Porous particle reagent compositions, devices, and methods for biosensors

• US 8,617,835 B2
• Filed: 07/23/2012
• Issued: 12/31/2013
• 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): Weber, Jon P
• Assistant Examiner(s): CONSTANTINE, CHARLES Z
• Application Number:
  US13/555,421
• Publication Number:
  US 20120305410A1
• Time in Patent Office: 526 Days
• Field of Search: None
• US Class Current: 435/14
• 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. An electrode for a biosensor, comprising:

at least one conductor; and

at least one reagent composition disposed on the conductor, the reagent composition comprising;

porous particles having an average diameter from 0.05 micrometer to 10 micrometer and a void volume of at least 20% (v/v);

from about 0.5% to about 10% (w/w) of at least one mediator;

at least one polymeric material; and

at least one enzyme system.

2. The electrode of claim 1, where the reagent composition is formed from drying water from a colloidal suspension of the reagent composition.

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

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

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

6. A biosensor sensor strip, for determining the concentration of an analyte in a sample, comprising:

a sensor base at least partially covered by a lid;

at least one reservoir formed by the sensor base, where the at least one reservoir encloses at least two conductors disposed on the base; and

at least one reagent composition on at least one of the conductors to form a working electrode, the at least one reagent composition comprising,

porous 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 active unit to about 10 active units of at least one enzyme system per microliter of the at least one reagent composition,

about 0.5% to about 10% (w/w) of at least one mediator, and

at least one polymeric material;

where the reservoir and the at least one reagent composition provide a maximum kinetic performance of a redox reaction of an analyte with the at least one reagent composition within less than about three seconds of introducing a sample to the sensor strip; and

where the maximum kinetic performance is determined with a gated amperometric pulse sequence having at least five duty cycles, where

each excitation of the duty cycles is 0.4 second in duration,

each relaxation of the duty cycles is one second in duration,

the relaxations are provided by an open circuit,

at least three output current values are measured during each excitation,

the excitations have a substantially constant potential of 250 mV, and

the sample temperature is 23°

C.

7. The strip of claim 6, where the maximum kinetic performance of the redox reaction of the analyte with the at least one reagent composition is provided within from about 2 to about 2.5 seconds of introducing the sample to the sensor strip.

8. The strip of claim 6, where the maximum kinetic performance is reached when an initial current value obtained from an excitation having decaying current values is the greatest initial current value obtained from the at least five duty cycles.

9. The strip of claim 6, where the maximum kinetic performance is reached when a last in time current value obtained from an excitation having decaying current values is the greatest last in time current value obtained from the at least five duty cycles.

10. The strip of claim 6, where the maximum kinetic performance is reached during a time period from when an initial current value obtained from an excitation having decaying current values is the greatest initial current value obtained from the at least five duty cycles to when a last in time current value obtained from the same excitation is the greatest last in time current value obtained from the at least five duty cycles.

11. The strip of claim 6, where the analyte comprises glucose, where the sample comprises whole blood, and where the maximum kinetic performance of the redox reaction occurs within substantially the same time of introducing the sample to the sensor strip for glucose concentrations of from 100 mg/dL to 300 mg/dL in the sample.

12. The strip of claim 6, the reagent composition further comprising from about 0.01% to about 1% (w/w) of at least one surfactant.

13. The strip of claim 6, the porous particles having an average pore volume from about 0.5 to about 1 milliliter per gram.

14. The strip of claim 6, the porous particles having an average surface area from about 100 to about 200 meter² per gram.

15. A method of determining the concentration of a biological analyte, comprising:

introducing an aqueous sample including at least one biological analyte to a an electrode, the electrode comprising;

at least one conductor; and

at least one reagent composition disposed on the conductor, the reagent composition comprising;

porous particles having an average diameter from 0.05 micrometer to 10 micrometer and a void volume of at least 20% (v/v);

from about 0.5% to about 10% (w/w) of at least one mediator;

at least one polymeric material; and

at least one enzyme system;

rehydrating the reagent composition with the aqueous sample;

applying an input signal to the aqueous sample;

measuring at least one output signal current value within about 0.4 to about 5 seconds of introducing the aqueous sample to the reagent composition; and

determining the concentration of the at least one analyte in the aqueous sample from the at least one output signal current value.

16. The method of claim 15, comprising measuring the at least one output signal current value within about 1.7 to about 2.7 seconds of introducing the aqueous sample to the reagent composition.

17. The method of claim 15, where the analyte comprises glucose, where the aqueous sample comprises whole blood, where at least two output signal current values are determined at sample glucose concentrations between about 50 mg/dL to about 550 mg/dL, and where the at least two output signal current values when correlated with reference glucose concentration values have a R² linearity value of at least 0.90.

18. The method of claim 15, further comprising measuring the at least one output signal current value during a maximum kinetic performance of a redox reaction between the reagent composition and the at least one analyte, where the maximum kinetic performance is determined with a gated amperometric pulse sequence having at least five duty cycles, and where

each excitation of the duty cycles is 0.4 seconds in duration,

each relaxation of the duty cycles is one second in duration,

the relaxations are provided by an open circuit,

at least three output current values are measured during each excitation,

the excitations have a substantially constant potential of 250 mV, and

the sample temperature is 23°

C.

19. The method of claim 18, comprising measuring the at least one output signal current value within about 1.7 to about 2.7 seconds of introducing the aqueous sample to the reagent composition.

20. The method of claim 18, further comprising measuring the at least one output signal current value during a current decay.

21. The method of claim 15, the porous particles having an average pore volume from about 0.5 to about 1 milliliter per gram.

22. The method of claim 15, the porous particles having an average surface area from about 100 to about 200 meter² per gram.

23. The method of claim 15, further comprising outputting a determined concentration of the at least one analyte to a display within at most five seconds.

24. The method of claim 15, further comprising outputting a determined concentration of the at least one analyte to a display within at most three seconds.