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WO2005114164B1 - Voltammetric systems for assaying biological analytes - Google Patents

Voltammetric systems for assaying biological analytes

Info

Publication number
WO2005114164B1
WO2005114164B1 PCT/US2005/017009 US2005017009W WO2005114164B1 WO 2005114164 B1 WO2005114164 B1 WO 2005114164B1 US 2005017009 W US2005017009 W US 2005017009W WO 2005114164 B1 WO2005114164 B1 WO 2005114164B1
Authority
WO
WIPO (PCT)
Prior art keywords
scan
semi
determining
acyclic
data treatment
Prior art date
Application number
PCT/US2005/017009
Other languages
French (fr)
Other versions
WO2005114164A3 (en
WO2005114164A2 (en
Filing date
Publication date
Priority to JP2007513447A priority Critical patent/JP4773428B2/en
Priority to US11/596,309 priority patent/US8287717B2/en
Priority to CN200580022790.2A priority patent/CN1981192B/en
Priority to KR1020147002795A priority patent/KR101427559B1/en
Priority to CA2566492A priority patent/CA2566492C/en
Priority to AU2005246314A priority patent/AU2005246314B2/en
Priority to MXPA06013232A priority patent/MXPA06013232A/en
Priority to KR1020127020371A priority patent/KR101440704B1/en
Priority to KR1020067026353A priority patent/KR101328856B1/en
Priority to EP05749689A priority patent/EP1751533A2/en
Priority to BRPI0511098-0A priority patent/BRPI0511098A/en
Application filed filed Critical
Publication of WO2005114164A2 publication Critical patent/WO2005114164A2/en
Publication of WO2005114164A3 publication Critical patent/WO2005114164A3/en
Publication of WO2005114164B1 publication Critical patent/WO2005114164B1/en
Priority to NO20065711A priority patent/NO20065711L/en
Priority to AU2009202915A priority patent/AU2009202915B2/en
Priority to US13/611,557 priority patent/US8871079B2/en
Priority to US14/495,556 priority patent/US9784706B2/en
Priority to US15/696,402 priority patent/US10416110B2/en
Priority to US16/529,539 priority patent/US20190353609A1/en

Links

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

AMENDED CLAIMS received by the International Bureau on 30 December 2005 (30.12.05). Original claims 1-87 have been replaced by amended claims 1-87 (13 pages).
1 . A method of determining the concentration of an analyte in a sample, comprising: applying an acyclic scan to the sample; and determining the concentration of the analyte in the sample.
2. The method 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 method of any of the preceding claims, where the analyte is glucose.
4. The method of any of the preceding claims, where the sample is a biological sample.
5. The method of any of the preceding claims, where the sample is whole blood.
6. The method of any of the preceding claims, where the acyclic scan comprises forward and reverse linear scans where the forward scan starts at a different voltage than where the reverse scan ends.
7. The method of any of the preceding claims, where the acyclic scan comprises forward and reverse linear scans where the forward scan startsand the reverse scan ends at a point at most ±20 mV away from a formal potential E°' of a redox pair.
8. The method of any of the preceding claims, where the acyclic scan comprises forward and reverse linear scans within the steady-
50 state region of a redox pair, the scans having a scan range from 10 to 200 mV.
9. The method of any of the preceding claims, where the acyclic scan comprises changing the voltage of the scan at a rate of at least 176 mV/second.
10. The method of any of the preceding claims, where the acyclic scan comprises changing the voltage of the scan at a rate of at least 500 mV/second.
1 1 . The method of any of the preceding claims, where the acyclic scan comprises changing the voltage of the scan at a rate of at most 1 75 mV/second.
12. The method of any of the preceding claims, where the acyclic scan comprises changing the voltage of the scan at a rate of at most 50 mV/second.
13. The method of any of the preceding claims, where the acyclic scan comprises a scan range from 400 to 600 mV.
14. The method of any of the preceding claims, where the acyclic scan comprises a scan range from 600 to 1000 mV.
15. The method of any of the preceding claims, where the acyclic scan comprises at least 25 mV of steady-state region.
16. The method of any of the preceding claims, where the steady-state region of the scan comprises a change in electrochemical current with respect to voltage of at most ±10 %.
51
17. The method of any of the preceding claims, where the acyclic scan comprises a reversing point selected to provide from 25 to 400 mV of steady-state region.
18. The method of any of the preceding claims, where the acyclic scan comprises a reverse scan terminating at a potential from 50 to
500 mV negative from a reversing point.
19. The method of any of the preceding claims, where the acyclic scan comprises a reverse scan terminating when the current of the reverse scan deviates by at least 25% from a steady-state current.
20. The method of any of the preceding claims, where the acyclic scan comprises at least one voltage providing at least a 100:1 concentration ratio between two species of a redox pair.
21 . The method of any of the preceding claims, where the acyclic scan comprises at least one potential at a working electrode of at least 18O mV.
22. The method of any of the preceding claims, where the determining comprises a semi-integral data treatment.
23. The method of any of the preceding claims, where the semi- integral data treatment comprises semi-integrating current values from the acyclic scan and determining a steady-state semi-integral current.
24. The method of any of the preceding claims, where the semi- integral data treatment separates at least one steady-state current from at least one hematocrit-affected equilibrium current.
52
25. The method of any of the preceding claims, where the semi- integral comprises at least one half-step integration.
26. The method of any of the preceding claims, where the semi- integral data treatment lacks a time-dependence factor.
27. The method of any of the preceding claims, where the determining comprises hematocrit compensation comprising determining a ratio of a peak current value to a steady-state current value.
28. The method of any of the preceding claims, where the determining comprises a derivative data treatment.
29. The method of any of the preceding claims, where the determining comprises hematocrit compensation comprising dividing a negative peak by a positive peak.
30. The method of any of the preceding claims, where the determining comprises a semi-derivative data treatment.
31 . The method of any of the preceding claims, where the semi- derivative data treatment transforms at least a portion of a voltam metric current region to a peak.
32. The method of any of the preceding claims, where the determining comprises inputting at least one steady-state current value into a compensation equation.
33. The method of any of the preceding claims, where the determining the concentration of the analyte in the sample provides
53 α concentration value closer to that obtained from a reference instrument than if coulometry were substituted for the acyclic scan.
34. A 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.
35. The device of any of the preceding claims, where the analyte is glucose.
36. The device of any of the preceding claims, where the first reagent layer is on at least the working and counter electrodes.
37. The device of any of the preceding claims, comprising a second reagent layer on at least the counter electrode, the second reagent layer comprising at least one species of a redox pair.
38. The device of any of the preceding claims, where the electrical circuitry comprises means for applying an acyclic scan to the sensor strip, where the senor strip contains the sample.
39. The device of any of the preceding claims, 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.
40. The device of any of the preceding claims, 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.
41 . The device of any of the preceding claims, 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 20O mV.
42. A method of determining the concentration of an analyte in a sample, comprising: applying a voltammetric forward linear scan to the sample; measuring the resulting currents; applying a data treatment to the measured currents; and determining the concentration of the analyte in the sample.
43. The method of any of the preceding claims, where the analyte is glucose.
44. The method of any of the preceding claims, where the sample is whole blood.
55
45. The method of any of the preceding claims, further comprising applying a voltammetric reverse linear scan to the sample at a reversing point of the forward linear scan.
46. The method of any of the preceding claims, where the voltammetric forward and reverse linear scans form a cyclic scan.
47. The method of any of the preceding claims, where the forward scan comprises changing the voltage of the scan at a rate of at least 1 76 mV/second.
48. The method of any of the preceding claims, where the forward scan comprises changing the voltage of the scan at a rate of at least 500 mV/second.
49. The method of any of the preceding claims, where the forward scan comprises a scan range from 400 to 1000 mV.
50. The method of any of the preceding claims, where the reverse scan comprises at least 25 mV of steady-state region.
51 . The method of any of the preceding claims, where the steady-state region of the scan comprises a change in electrochemical current with respect to voltage of at most ±10 %.
52. The method of any of the preceding claims, where the reversing point is selected to provide from 25 to 400 mV of steady- state region.
53. The method of any of the preceding claims, where the forward scan comprises at least one voltage providing at least a 100:1 concentration ratio between two species of a redox pair.
56
54. The method of any of the preceding claims, where the forward scan comprises at least one potential at a working electrode of at least 180 mV.
55. The method of any of the preceding claims, where the data treatment is selected from the group consisting of semi-integral, derivative, semi-derivative, and combinations thereof.
56. The method of any of the preceding claims, where the data treatment comprises a semi-integral data treatment.
57. The method of any of the preceding claims, where the data treatment comprises semi-integrating the currents from the forward linear scan and determining a steady-state semi-integral current.
58. The method of any of the preceding claims, where the semi- integral data treatment lacks a time-dependence factor.
59. The method of any of the preceding claims, where the data treatment comprises a semi-derivative data treatment.
60. The method of any of the preceding claims, where the semi- derivative data treatment transforms at least a portion of a voltammetric current region into a peak.
61 . The method of any of the preceding claims, where the determining comprises hematocrit compensation.
62. The method of any of the preceding claims, where the compensation comprises determining a ratio of a peak current value to a steady-state current value.
57
63. The method of any of the preceding claims, where the determining comprises inputting at least one steady-state current value into a compensation equation.
64. The method of any of the preceding claims, where the determining the concentration of the analyte in the sample provides a concentration value closer to that obtained from a reference instrument than if coulometry were substituted for the voltammetric forward linear scan.
65. 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.
66. The device of any of the preceding claims, where the analyte is glucose.
67. The device of any of the preceding claims, where the voltammetric scanning comprises a linear scan.
58
68. The device of any of the preceding claims, where the voltammetric scanning comprises a cyclic scan.
69. The device of any of the preceding claims, where the first reagent layer is on at least the working and counter electrodes.
70. The device of any of the preceding claims, 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.
71 . The device of any of the preceding claims, where the electrical circuitry comprises means for applying a voltammetric scan to the sensor strip, where the senor strip contains the sample.
72. The device of any of the preceding claims, where the means for applying a voltammetric scan to the sensor strip comprises a means for applying a linear scan to the sensor strip.
73. The device of any of the preceding claims, where the means for applying a voltammetric scan to the sensor strip comprises a means for applying a cyclic scan to the sensor strip.
74. A handheld measuring device, for determining the concentration of an analyte in a sample, where the device is adapted to receive a sensor strip and the device comprises: contacts; at least one display; and electronic circuitry establishing electrical communication between the contacts and the display, comprising:
59 an electric charger and a processor in electrical communication, the processor in electrical communication with a computer readable storage medium comprising computer readable software code, which when executed by the processor, causes the processor to implement a data treatment selected from the group consisting of semi-integral, derivative, semi-derivative, and combinations thereof.
75. The device of any of the preceding claims, where the analyte is glucose.
76. The device of any of the preceding claims, where the data treatment comprises a semi-integral data treatment.
77. The device of any of the preceding claims, where the data treatment comprises a derivative data treatment.
78. The device of any of the preceding claims, where the data treatment comprises a semi-derivative data treatment.
79. The device of any of the preceding claims, where the computer readable storage medium further comprises computer readable software code, which when executed by the processor, causes the electric charger to apply a voltammetric scan through the contacts.
80. The device of any of the preceding claims, where the computer readable software code, which when executed by the processor, causes the electronic circuitry to implement the method of any of the proceeding claims.
60
81 . The device of any of the preceding claims, where the computer readable software code, which when executed by the processor, causes the electronic circuitry to implement the method of any of the proceeding claims.
82. A handheld measuring device, for determining the concentration of an analyte in a sample, where the device is adapted to receive a sensor strip and the device comprises: contacts; at least one display; and electronic circuitry establishing electrical communication between the contacts and the display, comprising: an electric charger and a processor in electrical communication, the processor in electrical communication with a computer readable storage medium comprising computer readable software code, which when executed by the processor, causes the electric charger to apply a voltammetric scan through the contacts.
83. The device of any of the preceding claims, where the voltammetric scan comprises an acyclic scan.
84. The device of any of the preceding claims, where the voltammetric scan comprises a linear scan.
85. The device of any of the preceding claims, where the voltammetric scan comprises a cyclic scan.
86. The device of any of the preceding claims, where the computer readable software code, which when executed by the
61 processor, causes the electronic circuitry to implement the method of any of the proceeding claims.
87. The device of any of the preceding claims, where the computer readable software code, which when executed by the processor, causes the electronic circuitry to implement the method of any of the proceeding claims.
62
PCT/US2005/017009 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes WO2005114164A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
BRPI0511098-0A BRPI0511098A (en) 2005-05-16 2005-05-16 voltammetric systems for assaying biological analytes
CN200580022790.2A CN1981192B (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
KR1020147002795A KR101427559B1 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
CA2566492A CA2566492C (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
AU2005246314A AU2005246314B2 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
MXPA06013232A MXPA06013232A (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes.
KR1020127020371A KR101440704B1 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
KR1020067026353A KR101328856B1 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
EP05749689A EP1751533A2 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
JP2007513447A JP4773428B2 (en) 2004-05-14 2005-05-16 Voltammetric system for analyzing biological analytes
US11/596,309 US8287717B2 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
NO20065711A NO20065711L (en) 2004-05-14 2006-12-12 Voltametric systems for assay of biological analytes
AU2009202915A AU2009202915B2 (en) 2004-05-14 2009-07-20 Voltammetric systems for assaying biological analytes
US13/611,557 US8871079B2 (en) 2004-05-14 2012-09-12 Voltammetric systems for assaying biological analytes
US14/495,556 US9784706B2 (en) 2004-05-14 2014-09-24 Voltammetric systems for assaying biological analytes
US15/696,402 US10416110B2 (en) 2004-05-14 2017-09-06 Voltammetric systems for assaying biological analytes
US16/529,539 US20190353609A1 (en) 2004-05-14 2019-08-01 Voltammetric systems for assaying biological analytes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US57138804P 2004-05-14 2004-05-14
US60/571,388 2004-05-14

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US11/596,309 A-371-Of-International US8287717B2 (en) 2004-05-14 2005-05-16 Voltammetric systems for assaying biological analytes
US13/611,557 Division US8871079B2 (en) 2004-05-14 2012-09-12 Voltammetric systems for assaying biological analytes

Publications (3)

Publication Number Publication Date
WO2005114164A2 WO2005114164A2 (en) 2005-12-01
WO2005114164A3 WO2005114164A3 (en) 2006-01-26
WO2005114164B1 true WO2005114164B1 (en) 2006-03-23

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Country Status (16)

Country Link
US (5) US8287717B2 (en)
EP (1) EP1751533A2 (en)
JP (4) JP4773428B2 (en)
KR (3) KR101328856B1 (en)
CN (2) CN1981192B (en)
AU (2) AU2005246314B2 (en)
CA (1) CA2566492C (en)
CR (1) CR8763A (en)
HK (1) HK1199498A1 (en)
MA (1) MA28581B1 (en)
MX (1) MXPA06013232A (en)
NO (1) NO20065711L (en)
RU (1) RU2386960C2 (en)
TW (1) TW200606427A (en)
WO (1) WO2005114164A2 (en)
ZA (1) ZA200610116B (en)

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