Reagent materials and associated test elements

• US 8,921,061 B2
• Filed: 11/02/2012
• Issued: 12/30/2014
• Est. Priority Date: 11/02/2012
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wilsey, Christopher D.
• Primary Examiner(s): KAM, CHIH MIN
• Application Number:
  US13/667,057
• Publication Number:
  US 20140127728A1
• Time in Patent Office: 788 Days
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

Reagent materials and associated test elements are provided. In one embodiment, a test element having dual functionality includes a first coenzyme-dependent enzyme or a substrate for the first enzyme, a second coenzyme-dependent enzyme or a substrate for the second enzyme, and a coenzyme selected from the group consisting of thio-NAD, thio-NADP, and a compound according to formula (I). In one aspect, the first analyte is hydroxybutyrate and the first enzyme is a hydroxybutyrate dehydrogenase, and the second analyte is glucose and the second enzyme is a glucose dehydrogenase or a glucose oxidase. Other aspects of the subject application are directed to unique reagent materials. Further embodiments, forms, objects, features, advantages, aspects, and benefits shall become apparent from the description and drawings.

Claims

1. A test element configured for determining first and second analytes, comprising:

a first coenzyme-dependent enzyme or a substrate for the first enzyme, wherein the first analyte is hydroxybutyrate and the first coenzyme-dependent enzyme is a hydroxybutyrate dehydrogenase;

a second coenzyme-dependent enzyme or a substrate for the second enzyme, wherein the second analyte is glucose and the second coenzyme-dependent enzyme is a glucose dehydrogenase or a glucose oxidase; and

a coenzyme selected from the group consisting of thio-NAD, thio-NADP, and a compound according to formula (I);

2. The test element of claim 1, wherein the hydroxybutyrate dehydrogenase is 3-hydroxybutyrate dehydrogenase.

3. The test element of claim 1, wherein the coenzyme is a compound according to formula (I)

4. The test element of claim 1, wherein the coenzyme is a compound according to formula (I)

5. The test element of claim 1, wherein the coenzyme is thio-NAD.

6. The test element of claim 1, wherein the coenzyme is thio-NADP.

7. The test element of claim 1, wherein the first enzyme or the substrate for the first enzyme and the coenzyme selected from the group consisting of thio-NAD, thio-NADP and the compound according to formula (I) or a salt or optionally a reduced form thereof are included in a first reagent material.

8. The test element of claim 7, wherein the second enzyme or the substrate for the second enzyme and the coenzyme selected from the compound according to formula (I) or a salt or optionally a reduced form thereof are included in a second reagent material.

9. The test element of claim 8, wherein the test element is a test strip configured to carry the first and second reagent materials.

10. The test element of claim 9, wherein the test strip includes a first electrode system associated with the first reagent material and a second electrode system associated with the second reagent material.

11. The test element of claim 8, wherein the second reagent material further comprises FAD, NAD or NADP.

12. The test element of claim 7, wherein the first reagent material further comprises one of nitrosoaniline, potassium ferricyanide, and a combination of a phenazine compound and hexaammineruthenium chloride.

13. A reagent material, comprising:

3-hydroxybutyrate dehydrogenase; and

a coenzyme compound according to formula (I);

14. The reagent material of claim 13, wherein the coenzyme compound is according to formula (I)

15. The reagent material of claim 13, wherein the coenzyme compound is according to formula (I)

16. The reagent material of claim 13, further comprising one of nitrosoaniline, potassium ferricyanide, and a combination of a phenazine compound and hexaammineruthenium chloride.

17. A test element, comprising a test strip carrying a first reagent material according to claim 13 for determining a first analyte, wherein the first analyte is hydroxybutyrate.

18. The test element of claim 17, wherein the test strip further carries a second reagent material for determining a second analyte, wherein the second analyte is glucose.

19. The test element of claim 18, wherein the second reagent material includes a glucose dehydrogenase or a glucose oxidase.

20. The test element of claim 19, wherein the second reagent material further includes a coenzyme selected from the group consisting of FAD, NAD, NADP and a compound according to formula (I):

21. The test element of claim 18, wherein the test strip is configured for electrochemical determination of the first and second analytes.