Biosensors and porous particle reagent compositions

• US 9,382,573 B2
• Filed: 12/02/2013
• Issued: 07/05/2016
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Zhu, Boru
• Primary Examiner(s): Yamasaki, Robert
• Assistant Examiner(s): CONSTANTINE, CHARLES Z
• Application Number:
  US14/094,032
• Publication Number:
  US 20140154718A1
• Time in Patent Office: 946 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: C12N 11/14 Enzymes or microbial cells immobilised on or in an inorganic carrier
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• 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 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A reagent composition for a biosensor sensor strip is disclosed that provides for rapid rehydration after drying. The composition includes porous particles and is preferably formed as a colloidal suspension. The dried reagent composition including porous particles may provide analytically useful output from the sensor strip in a shorter time period than observed from dried reagent compositions using solid particles. The output signal from the porous particle compositions may be correlated to the analyte concentration of a sample within about two seconds. In this manner, an accurate concentration determination of an analyte concentration in a sample may be obtained in less time than from sensor strips including conventional compositions. The reagent composition including the porous particles also may allow for the redox reaction between the reagents and the analyte to reach a maximum kinetic performance in a shorter time period than observed from conventional sensor strips.

Claims

1. A test sensor to assist in determining information of an analyte in a fluid sample, the test sensor comprising:

a base including a reagent composition, the reagent composition including porous particles with a plurality of pores, the porous particles having an average diameter from 0.05 to 10 micrometers (μ

m) and a void volume of at least 20% (v/v), an electron transfer mediator, a polymeric material, and an enzyme; and

a second layer, the second layer and the base assisting in forming an opening for receiving the fluid sample.

2. The test sensor of claim 1, wherein the porous particles have an average diameter from 0.1 to 5 micrometers (μ

m).

3. The test sensor of claim 1, wherein the porous particles have an average surface area from about 100 to about 200 m²/g.

4. The test sensor of claim 3, wherein the porous particles have an average surface area from about 155 to about 175 m²/g.

5. The test sensor of claim 1, wherein the porous particles have a void volume of at least 40% (v/v).

6. The test sensor of claim 5, wherein the porous particles have a void volume of at least 65% (v/v).

7. The test sensor of claim 1, wherein at least about 0.5 cc/g of the pore volume is from pores having a pore size of at most 600 angstroms.

8. The test sensor of claim 1, wherein at least 80% of the pore volume is from pores having pore sizes less than 300 angstroms.

9. The test sensor of claim 1, wherein the plurality of pores is sized to exclude the at least one enzyme and the at least one polymeric material.

10. The test sensor of claim 1, wherein the plurality of pores is less than about 5 nanometers.

11. The test sensor of claim 1, wherein the porous particles comprise silica.

12. The test sensor of claim 11, wherein the porous particles have an anionic surface charge in water.

13. The test sensor of claim 1, wherein the porous particles comprise zeolite.

14. The test sensor of claim 1, wherein the reagent composition includes from about 0.5 to about 10% (w/w) of the mediator.

15. The test sensor of claim 14, wherein the reagent composition includes from about 0.8 to about 3% (w/w) of the mediator.

16. The test sensor of claim 1, wherein the reagent composition comprises from about 0.1 to about 10% (w/w) of the polymeric material.

17. The test sensor of claim 16, wherein the reagent composition comprises from about 0.8 to about 3% (w/w) of the polymeric material.

18. The test sensor of claim 1, wherein the enzyme is glucose dehydrogenase.

19. The test sensor of claim 1, wherein the enzyme is glucose oxidase.

20. The test sensor of claim 1, wherein the enzyme includes from about 0.1 active unit to about 10 active units.

21. The test sensor of claim 1, wherein the reagent composition further includes from about 0.01 to about 1% (w/w) of a surfactant.

22. The test sensor of claim 21, wherein the surfactant comprises a saccharide-based surfactant or an ethoxylate-based neutral surfactant.

23. The test sensor of claim 1, wherein the second layer is a lid.

24. The test sensor of claim 1, wherein the base further includes at least one electrode.

25. A test sensor to assist in determining information of an analyte in a fluid sample, the test sensor comprising:

a base including a reagent composition, the reagent composition including porous particles having a plurality of pores, the porous particles having an average diameter from 0.05 to 5 micrometers (μ

m) and a void volume of at least 20% (v/v), from about 0.5 to about 10% (w/w) of an electron transfer mediator, from about 0.1 to about 10% (w/w) of a polymeric material, and an enzyme, the enzyme being glucose dehydrogenase or glucose oxidase; and

a second layer, the second layer and the base assisting in forming an opening for receiving the fluid sample.