Porous particle reagent compositions

• US 8,252,523 B2
• Filed: 12/10/2008
• Issued: 08/28/2012
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Zhu, Boru
• Primary Examiner(s): Lankford, Jr., Blaine
• Assistant Examiner(s): CONSTANTINE, CHARLES Z
• Application Number:
  US12/331,817
• Publication Number:
  US 20090178936A1
• Time in Patent Office: 1,357 Days
• Field of Search: 435/4, 435/14, 435/176, 204/403.14, 205/777.5
• US Class Current: 435/4
• 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 reagent composition, for determining the concentration of an analyte in a sample, comprising:

about 1% to about 30% (w/w) of an about 20% to an about 50% (w/w) suspension of porous particles, the particles having an average diameter from 0.05 micrometer to 10 micrometer and a void volume of at least 20% (v/v);

about 0.1% to about 10% (w/w) of at least one polymeric material; and

about 0.1 active units to about 10 active units of at least one enzyme system per microliter of the reagent composition.

2. The composition of claim 1, further comprising from about 0.5% to about 10% (w/w) of at least one mediator.

3. The composition of claim 2, where the at least one mediator comprises a one electron transfer mediator, and the composition comprises from about 1.5% to about 2.5% (w/w) of the one electron transfer mediator.

4. The composition of claim 2, where the at least one mediator comprises a two electron transfer mediator.

5. The composition of claim 1, further comprising from about 0.01% to about 1% (w/w) of at least one surfactant.

6. The composition of claim 5, where the at least one surfactant comprises a saccharide based surfactant or an ethoxylate based neutral surfactant.

7. The composition of claim 1, the porous particles having an average pore volume from about 0.5 to about 1 milliliter per gram.

8. The composition of claim 7, where at least about 0.5 cubic centimeter per gram of the pore volume is from pores having a pore size of at most 600 angstroms.

9. The composition of claim 7, where at least 80% of the pore volume is from pores having pore sizes less than 300 angstroms.

10. The composition of claim 1, the porous particles having an average surface area from about 100 to about 200 meter² per gram.

11. The composition of claim 1, the porous particles formed from silica and having an anionic surface charge in water.

12. The composition of claim 1 having a pH from about 4.5 to about 7.5.

13. The composition of claim 1, further comprising at least one carrier liquid, where the composition is a colloidal suspension.

14. The composition of claim 13, where the colloidal suspension is stabilized against flocculation.

15. The composition of claim 1, comprising about 2% to about 15% (w/w) of an about 20% to an about 35% (w/w) suspension of porous particles,

the particles having an average diameter from 0.1 micrometer to 5 micrometer and a void volume of at least 40% (v/v).

16. The composition of claim 1, comprising about 4% to about 8% (w/w) of an about 23% to an about 28% (w/w) suspension of porous particles,

the particles having an average diameter from 0.1 micrometer to 0.5 micrometer and a void volume of at least 65% (v/v).

17. The composition of claim 1, the porous particles having an average surface area from about 155 to about 175 meter² per gram.

18. The composition of claim 1, the porous particles having pores that exclude the enzyme system and the polymeric material.

19. The composition of claim 18, the porous particles having pore sizes less than about 5 nanometers.

20. The composition of claim 1, where the at least one polymeric material comprises a substantially water soluble polymeric material, and the composition comprises from about 1% to about 1.5% (w/w) of the substantially water soluble polymeric material.