Method for estimating distribution of sample

• US 10,197,523 B2
• Filed: 10/21/2016
• Issued: 02/05/2019
• Est. Priority Date: 04/09/2009
• Status: Active Grant

• Current Assignee: Bionime Corporation
• Original Assignee: Bionime Corporation
• Inventors: Huang, Chun-Mu, Hsu, Cheng-Teng
• Primary Examiner(s): Kessel, Maris R
• Application Number:
  US15/299,605
• Publication Number:
  US 20170038330A1
• Time in Patent Office: 837 Days
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• 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 27/404 Cells with anode, cathode and cell electrolyte on the same side of a permeable membrane which separates them from the sample fluid , e.g. Clark-type oxygen sensors

Abstract

The present invention relates to a method for estimating a distribution of a sample flowed from a first electrode toward a second electrode of an electrochemical test strip. A working voltage is provided between the first electrode and the second electrode for obtaining a first and a second currents, where a ratio of the first current to the second current is applied to estimate the distribution of the sample on the first and the second electrodes and an effectiveness of a measurement of a target analyte of the sample.

Claims

1. A determining method for a distribution of a target sample in a sensor consisting of a first electrode and a second electrode, each of which is coated with a reagent layer, and a concentration of an analyte in the target sample, comprising the steps of:

(a) providing the target sample flowing from the first electrode to the second electrode;

(b) immediately providing a switching circuit having one of a first configuration with a first switch set and a second switch set, and a second configuration with the first switch set and the second switch set;

(c) providing a digital signal to a control contact in the switching circuit to allow the switching circuit having the first configuration, such that the first switch set turns on when the second switch set turns off, for applying a first DC voltage with a voltage value across the first electrode and the second electrode for a first duration to make a potential of the first electrode higher than a potential of the second electrode, wherein the first electrode functions as a working electrode to generate a first Cottrell current, the second electrode functions as a counter electrode, and the target sample flows from the working electrode to the counter electrode;

(d) removing the first DC voltage for a first removing duration;

(e) reversing the digital signal to allow the switching circuit having the second configuration, such that the second switch sets turns on when the first switch set turns off, for applying a second DC voltage with a voltage value across the first electrode and the second electrode for a second duration to make the potential of the second electrode higher than the potential of the first electrode, wherein the second electrode functions as the working electrode to generate a second Cottrell current, the first electrode functions as the counter electrode, and the respective voltage values of the first and the second DC voltages are equal;

(f) removing the second DC voltage for a second removing duration;

(g) sequentially repeating steps (b) to (e) at least twice;

(h) adding up respective values of the first Cottrell currents and respective values of the second Cottrell currents respectively; and

(i) obtaining a ratio of a sum of the respective values of the first Cottrell currents over a sum of the respective values of the second Cottrell currents to determine a distribution of the target sample on the first and the second electrodes and the concentration of the analyte in the target sample, whereby the distribution of the target sample is determined as long as a sufficient volume of the target sample is within a range between 0.45 μ

L and 0.8 μ

L.

2. A method according to claim 1, wherein the first and the second DC voltages are determined via cyclic voltammograms, and S/N ratios of the first DC voltage and the second DC voltage are not smaller than 1.

3. A method according to claim 1, wherein the reagent layer has an enzyme and an electron transfer mediator, and the enzyme makes the target sample generate a reaction being one selected from a group consisting of an oxidation, a reduction and a redox.

4. A method according to claim 1, wherein the first and the second durations are between 3 ms to 20 ms.

5. A method according to claim 1, wherein the first and the second durations are equal.

6. A method according to claim 1, wherein the first removing and the second removing durations are between 0 ms to 20 ms.

7. A method according to claim 1, wherein the first removing and the second removing durations are equal.

8. A method according to claim 1, wherein the first electrode and the second electrode have respective electrochemical reaction areas being equal to each other.

9. A method according to claim 8, wherein both the first and the second electrodes are fully covered thereon by the target sample when the ratio is 1.

10. A method according to claim 1, wherein the first and the second electrodes have respective electrochemical reaction areas, and the electrochemical reaction area of the first electrode is not equal to that of the second electrode.

11. A method according to claim 1, wherein the sensor is an electrochemical sensor.

12. A method according to claim 1, wherein the first Cottrell current is proportional to a surface area of the first electrode covered by the target sample, and the second Cottrell current is proportional to the surface area of the second electrode covered by the target sample.

13. A method according to claim 1, wherein the detection is effective when the ratio is between 0.3 and 3.0.

14. A method according to claim 1, wherein the value of the first Cottrell current and the value of the second Cottrell current are recorded during the first and the second durations respectively.

15. A determining method for a distribution of a target sample, comprising the steps of:

(a) providing a first and a second electrodes;

(b) providing the target sample flowing from the first electrode to the second electrode;

(c) providing a switching circuit having one of a first configuration with a first switch set and a second switch set, and a second configuration with the first switch set and the second switch set;

(d) providing a digital signal to a control contact in the switching circuit to allow the switching circuit having the first configuration, such that the first switch set turns on when the second switch set turns off, for applying a first DC voltage with a voltage value across the first electrode and the second electrode to make a potential of the first electrode higher than a potential of the second electrode and to generate a first sensing current, wherein the first electrode functions as a working electrode, the second electrode functions as a counter electrode, and the target sample flows from the working electrode to the counter electrode;

(e) removing the first DC voltage;

(f) reversing the digital signal to allow the switching circuit having the second configuration, such that the second switch set turns on when the first switch set turns off, for applying a second DC voltage having the voltage value across the first electrode and the second electrode to make the potential of the second electrode higher than the potential of the first electrode and to generate a second sensing current, wherein the second electrode functions as the working electrode, and the first electrode functions as the counter electrode; and

(g) obtaining a ratio of a value of the first sensing current over a value of the second sensing current to determine the distribution of the target sample on the first and the second electrodes, whereby the distribution of the target sample is determined as long as a sufficient volume of the target sample is within a range between 0.45 μ

L, and 0.8 μ

L.

16. A method according to claim 15, wherein the first and the second electrodes are configured. on an electrochemical. strip.

17. A method according to claim 15, wherein the first and the second DC voltages are applied for a period for 3 ms to 20 ms.

18. A method according to claim 15, wherein the first and the second sensing currents are Cottrell currents.

19. A determining method, comprising the steps of:

(a) providing a first and a second electrodes;

(b) providing a target sample flowing from the first electrode to the second electrode;

(c) providing a switch circuit having one of a first configuration with a first switch set and a second switch set, and a second configuration with the first switch set and the second switch set;

(d) providing a digital signal to a control contact, in the switching circuit to allow the switching circuit having the first configuration, such that the first switch set turns on when the second switch set turns off, for applying a first DC voltage with a voltage value across the first electrode and the second electrode to make a potential of the first electrode higher than a potential of the second electrode, and to generate a first sensing current, wherein the first electrode functions as a working electrode, the second electrode functions as a counter electrode, and the target sample flows from the working electrode to the counter electrode;

(e) reversing the digital signal to allow the switching circuit having the second configuration, such that the second switch set turns on when the first switch set turns off, for applying a second DC voltage haying the voltage value across the first electrode and the second electrode to make the potential of the second electrode higher than the potential of the first electrode, and to generate a second sensing current, wherein the second electrode functions as the working electrode, and the first electrode functions as the counter electrode; and

(f) obtaining a ratio of a value of the first sensing current over a value of the second sensing current to determine the distribution of the target sample on the first and the second electrodes, whereby the distribution of the target sample is determined as long as a sufficient volume of the target sample is within a range between 0.45 μ

L and 0.8 μ

L.