Methods of determining glucose and ketone values in a sample

• US 9,416,397 B2
• Filed: 11/21/2014
• Issued: 08/16/2016
• Est. Priority Date: 11/02/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Wilsey, Christopher D.
• Primary Examiner(s): NASHED, NASHAAT T
• Application Number:
  US14/549,724
• Publication Number:
  US 20150140584A1
• Time in Patent Office: 634 Days
• Field of Search: None
• US Class Current: 1/1
• 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 method of determining glucose and ketone values in a sample, the method comprising the steps of:

providing a test element configured for electrochemically determining glucose and ketone values in a sample;

contacting the test element with the sample, wherein the test element includes;

a first reagent material comprising a first coenzyme-dependent enzyme for determining the ketone value and at least one first reagent material coenzyme selected from the group consisting of thio-NAD, thio-NADP and a compound according to formula (I), wherein the first reagent material is associated with a first electrode system of the test element, and

a second reagent material comprising a second coenzyme-dependent enzyme for determining the glucose value and at least one second reagent material coenzyme selected from the group consisting of FAD, NAD, NADP, thio-NAD, thio-NADP and the compound according to formula (I), wherein the second reagent material is associated with a second electrode system of the test element,

wherein the compound according to formula (I) is as follows;

2. The method of claim 1, wherein the first coenzyme-dependent enzyme is a hydroxybutyrate dehydrogenase and the second coenzyme-dependent enzyme is a glucose dehydrogenase or a glucose oxidase.

3. The method of claim 1, wherein the step of determining glucose and ketone values in the sample is completed within 5 seconds after contacting the test element with the sample.

4. The method of claim 1, wherein the glucose and ketone values are determined within 2 seconds of one another during the determining step.

5. The method of claim 1, wherein the sample comprises blood.

6. The method of claim 2, wherein the hydroxybutyrate dehydrogenase is 3-hydroxybutyrate dehydrogenase.

7. The method of claim 1, wherein the at least one first reagent material coenzyme and the at least one second reagent material coenzyme is a compound according to formula (I):

8. The method of claim 1, wherein the at least one first reagent material coenzyme and the at least one second reagent material coenzyme is a compound according to formula (I):

9. The method of claim 1, wherein the first reagent material further comprises a mediator selected from the group consisting of nitrosoaniline, potassium ferricyanide, and a combination of a phenazine compound and hexaammineruthenium chloride.