IP Library Granted Patent US 10,696,998
Granted Patent B2
US 10,696,998 · App. 15/682,182 · Granted Jun 30, 2020

Reagents and methods for detecting analytes

Inventors: Amy H. Chu (Elkhart, IN); Karen L. Marfurt (Edwardsburg, MI); Brenda L. Tudor (Elkhart, IN); Mary Ellen Warchal-Windham (Osceola, IN); Boru Zhu (Granger, IN)
Assignee: ASCENSIA DIABETES CARE HOLDINGS AG
C12Q1/004C12Q1/005G01N27/3271
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Quick Facts
Patent No.
US 10,696,998
App. No.
15/682,182
Granted
Jun 30, 2020
Kind
B2
Abstract

A reagent for detecting an analyte comprises a flavoprotein enzyme, a mediator such as a phenothiazine mediator, at least one surfactant, a polymer and a buffer. The reagent may be used with an electrochemical test sensor that includes a plurality of electrodes.

Claims (11)

1. An electrochemical test sensor comprising:

a working electrode having a surface;

a counter electrode having a surface; and

a reagent coating at least a portion of the surface of the working electrode and at least a portion of the surface of the counter electrode, the reagent comprising FAD-glucose dehydrogenase, a 3-(2′,5′-disulfophenylimino)-3H-phenothiazine mediator having about 5 wt. % sulfate, a phosphate buffer, a surfactant, and a hydroxyethyl cellulose polymer, wherein at least one of the mediator and the buffer includes an inorganic salt, and a ratio of the total inorganic salt to mediator is less than about 3:1.

2. The sensor of claim 1 , wherein the ratio of the total inorganic salt to mediator is in a ratio of less than about 2:1.

3. The test sensor of claim 1 , wherein the reagent includes about 2.00 U/μL of the FAD-glucose dehydrogenase enzyme, about 40 mM of the 3-(2′,5′-disulfophenylimino)-3H-phenothiazine enzyme, about 50 mM of the buffer, about 0.20 wt. % of heptanoyl-N-methylglucamide surfactant, and about 0.25 wt. % of the hydroxyethyl cellulose polymer.

4. The test sensor of claim 1 , wherein the buffer is a phosphate buffer, the reagent including about 30 mM of the phosphate buffer.

5. The test sensor of claim 1 , wherein the FAD-glucose dehydrogenase has an activity of from about 0.5 Units/μL to about 2.5 Units/μL, the 3-(2′,5′-disulfophenylimino)-3H-phenothiazine mediator has a concentration of from about 30 mM to about 60 mM, the surfactant being a heptanoyl-N-methylglucamide surfactant having a concentration of from about 0.1 wt. % to about 0.4 wt. % of the reagent, and the hydroxyethyl cellulose polymer has a concentration of from about 0.2 wt. % to about 0.5 wt. % of the reagent.

6. The test sensor of claim 1 , wherein the FAD-glucose dehydrogenase has an activity of about 1.75 Units/μL, the 3-(2′,5′-disulfophenylimino)-3H-phenothiazine mediator has a concentration of about 40 mM, the surfactant having a concentration of about 0.2 wt. %, the hydroxyethyl cellulose has a concentration of about 0.25 wt. %, and the buffer being a phosphate buffer having a concentration of about 100 mM.

7. The test sensor of claim 6 , wherein the coefficient of variation of the reagent is between about 1.2 and about 3.4.

8. The test sensor of claim 1 , wherein the buffer is a phosphate buffer, the reagent including about 50 mM of the phosphate buffer at a pH of about 6.5, about 0.25% of the hydroxyethyl cellulose polymer, about 0.2% of heptanoyl-N-methylglucamide surfactant, and about 40 mM of the 3-(2′,5′-disulfophenylimino)-3H-phenothiazine mediator, wherein the FAD-glucose dehydrogenase has an activity of about 2 Units/μL, and wherein the coefficient of variation of the reagent is between about 1.4 and about 2.7.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2017
From: CHU, AMY; MARFURT, KAREN L; TUDOR, BRENDA; WARCHAL-WINDHAM, MARY ELLEN; ZHU, BORU
To: BAYER HEALTHCARE, LLC
Reel/Frame 044347/0736 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2017
From: BAYER HEALTHCARE, LLC
To: ASCENSIA DIABETES CARE HOLDINGS AG
Reel/Frame 044347/0748 →