rhodamine
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

Test compositions and test devices are provided which are capable of generating different hues at different analyte concentrations. Visual results for clinically important analytes, such as glucose and cholesterol, are provided by use of compositions containing two independent catalytic systems which are reactive with a common substrate generated from the analyte of interest, to produce visual endpoints of different hues for different concentrations of analyte. Preferred formulations provide a RAINBOW of hues, the particular final hue produced depending on the concentration of the analyte.

Claims

1. Process for determining the concentration of an analyte in a fluid sample, which process comprises:

contacting a common substrate generating system capable of generating a common substrate by reaction with an analyte of interest, with (a) an analyte, (b) a first catalytic system capable of generating a change in hue of a first indicator component by reaction with the common substrate, and (c) a second catalytic system capable of generating a change in hue of a second indicator component by reaction with the common substrate,

wherein the generation of the change in hues of the first and second indicator components occurs substantially simultaneously and provides different hues at different analyte concentrations, the final hue depending on the concentration of the analyte.

2. The process of claim 1 in which a color retardant is added to delay the reaction of the common substrate with a catalytic systems.

3. The test composition of claim 2 in which the color retardant is potassium ferrocyanide.

4. The test composition for the determination of the concentration of an analyte in a fluid sample, comprising:

(a) a common substrate generating system which in the presence of an analyte in a fluid sample will generate a common substrate selected from the group consisting of adenosine triphosphate, reduced flavin adenine dinucleotide, hydrogen peroxide, glycerol and glucose;

(b) a first catalytic system capable of generating a change in hue in a first indicator upon reaction with the common substrate; and

(c) a second catalytic system capable of generating a change in hue in a second indicator by reaction with the common substrate,

wherein the generation of the change in hues of the first and second indicators occurs substantially simultaneously and provides different hues at different analyte concentrations, the final hue produced by the test composition depending on the concentration of the analyte present in the fluid sample.

5. The test composition of claim 4 in which the common substrate generating system is glucose oxidase and the analyte is glucose.

6. The test composition of claim 4 in which the common substrate generating system is cholesterol oxidase and the analyte is cholesterol.

7. The test composition of claim 4 in which the common substrate generating system is alcohol oxidase and the analyte is alcohol.

8. The test composition of claim 4 in which the common substrate generating system is lipoprotein lipase and the analyte is triglyceride.

9. The test composition of claim 8 in which the first catalytic system comprises glycerolkinase and the second catalytic system comprises glycerol dehydrogenase.

10. The test composition of claim 4 in which the common substrate generating system is alpha amylase and the analyte is alpha amylase.

11. The test composition of claim 10 in which the first catalytic system comprises hexokinase and the second catalytic system comprises glucose dehydrogenase.

12. The test composition of claim 4 in which the change in hue of one of the first or second indicators is from a hue to substantially colorless.

13. The test composition of claim 4 in which a color retardant is added to the test composition to delay the reaction of the common substrate with the catalytic systems.

14. The test composition of claim 4 which also contains a buffer for maintaining the pH of the test composition between about 6 and 9.

15. The test device for the determination of concentration of an analyte in a fluid sample comprising:

a carrier matrix, and

a test composition incorporated into the carrier matrix, said test composition comprising;

(a) a common substrate generating system which in the presence of an analyte in a fluid sample will generate a common substrate selected from the group consisting of adenosine triphosphate, reduced flavin adenine dinucleotide, hydrogen peroxide, glycerol and glucose;

(b) a first catalytic system capable of generating a change in hue in a first indicator upon reaction with the common substrate; and

(c) a second catalytic system capable of generating a change in hue in a second indicator by reaction with the common substrate,

wherein the generation of the change in hues of the first and second indicators occurs substantially simultaneously and provides different hues at different analyte concentrations, the final hue produced by the test composition depending on the concentration of the analyte present in the fluid sample.

16. The test device of claim 15 in which at least one indicator component is compartmentalized within the carrier matrix.

17. The test device of claim 16 in which at least one indicator component is compartmentalized within a gelatin layer within a carrier matrix.

18. The test device of claim 15 in which the carrier matrix is paper.

19. The test device of claim 15 in which the carrier matrix is a hydrophilic carrier.