VOLTAMMETRIC SYSTEMS FOR ASSAYING BIOLOGICAL ANALYTES

• US 20170370871A1
• Filed: 09/06/2017
• Published: 12/28/2017
• 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
• Granted Patent: US 10,416,110 B2
• Time in Patent Office: 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

1-22. -22. (canceled)

23. handheld analyte measuring device, for determining the concentration of an analyte in a sample, comprising an acyclic scanning measuring device adapted to receive a sensor strip, where

the acyclic scanning measuring device comprises at least two device contacts in electrical communication with a display through electrical circuitry, and

the sensor strip comprises at least first and second sensor strip 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 comprises an oxidoreductase and at least one species of a redox pair.

24. The device of claim 23, where the analyte is glucose.

25. The device of claim 23, where the first reagent layer is on at least the working and counter electrodes.

26. The device of claim 23, comprising a second reagent layer on at least the counter electrode, the second reagent layer comprising at least one species of a redox pair.

27. The device of claim 23, where the electrical circuitry comprises means for applying an acyclic scan to the sensor strip, where the senor strip contains the sample.

28. The device of claim 23, where the acyclic scanning comprises forward and reverse linear scans where the forward scan starts at a different voltage than where the reverse scan stops.

27-1. The device of claim 23, where the acyclic scan comprises forward and reverse linear scans where the forward scan starts and the reverse scan ends at a point at most ±

20 mV away from a formal potential E°

′

of a redox pair.

28-1. The device of claim 23, where the acyclic scan comprises forward and reverse linear scans within the steady-state region of a redox pair, the scans having a scan range from 10 to 200 mV.

29. A handheld analyte measuring device, for determining the concentration of an analyte in a sample, comprising a voltammetric scanning measuring device adapted to receive a sensor strip, where

the voltammetric scanning measuring device comprises at least two device contacts in electrical communication with a display through electrical circuitry;

and

the sensor strip comprises at least first and second sensor strip 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.

30. The device of claim 29, where the analyte is glucose.

31. The device of claim 29, where the voltammetric scanning comprises a linear scan.

32. The device of claim 29, where the voltammetric scanning comprises a cyclic scan.

33. The device of claim 29, where the first reagent layer is on at least the working and counter electrodes.

34. The device of claim 29, 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.

35. The device of claim 29, where the electrical circuitry comprises means for applying a voltammetric scan to the sensor strip, where the senor strip contains the sample.

36. The device of claim 29, where the means for applying a voltammetric scan to the sensor strip comprises a means for applying a linear scan to the sensor strip.

37. The device of claim 29, where the means for applying a voltammetric scan to the sensor strip comprises a means for applying a cyclic scan to the sensor strip.