Matrix composition with alkylphenazine quaternary salt and a nitrosoaniline

• US 8,008,037 B2
• Filed: 03/27/2008
• Issued: 08/30/2011
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wieder, Herbert, Ghoshal, Mitali, Wilsey, Christopher D.
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US12/056,473
• Publication Number:
  US 20090246808A1
• Time in Patent Office: 1,251 Days
• Field of Search: 435/14, 435/26, 544/35, 544/332
• US Class Current: 435/26
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)

Abstract

A chemistry matrix for use in determining the concentration of an analyte in a biological fluid includes a glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline. The chemistry matrix is used with an electrochemical biosensor to determine the concentration of an analyte after a reaction occurs within the biosensor, at which time an analysis is completed to determine the concentration. A method of determining the concentration of an analyte using the chemistry matrix of glucose dehydrogenase, nicotinamide adenine dinucleotide, an alkylphenazine quaternary salt, and/or a nitrosoaniline is another aspect that is described. The method also further features test times of five seconds or less. Methods utilizing the new chemistry matrix can readily determine an analyte such as blood glucose at concentrations of from about 20-600 mg/dL at a pH of from about 6.5 to about 8.5.

Claims

1. A chemistry matrix composition for use in determining the concentration of an analyte with reduced interference from other constituents present with the analyte, the matrix comprising glucose dehydrogenase, nicotinamide adenine dinucleotide, a 5-alkylphenazine quaternary salt, and a nitrosoaniline, wherein said matrix is stable at a pH of from about 6.5 to about 8.5 and is photochemically stable.

2. The composition of claim 1, wherein the 5-alkylphenazine quaternary salt is a compound having the formula:

3. The composition of claim 1, wherein the nitrosoaniline is a compound having the formula:

4. The chemistry matrix of claim 2, wherein R¹ is C₂H₅.

5. The chemistry matrix of claim 4, wherein said nitrosoaniline has the formula:

6. The chemistry matrix composition of claim 5, wherein Z is —

OY;

Y is —

(CH₂)_nCOOQ;

Q is OH; and

n=3.

7. The chemistry matrix composition of claim 5, wherein Z is —

OY;

Y is —

(CH₂)_nCOOQ;

Q is —

NHCH₂CH₂—

(OCH₂CH₂)_o- G;

G is —

COOH; and

o is 4.

8. The chemistry matrix composition of claim 5, wherein Z is —

OY;

Y is —

(CH₂)_nQ;

Q is —

NH₂ and n is 4.

9. The chemistry matrix composition of claim 5, wherein Z is —

OY;

Y is —

(CH₂)_nQ;

Q is —

OH and n is 3.

10. The chemistry matrix composition of claim 5, wherein Z is —

OY;

Y is —

(CH₂)_nQ;

Q is —

OR²;

R² is Me; and

n is 4.

11. The chemistry matrix composition of claim 5, wherein Z is —

(CH₂)_mCOOH and m is 1.

12. The chemistry matrix composition of claim 5, wherein Z is —

NHAc.

20. The chemistry matrix composition of claim 1 for use in an electrochemical process for determining the concentration of an analyte with reduced interference from other constituents present with the analyte.

21. The chemistry matrix composition of claim 20 in which the 5-alkylphenazine quaternary salt is a 5-ethylphenazine salt.

22. The chemistry matrix composition of claim 21 in which the 5-ethylphenazine salt is 1-(3-carboxypropyloxy)-5-ethylphenazine.

13. A chemistry matrix composition for use in analyzing the concentration of an analyte with reduced interference from other constituents present with the analyte, the composition comprising glucose dehydrogenase;

nicotinamide adenine dinucleotide;

a nitrosoaniline and a 5-alkylphenazine quaternary salt having the formula;

14. The chemistry matrix of claim 13, wherein R¹ is C₂H₅.

15. The chemistry matrix of claim 14, wherein said nitrosoaniline has the formula:

16. The chemistry matrix of claim 15, wherein said nitrosoaniline has the formula:

17. A chemistry matrix composition for use in analyzing the concentration of an analyte, comprising glucose dehydrogenase, nicotinamide adenine dinucleotide, a nitrosoaniline precursor and a photochemically stable 1-carboxyalkyloxy-5-alkylphenazine useful for determining the concentration of an analyte.

18. The chemistry matrix of claim 17, wherein the nitrosoaniline has the formula:

19. The chemistry matrix of claim 18, wherein the 5-alkyl-1-carboxyalkyloxyphenazine is a compound having the formula: