Voltammetric Systems for Assaying Biological Analytes

• US 20150083591A1
• Filed: 09/24/2014
• Published: 03/26/2015
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping
• Granted Patent: US 9,784,706 B2
• Time in Patent Office: Days
• US Class Current: 204/403.04
• 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 measuring device, for determining the concentration of an analyte in a sample, comprising:

contacts; and

electronic circuitry in electrical communication with the contacts, the electronic circuitry comprising;

an electric charger and a processor in electrical communication,

the processor in electrical communication with a computer readable storage medium;

where the processor is programmed to measure current from the contacts, and

the computer readable storage medium comprises computer readable software code, which when executed by the processor, determines the concentration of the analyte in the sample from the current measured from the contacts;

where the computer readable software code, when executed by the processor, causes the electric charger to apply a voltammetric scan through the contacts, and causes the processor to implement a data treatment to the current measured from the contacts,

the data treatment selected from the group consisting of a semi-integral data treatment, a derivative data treatment, a semi-derivative data treatment, and combinations thereof.

2. The device of claim 1, where the analyte is selected from the group consisting of glucose, cholesterol, triglycerides, lactate, pyruvate, alcohol, bilirubin, uric acid, NAD(P)H, and carbon monoxide.

3. The device of claim 1, where the computer readable software code, when executed by the processor, causes the electric charger to apply a voltammetric forward linear scan through the contacts.

4. The device of claim 1, where the data treatment comprises a semi-integral data treatment comprising semi-integrating a measured current and determining a steady-state semi-integral current.

5. The device of claim 1, where the data treatment comprises a semi-integral data treatment that separates at least one steady-state current from at least one hematocrit-affected equilibrium current.

6. The device of claim 1, where the data treatment comprises a semi-integral data treatment comprising at least one half-step integration.

7. The device of claim 1, where the data treatment comprises a semi-integral data treatment that lacks a time-dependence factor.

8. The device of claim 1, where the data treatment comprises a semi-integral data treatment and comprises a hematocrit compensation comprising determining a ratio of a peak current value to a steady-state current value.

9. The device of claim 1, where the data treatment comprises a derivative data treatment comprising a hematocrit compensation, where the hematocrit compensation comprises dividing a negative peak by a positive peak.

10. The device of claim 1, where the data treatment comprises a semi-derivative data treatment that transforms at least a portion of a voltammetric current region into a peak.

11. A measuring device, for determining the concentration of an analyte in a sample, comprising:

contacts; and

electronic circuitry in electrical communication with the contacts;

the electronic circuitry comprising

an electric charger and a processor in electrical communication, the processor in electrical communication with a computer readable storage medium;

where the processor is programmed to measure current from the contacts, and

the computer readable storage medium comprises computer readable software code, which when executed by the processor, causes the electric charger to apply a voltammetric forward linear scan through the contacts and the processor to determine the concentration of the analyte in the sample from the current measured from the contacts.

12. The device of claim 11, where the computer readable software code, when executed by the processor, further causes the electric charger to apply a voltammetric reverse linear scan through the contacts at a reversing point of the forward linear scan.

13. The device of claim 12, where the voltammetric forward and reverse linear scans comprise an acyclic scan.

14. The device of claim 12, where the voltammetric forward and reverse linear scans comprise a cyclic scan.

15. The device of claim 12, where the reverse linear scan is within a steady-state region and has a scan range from 10 to 200 mV.

16. The device of claim 12, where the reversing point is selected to provide from 25 to 400 mV of steady-state region, the steady-state region of the scan comprising a change in electrochemical current with respect to voltage of at most ±

10%.

17. The device of claim 12, where the reverse linear scan terminates at a potential from 50 to 500 mV negative from the reversing point.

18. The device of claim 12, where the reverse scan terminates when the current of the reverse scan deviates by at least 25% from a steady-state current.

19. The device of claim 11, where the forward scan comprises at least one voltage providing at least a 100:

1 concentration ratio between two species of a redox pair.

20. The device of claim 11, where the analyte is selected from the group consisting of glucose, cholesterol, triglycerides, lactate, pyruvate, alcohol, bilirubin, uric acid, NAD(P)H, and carbon monoxide.

21. The device of claim 11, further comprising a sensor strip comprising first and second sensor strip contacts in electrical communication with the contacts,

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

the second sensor strip contact in electrical communication with a counter electrode through conductors,

where a first reagent layer is on at least one of the electrodes, the first reagent layer comprising an oxidoreductase and at least one species of a redox pair.

22. The device of claim 21, the sensor strip further comprising

a second reagent layer on the counter electrode, the second reagent layer comprising at least one species of a redox pair,

where the first reagent layer is on the working electrode.