Matrix Stability Compositions, Test Elements, Test Systems and Methods of Use Thereof

• US 20150177178A1
• Filed: 03/05/2015
• Published: 06/25/2015
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Lica, Georgeta C., DuVall, Stacy H., Kachel, Sibylle, Schabel, Wilhelm, Scharfer, Philip
• Granted Patent: US 9,459,230 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

Reagent matrices and methods are disclosed for improving the stability of test elements with respect to degradation by humidity in the air. The reagent matrices and methods are based upon using an effective amount of a deliquescent material to decrease the sorption of water from the air by other components of a reagent matrix. When the test element is a glucose-specific test strip, and the reagent matrix can include a glucose dehydrogenase enzyme and/or a flavin adenine dinucleotide cofactor, a nitrosoaniline mediator, and a film former, where the deliquescent material may include a salt such as sodium chloride in an amount effective to absorb water from the atmosphere at a rate that is faster than the rate at which the other components of the reagent matrix absorb water from the atmosphere.

Claims

1. A test element for determining a presence or a concentration of an analyte in a sample fluid, comprising:

at least one working electrode and at least one counter electrode disposed upon a substrate; and

a dry-film reagent matrix extending between the at least one working electrode and the at least one counter electrode and configured for an electrode reaction, wherein the dry-film reagent matrix comprises a deliquescent material and one or more active ingredients effective for facilitating a desired electrochemical reaction, wherein the deliquescent material is present in an amount effective to preemptively absorb water from the atmosphere when the relative humidity exceeds a predetermined level, and wherein the deliquescent material has a deliquescence point between about 50% relative humidity and about 80% relative humidity.

2. The test element of claim 1, wherein the deliquescent material has a deliquescence point at about 75% relative humidity.

3. The test element of claim 1, wherein the deliquescent material comprises one or more members selected from the group consisting of sodium chloride, calcium chloride, magnesium chloride, magnesium sulfate, zinc chloride, potassium carbonate, potassium phosphate, carnallite, ferric ammonium citrate, potassium hydroxide, and sodium hydroxide.

4. The test element of claim 3, wherein the deliquescent material is sodium chloride, magnesium sulfate, or a combination thereof.

5. The test element of claim 1, wherein the test element is a glucose-specific test strip, wherein the one or more active ingredients effective for facilitating the desired electrochemical reaction is a glucose reagent matrix comprising at least one enzyme system and at least one mediator.

6. The test element of claim 5, wherein the at least one enzyme system comprises a glucose dehydrogenase and a flavin adenine dinucleotide cofactor.

7. The test element of claim 5, wherein the at least one mediator comprises a nitrosoaniline.

8. The test element of claim 1, wherein the dry-film reagent matrix further comprises a film former comprising a polyvinylpyrrolidone (PVP) and/or a PVP-containing material.

9. The test element of claim 1, wherein the deliquescent material absorbs water from the atmosphere at a rate that is faster than a rate at which the other components of the reagent matrix absorb water from the atmosphere when the relative humidity in the atmosphere exceeds about 75%.

10. The test element of claim 1, wherein the deliquescent material absorbs water from the atmosphere at a rate that is faster than a rate at which the other components of the reagent matrix absorb water from the atmosphere when the relative humidity exceeds the deliquescence point of the deliquescent material.

11. The test element of claim 1, wherein the deliquescent material is in an amount from about 1% to about 10% by weight percent based on the total weight of the dry-film reagent matrix.

12. The test element of claim 1, wherein the deliquescent material is in an amount of at least about 2% by weight percent based on the total weight of the dry-film reagent matrix.

13. The test element of claim 1, wherein the deliquescent material is sodium chloride and is provided in an amount between about 3.0% by weight percent and about 6.0% by weight percent in the dry-film reagent matrix based on the total weight of the dry-film reagent matrix.

14. The test element of claim 1, wherein the deliquescent material is magnesium sulfate and is provided in an amount between about 3.0% by weight percent and about 7.0% by weight percent in the dry-film reagent matrix based on the total weight of the dry-film reagent matrix.

15. A method of improving stability of a test element with respect to degradation of reagent components by humidity in air, the method comprising the step of:

providing a test element comprising at least one working electrode and at least one counter electrode disposed on a substrate, and a dry-film reagent matrix extending between the at least one working electrode and the at least one counter electrode, wherein the dry-film reagent matrix comprises a deliquescent material in an amount effective to decrease the sorption of water from the air by other reagent components of the dry-film reagent matrix.

16. The method of claim 15, wherein the deliquescent material is sodium chloride and is provided in an amount between about 3.0% by weight percent and about 6.0% by weight percent in the dry-film reagent matrix based on the total weight of the dry-film reagent matrix.

17. The method of claim 15, wherein the deliquescent material is magnesium sulfate and is provided in an amount between about 3.0% by weight percent and about 7.0% by weight percent in the dry-film reagent matrix based on the total weight of the dry-film reagent matrix.