Methods for electrochemical analysis using matrix compositions with alkylphenazine quaternary salt and a nitrosoaniline

• US 8,535,511 B2
• Filed: 08/12/2011
• Issued: 09/17/2013
• 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: Wilsey, Christopher D., Ghoshal, Mitali, Wieder, Herbert
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): RUFO, LOUIS J
• Application Number:
  US13/208,420
• Publication Number:
  US 20110290670A1
• Time in Patent Office: 767 Days
• Field of Search: 205/777.5, 205/792, 204/403.01, 204/403.12, 204/403.14, 204/403.04, 204/403.1
• US Class Current: 205/777.5
• 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 method for determining the concentration of an analyte in a liquid sample with reduced interference from other constituents present with the analyte, which comprises reacting the analyte with a matrix comprising glucose dehydrogenase, nicotinamide adenine dinucleotide, a nitrosoaniline and a 5-alkylphenazine quaternary salt to provide an electro-active agent, wherein said matrix is photochemically stable, measuring an electrochemical response produced by the electro-active agent, and determining the analyte concentration in the liquid sample based on the electrochemical response measured.

2. The method of claim 1, wherein the analyte is glucose and the sample contains from about 20 mg/dL to about 600 mg/dL of blood glucose.

3. The method of claim 1 which comprises applying the sample to an application area of a biosensor having a test strip including the matrix and displaying the concentration on a display of a monitoring device configured for use with said biosensor, wherein said 5 alkylphenazine quaternary salt has the formula:

4. The method of claim 3, wherein said determining can be carried out for said sample having a blood glucose level ranging from about 20 to about 600 mg/dL.

5. The method of claim 3, wherein said displaying occurs within about 5 seconds or less after applying said sample.

6. The method of claim 1 wherein said 5-alkylphenazine quaternary salt has the formula:

7. The method of claim 6, wherein R¹ is C₂H₅.

8. The method of claim 7, wherein said nitrosoaniline has the formula:

9. The method of claim 8, wherein Z is —

OY;

Y is —

(CH₂)_nCOOQ;

Q is OH; and

n=3.

10. The method of claim 8, wherein Z is —

OY;

Y is —

(CH₂)_nCOOQ;

Q is —

NHCH₂CH₂—

(OCH₂CH₂)_o-G;

G is —

COOH; and

o is 4.

11. The method of claim 8, wherein Z is —

OY;

Y is —

(CH₂)_nQ;

Q is —

NH₂ and n is 4.

12. The method of claim 8, wherein Z is —

OY;

Y is —

(CH₂)_n Q;

Q is —

OH and n is 3.

13. The method of claim 8, wherein Z is —

OY;

Y is —

(CH₂)_n Q;

Q is —

OR²;

R² is Me; and

n is 4.

14. The method of claim 8, wherein Z is —

(CH₂)_mCOOH and m is 1.

15. The method of claim 8, wherein Z is —

NHAc.

16. The method of claim 6 in which the 5-alkylphenazine quaternary salt is a 5-ethylphenazine salt.

17. The method of claim 16 in which the 5-ethylphenazine salt is 1-(3-carboxypropyloxy)-5-ethylphenazine.

18. The method of claim 1, wherein the nitrosoaniline is a compound having the formula:

19. The method of claim 18 wherein said nitrosoaniline has the formula:

20. The method of claim 1 in which the 5-alkylphenazine quaternary salt has the formula:

21. The method of claim 20, wherein R¹ is C₂H₅.

22. The method of claim 21, wherein said nitrosoaniline has the formula:

23. The method of claim 22, wherein said nitrosoaniline has the formula:

24. A method for determining the concentration of an analyte in a liquid sample with reduced interference from other constituents present with the analyte, which comprises reacting the analyte with a matrix comprising glucose dehydrogenase, nicotinamide adenine dinucleotide, a nitrosoaniline and a photochemically stable 1-carboxyalkyloxy-5-alklyphenazine to provide an electro-active agent, wherein said matrix is photochemically stable, measuring an electrochemical response produced by the electro-active agent, and determining the analyte concentration in the liquid sample based on the electrochemical response measured.

25. The method of claim 24, wherein the nitrosoaniline has the formula:

26. The method of claim 25, wherein the 5-alkyl-1-carboxyalkyloxyphenazine is a compound having the formula: