Measuring device and methods for use therewith

• US 8,591,815 B2
• Filed: 05/16/2011
• Issued: 11/26/2013
• Est. Priority Date: 05/30/2004
• 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: Harding, Ian, Iyengar, Sridhar G., Wei, Baoguo, Forest, Martin, Diamond, Steven
• Primary Examiner(s): Hyun, Paul
• Application Number:
  US13/108,621
• Publication Number:
  US 20110267028A1
• Time in Patent Office: 925 Days
• Field of Search: 422/82.01, 422/82.02, 422/68.1, 204/403.01, 324/76.11
• US Class Current: 422/68.1
• CPC Class Codes: G01N 27/28 Electrolytic cell components
• 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 27/403 Cells and electrode assemblies
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q

Abstract

The ability to switch at will between amperometric measurements and potentiometric measurements provides great flexibility in performing analysis of unknowns. Apparatus and methods can provide such switching to collect data from an electrochemical cell. The cell may contain a reagent disposed to measure glucose in human blood.

Claims

1. A method for use of a test equipment apparatus having an electrochemical cell disposed to receive a fluid sample, said electrochemical cell comprising first and second electrodes and a reagent reactive with an analyte in the fluid sample to yield a electrical signal in response to an applied current or potential, wherein the magnitude of the electrical signal is dependent on the presence of analyte, the apparatus further comprising electronic circuitry, the method comprising the steps of:

under automatic control of the electronic circuitry, applying current or potential to the electrochemical cell for a period of time sufficient generate a chemical potential between the first and second electrodes;

measuring the electrical signal;

thereafter, under automatic control of the electronic circuitry, ceasing the application of the current or potential to the cell;

thereafter, under automatic control of the electronic circuitry, measuring a decay in the chemical potential at the cell; and

evaluating the measured electrical signal and the measured decay of chemical potential to evaluate a measure of the analyte in the fluid sample.

2. The method of claim 1, wherein the fluid sample is blood.

3. The method of claim 2, wherein a potential difference is applied, and the electrical signal is a measured current.

4. The method of claim 3 wherein the electrochemical cell comprises a reagent reactive with glucose, and the measure of analyte in the blood is a concentration of glucose in the fluid sample.

5. The method of claim 4 wherein the step of measuring decay of chemical potential at the cell comprises measuring a potential between the first and second electrodes.

6. The method of claim 3 wherein the step of measuring decay of chemical potential at the cell comprises measuring a potential between the first and second electrodes.

7. The method of claim 2 wherein the step of measuring decay of chemical potential at the cell comprises measuring a potential between the first and second electrodes.

8. The method of claim 1, wherein the bodily fluid is urine.

9. The method of claim 8, wherein a potential difference is applied, and the electrical signal is a measured current.

10. The method of claim 1, wherein a potential difference is applied, and the electrical signal is a measured current.

11. The method of claim 10 wherein the step of measuring decay of chemical potential at the cell comprises measuring a potential between the first and second electrodes.

12. A test equipment comprising:

an electrochemical cell comprising at least first and second electrodes and a reagent reactive with a constituent of a fluid sample;

a source of potential or current external to the electrochemical cell and connected to the electrochemical cell for application of potential or current to the first and second electrodes;

measurement circuitry external to the electrochemical cell for measuring an electrical signal generated in the electrochemical cell in response to application of potential or current;

electronic control means;

the electronic control means coupled with the source of potential or current to controllably apply the source of potential or current to the electrochemical cell;

and potentiometric circuitry for measuring a decay in a chemical potential between the first and second electrodes in the absence of an applied potential or current;

wherein the electronic control means is coupled with the source of potential or current to automatically cease application of potential or current to the electrochemical cell after an electrical signal has been measured, and then cause the potentiometric circuitry to measure the decay in chemical potential.

13. The test equipment of claim 12, further comprising a processor for evaluating a measured electrical signal and a measured decay of chemical potential to produce a measure of the constituent of the fluid sample.

14. The test equipment of claim 12 further comprising a housing, wherein the electrochemical test cell is part of a test strip, wherein the electrochemical test cell is external to the housing and wherein the test strip is electrically connected to a connector at the housing, the housing containing the source of potential or current, the measuring circuitry, the potentiometric circuitry, and the electronic control means.

15. The test equipment of claim 14 wherein the first electrode comprises a working electrode, and the second electrode comprises a reference or counter electrode.

16. The test equipment of claim 15, wherein the housing is sized to provide a hand-held test equipment.

17. The test equipment of claim 14, wherein the housing is sized to provide a hand-held test equipment.

18. The test equipment of claim 14, further comprising a processor for evaluating a measured electrical signal and a measured decay of chemical potential to produce a measure of the constituent of the fluid sample.

19. The test equipment of claim 12, wherein the source of potential or current external to the electrochemical cell is a source of current.

20. The test equipment of claim 19, further comprising a housing, wherein the electrochemical test cell is part of a test strip, wherein the electrochemical test cell is external to the housing and wherein the test strip is electrically connected to a connector at the housing, the housing containing the source of potential or current, the measuring circuitry, the potentiometric circuitry, and the electronic control means.

21. The test equipment of claim 20, wherein the first electrode comprises a working electrode, and the second electrode comprises a reference or counter electrode.

22. The test equipment of claim 21, wherein the housing is sized to provide a hand-held test equipment.

23. The test equipment of claim 20, wherein the housing is sized to provide a hand-held test equipment.

24. The test equipment of claim 23, further comprising a processor for evaluating a measured electrical signal and a measured decay of chemical potential to produce a measure of the constituent of the fluid sample.

25. A test equipment according to claim 12, wherein the electronic control means comprises a plurality of switches each switchable between first and second positions and an amplifier having an inverting input and a non-inverting input,

wherein when said plurality of switches is in the first position the amplifier measures current through the second electrode, thereby measuring current through the electrochemical cell, and wherein when the switches are in the second position the amplifier permits measurement of a voltage between the first and second electrodes.

26. The test equipment of claim 25, wherein the plurality of switches comprises first, second and third switches, the first switch connecting the second electrode and the inverting input of the amplifier, the second switch connecting the second electrode and the non-inverting input of the amplifier, and the third switch connecting the non-inverting input of the amplifier and a reference voltage, wherein the first position is defined by the first and third switches being closed and the second switch being open, and the second position is defined by the first and third switches being open and the second switch being closed.