Voltammetric systems for assaying biological analytes

• US 10,416,110 B2
• Filed: 09/06/2017
• Issued: 09/17/2019
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wu, Huan-Ping
• Primary Examiner(s): Noguerola, Alexander S
• Application Number:
  US15/696,402
• Publication Number:
  US 20170370871A1
• Time in Patent Office: 741 Days
• 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 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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 27/48 using polarography, i.e. measuring changes in current under a slowly-varying voltage
• CPC Class Codes: G01N 27/49 Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species

Abstract

The present invention relates to systems, methods, and devices for determining the concentration of an analyte in a sample. The use of linear, cyclic, or acyclic voltammetric scans and/or semi-integral, derivative, or semi-derivative data treatment may provide for increased accuracy when determining the concentration of an analyte in a sample. Hematocrit compensation in combination with the data treatments may reduce the hematocrit effect with regard to a glucose analysis in whole blood. In another aspect, fast scan rates may reduce the hematocrit effect.

Claims

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

a measuring device including at least two device contacts in electrical communication with a display through electrical circuitry, the measuring device being configured to apply an acyclic scan to the sample; and

a sensor strip receivable by the measuring device, the sensor strip including;

a first sensor strip contact;

a second sensor strip contact;

a working electrode in electrical communication with the first sensor strip contact;

a counter electrode in electrical communication with the second sensor strip contact; and

a first reagent layer on (i) the working electrode, (ii) the counter electrode, or (iii) both the working electrode and the counter electrode, the first reagent layer including an oxidoreductase and at least one species of a redox pair.

2. The system of claim 1, wherein the analyte is glucose.

3. The system of claim 1, wherein the first reagent layer is on both the working electrode and the counter electrode.

4. The system of claim 1, wherein the sensor strip further includes a second reagent layer on at least the counter electrode, the second reagent layer including at least one species of a redox pair.

5. The system of claim 1, wherein the electrical circuitry includes a charger configured to apply the acyclic scan to the sensor strip, and wherein the sensor strip contains the sample.

6. The system of claim 1, wherein the acyclic scanning comprises forward and reverse linear scans, the forward scan starting at a different voltage than where the reverse scan stops.

7. The system of claim 1, wherein the acyclic scan includes forward and reverse linear scans, the forward scan starting and the reverse scan ending at a point at most ±

20 mV away from a formal potential E°

′

of a redox pair.

8. The system of claim 1, wherein the acyclic scan includes forward and reverse linear scans within the steady-state region of a redox pair, the forward and reverse scans having a scan range from 10 to 200 mV.

9. A system for determining a concentration of an analyte in a sample, comprising:

a measuring device including

at least two device contacts in electrical communication with a display through electrical circuitry, the measuring device being configured to apply a voltammetric scan to the sample; and

a sensor strip receivable by the measuring device, the sensor strip including;

a first sensor strip contact;

a second sensor strip contact;

a working electrode in electrical communication with the first sensor strip contact;

a counter electrode in electrical communication with the second sensor strip contact; and

a first reagent layer on (i) the working electrode, the (ii) the counter electrode, or (iii) both the working electrode and the counter electrode, the first reagent layer including an oxidoreductase and at least one species of a redox pair.

10. The system of claim 9, wherein the analyte is glucose.

11. The system of claim 9, wherein the voltammetric scan includes a linear scan.

12. The system of claim 9, wherein the voltammetric scan includes a cyclic scan.

13. The system of claim 9, wherein the first reagent layer is on both the working electrode and the counter electrode.

14. The system of claim 9, wherein the first reagent layer is on the working electrode, and wherein the sensor strip further includes a second reagent layer on the counter electrode, the second reagent layer including at least one species of a redox pair.

15. The system of claim 9, wherein the electrical circuitry includes a charger configured to apply the voltammetric scan to the sensor strip, and wherein the sensor strip contains the sample.

16. The system of claim 9, wherein the charger is configured to apply a linear scan to the sensor strip.

17. The system of claim 9, wherein the charger is configured to apply a cyclic scan to the sensor strip.