Biosensor desiccant system having enhanced measurement performance

• US 9,233,788 B2
• Filed: 07/19/2012
• Issued: 01/12/2016
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Chu, Amy H., Warchal-Windham, Mary Ellen
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/553,203
• Publication Number:
  US 20130186755A1
• Time in Patent Office: 1,272 Days
• US Class Current: 1/1
• CPC Class Codes: B65B 55/00 Preserving, protecting or purifying packages or package contents in association with packaging by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22
• CPC Class Codes: B65D 81/266 for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• 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 33/48778 Containers specially adapted therefor, e.g. for dry storage

Abstract

A biosensor system for determining the concentration of an analyte in a sample includes a plurality of test sensors, and includes a container including a desiccant and the plurality of test sensors, sealed in the container. When the container is stored for two weeks at a temperature of 50° C., and each test sensor is subsequently removed from the container, connected through the at least two conductors to a measurement device and then contacted with one of a plurality of samples including an analyte, where the plurality of samples has analyte concentrations that span the range of 50 mg/dL-600 mg/dL, and the analyte concentration in each sample is determined by the test sensor and the measuring device, the bias of each determined analyte concentration may be within ±10 mg/dL or ±10%, and the coefficient of variation of the determined analyte concentrations may be at most 2.5%.

Claims

1. A biosensor system, for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, where one of the conductors is a working electrode, and

a reagent composition disposed on or near the working electrode; and

a container comprising a desiccant and the plurality of test sensors, sealed in the container, where the desiccant adsorbs at most 15% of its weight in water when in contact with an environment of 10%-20% RH at 40°

C., the desiccant comprising a blend of molecular sieves and silica gel, the container comprising the desiccant retaining an appropriate residual moisture level;

where the appropriate residual moisture level in the container is such that, when the container is stored for two weeks at a temperature of 50°

C., and each test sensor is subsequently removed from the container, connected through the at least two conductors to a measurement device and then contacted with one of a plurality of samples including an analyte, and the analyte concentration in each sample is determined by the test sensor and the measuring device, the plurality of samples having analyte concentrations that span the range of 50 mg/dL-600 mg/dL,

the bias of each determined analyte concentration less than 100 mg/dL is within ±

10 mg/dL, and the bias of each determined analyte concentration of at least 100 mg/dL is within ±

10%.

2. The biosensor system of claim 1, where the bias of each determined analyte concentration less than 100 mg/dL is within ±

7 mg/dL, and the bias of each determined analyte concentration of at least 100 mg/dL is within ±

7%.

3. The biosensor system of claim 1, where the bias of each determined analyte concentration less than 100 mg/dL is within ±

5 mg/dL, and the bias of each determined analyte concentration of at least 100 mg/dL is within ±

5%.

4. The biosensor system of claim 1, where the desiccant adsorbs at most 10% of its weight in water when in contact with an environment of 10%-20% RH at 40°

C.

5. The biosensor system of claim 1, where the desiccant adsorbs from 5%-10% of its weight in water when in contact with an environment of 10%-20% RH at 40°

C.

6. The biosensor system of claim 1, where the container comprises at most 10 mg of the silica gel per test sensor.

7. The biosensor system of claim 1, where the plurality of test sensors comprises at least 50 test sensors.

8. The biosensor system of claim 1, where the plurality of test sensors comprises at least 100 test sensors.

9. The biosensor system of claim 1, wherein the coefficient of variation of the determined analyte concentrations is at most 2.5%.

10. A biosensor system, for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, where one of the conductors is a working electrode, and

a reagent composition disposed on or near the working electrode, the reagent composition comprising a redox enzyme having an activity; and

a container comprising 7.5 to 30 mg per test sensor of a desiccant and the plurality of test sensors, sealed in the container, the desiccant including

a pure molecular sieve desiccant or a polymer-blended molecular sieve, and

silica gel or a polypropylene film coated with silica gel;

where, when the container is stored for two weeks at a temperature of 50°

C., and each test sensor is subsequently removed from the container, the reagent composition of each test sensor retains at least 75% of the activity of the redox enzyme.

11. The biosensor system of claim 10, where the reagent composition of each test sensor retains at least 80% of the activity of the redox enzyme.

12. A biosensor system, for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, where one of the conductors is a working electrode, and

a reagent composition disposed on or near the working electrode; and

a container comprising a desiccant and the plurality of test sensors, sealed in the container, the desiccant including a molecular sieve desiccant and silica gel;

where, when the container is stored for two weeks at a temperature of 50°

C., and each test sensor is subsequently removed from the container, connected through the at least two conductors to a measurement device and then contacted with one of a plurality of samples including an analyte, and the analyte concentration in each sample is determined by the test sensor and the measuring device, the plurality of samples having analyte concentrations that span the range of 100 mg/dL-600 mg/dL, the coefficient of variation of the determined analyte concentrations is at most 2.5%.

13. The biosensor system of claim 12, wherein the desiccant includes about 22.5 mg per test sensor of molecular sieve desiccant.

14. The biosensor system of claim 12, wherein the desiccant includes about 30.0 mg per test sensor of silica gel.

15. A method of increasing the measurement performance of a test sensor, comprising:

sealing the test sensor in a container comprising a desiccant, the desiccant comprising

silica gel and polymer-blended molecular sieves, or

a blend of molecular sieves and silica gel;

the test sensor comprising at least two conductors, one of which is a working electrode, and a reagent composition disposed on or near the working electrode;

where the desiccant adsorbs at most 15% of its weight in water when in contact with an environment of 10%-20% RH at 40°

C.

16. The method of claim 15, wherein the desiccant includes about 5 to about 30 mg of silica gel per test sensor.

17. A biosensor system, for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, where one of the conductors is a working electrode, and

a reagent composition disposed on or near the working electrode; and

a container comprising a desiccant and the plurality of test sensors, sealed in the container, the desiccant comprising silica gel and polymer-blended molecular sieves, or a blend of molecular sieves and silica gel;

where the desiccant adsorbs at most 15% of its weight in water when in contact with an environment of 10%-20% RH at 40°

C.

18. The biosensor system of claim 17, where the desiccant includes at most 10 mg of the silica gel per test sensor.

19. A biosensor system, for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, where one of the conductors is a working electrode, and

a reagent composition, disposed on or near the working electrode, where the reagent composition comprises a redox enzyme having an activity, and is substantially free of a sugar or a sugar alcohol; and

a container comprising 7.5 to 30 mg per test sensor of a desiccant and the plurality of test sensors, sealed in the container, the desiccant including a pure molecular sieve desiccant or a polypropylene film coated with molecular sieves, and silica gel or a polypropylene film coated with silica gel;

where, when the container is stored for two weeks at a temperature of 50°

C., and each test sensor is subsequently removed from the container, the reagent composition of each test sensor retains at least 75% of the activity of the redox enzyme.

20. A biosensor system for determining the concentration of an analyte in a sample, comprising:

a plurality of test sensors, each test sensor comprising

at least two conductors, one of the conductors being a working electrode, and

a reagent composition disposed on or near the working electrode; and

a container comprising desiccant and the plurality of test sensors sealed in the container, the desiccant comprising up to 22.5 mg per test sensor molecular sieves and up to 30 mg per test sensor silica gel, the container comprising the desiccant retaining an appropriate residual moisture level;

where the appropriate residual moisture level in the container is such that, when the container is stored for two weeks at a temperature of 50°

C., the bias of an analyte concentration determined using one of the plurality of test sensors less than 100 mg/dL is within ±

10 mg/dL, and the bias of each determined analyte concentration of 100-600 mg/dL is within ±

10%.