Method and apparatus for assay of electrochemical properties

• US 8,123,920 B2
• Filed: 03/05/2009
• Issued: 02/28/2012
• Est. Priority Date: 08/21/2003
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Iyengar, Sridhar G., Harding, Ian
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/398,321
• Publication Number:
  US 20090166225A1
• Time in Patent Office: 1,090 Days
• Field of Search: 204/401, 20440301-40315, 204/406, 205/777.5, 205/778, 205/792, 324/114, 324/115
• US Class Current: 204/403.14
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4168 Oxidation-reduction potential, e.g. for chlorination of water water analysis G01N33/18

Abstract

The presence of a select analyte in the sample is evaluated in an electrochemical system using a conduction cell-type apparatus. A potential or current is generated between the two electrodes of the cell sufficient to bring about oxidation or reduction of the analyte or of a mediator in an analyte-detection redox system, thereby forming a chemical potential gradient of the analyte or mediator between the two electrodes After the gradient is established, the applied potential or current is discontinued and an analyte-independent signal is obtained from the relaxation of the chemical potential gradient. The analyte-independent signal is used to correct the analyte-dependent signal obtained during application of the potential or current. This correction allows an improved measurement of analyte concentration because it corrects for device-specific and test specific factors such as transport (mobility) of analyte and/or mediator, effective electrode area, and electrode spacing (and as a result, sample volume), without need for separate calibration values. The analysis can be performed using disposable test strips in a hand held meter, for example for glucose testing.

Claims

1. An apparatus comprising:

(a) a housing having a space for receiving an electrochemical cell comprising two electrodes;

(b) means for applying a potential or a current between the two electrodes of the electrochemical cell when it is received within the housing;

(c) means for measuring oxidation or reduction of an analyte or a mediator in an analyte-detection system occurring within the electrochemical cell when the potential or current is being applied;

(d) means for switching the potential or current off after a period of time during which a chemical potential gradient is established between the two electrodes;

(e) means for monitoring the decay of the chemical potential gradient after the potential or current is switched off;

(f) programmed data processing means for combining the measured oxidation or reduction with the monitored decay to produce an indication of the presence of the analyte in the sample; and

(g) output means for conveying the indication of the presence of the analyte in the sample to a user.

2. The apparatus of claim 1, wherein the apparatus comprises a potentiostat as the means for applying a potential.

3. The apparatus of claim 2, wherein the apparatus comprises a switch for open-circuiting the electrochemical cell as the means for switching off the potential.

4. The apparatus of claim 1, wherein the apparatus is hand-held.

5. A combination of an electrochemical test cell comprising two electrodes and an apparatus comprising:

(a) a housing having a space for receiving the electrochemical cell electrodes;

(b) means for applying a potential or a current between the two electrodes of the electrochemical cell when it is received within the housing;

(c) means for measuring oxidation or reduction of an analyte or a mediator in an analyte-detection system occurring within the electrochemical cell when the potential or current is being applied;

(d) means for switching the potential or current off after a period of time during which a chemical potential gradient is established between the two electrodes;

(e) means for monitoring the decay of the chemical potential gradient after the potential or current is switched off;

(f) programmed data processing means for combining the measured oxidation or reduction with the monitored decay to produce an indication of the presence of the analyte in the sample; and

(g) output means for conveying the indication of the presence of the analyte in the sample to a user.

6. The combination of claim 5, wherein the electrochemical test cell is a single-use glucose sensor.

7. The combination of claim 5, wherein the electrochemical test cell is a single-use glucose enzyme bio-sensor.

8. An apparatus for detecting an analyte in a sample comprising

(a) a conductance-cell electrochemical sensor for the analyte,

(b) a transducer control apparatus connected to the sensor for applying a stimulus waveform to the electrochemical sensor, wherein the transducer control apparatus is switchable between a first state in which a potential stimulus waveform is applied and a second state in which a current stimulus waveform is applied, and wherein application of the stimulus waveform generates a response signal from the electrochemical sensor, and

(c) a computing apparatus connected to receive the response signal and generate therefrom an indication of analyte in the sample,

wherein the transducer control apparatus comprises:

a stimulus application unit for applying a stimulus waveform,

a first conductive lead connecting the stimulus application unit to a first electrode of the electrochemical sensor;

a second conductive lead connecting the stimulus application unit and a second electrode of the electrochemical sensor;

a current quantification unit disposed to measure current in the first conductive lead,

a potential quantification unit connected to the first conductive lead and the second conductive lead to measure a potential difference therebetween, and

a switch disposed in the second conductive lead, between the stimulus application unit and the connection point of the potential quantification unit.

9. Handheld test apparatus comprising:

an electrochemical cell comprising a reagent reactive with an analyte and at least two electrodes;

means for applying a potential between the electrodes,

amperometric means external to the electrochemical cell for measuring current passed through the electrochemical cell;

means to cease application of the potential between the electrodes of the electrochemical cell, and

potentiometric means for measurement of a potential at the electrochemical cell in the absence of the applied potential,

wherein the means for ceasing application of the potential and permitting measurement of the potential at the electrochemical cell comprises a switch disposed between a first electrode of the at least two electrodes and the means for applying potential to disconnect the first electrode from the means for applying a potential.

10. The test equipment of claim 9, wherein the electrochemical cell is a disposable test strip.

11. The test equipment of claim 10, wherein the constituent of human bodily fluid reactive with the reagent is glucose.