Passive sample detection to initiate timing of an assay

• US 20030106809A1
• Filed: 12/10/2001
• Published: 06/12/2003
• Est. Priority Date: 12/10/2001
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Kermani, Mahyar Z., Teodorczyk, Maria, Ohara, Timothy
• Granted Patent: US 6,872,299 B2
• Time in Patent Office: Days
• US Class Current: 205/775
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

The present invention provides methods and systems for passively and automatically detecting the presence of a sample (the “sample detection phase”) upon application of the sample to a biosensor, identifying the sample detection time and then initiating the measurement of a targeted characteristic, e.g., the concentration of one or more analytes, of the sample (the “measurement phase”), immediately upon sample detection. The subject methods and systems do not employ or involve the application of an electrical signal from an external source to the electrochemical cell for purposes of performing the sample detection phase and are, thus, less complicated and involve fewer steps and components.

Claims

1. A method for determining the presence of a sample within an electrochemical cell, comprising the steps of:

applying said sample to said electrochemical cell in the absence of an external signal applied to said electrochemical cell;

producing a potential difference within said electrochemical cell without applying an external signal to the electrochemical cell; and

monitoring said potential difference.

2. The method of claim 1 wherein said electrochemical cell comprises two electrodes and said step of producing a potential difference comprises providing a signal producing system within said electrochemical cell wherein said signal producing system is deposited asymmetrically on said electrodes.

3. The method of claim 2 wherein the step of applying said sample to the said electrochemical cell comprises contacting said signal producing system with said sample wherein an electrochemical reaction is created within said electrochemical cell.

4. The method of claim 3 wherein said electrochemical cell comprises two electrodes and said signal producing system comprises an enzyme component and a mediator component, wherein said step of producing a potential difference comprises the steps of:

depositing said signal producing system asymmetrically on said electrodes;

dissolving said enzyme component and said mediator component within said sample wherein a substance is released from said signal producing system in concentration sufficient to generate a potential difference between electrodes without application of an external potential source.

5. The method of claim 4 wherein said mediator component is reducible/oxidizable in said sample and said substance is oxidized/reduced therefrom.

6. The method of claim 4 wherein said mediator component is ferricyanide and said substance is ferrocyanide.

7. The method of claim 4 wherein said enzyme component is selected to target glucose within said sample and comprises one of the group consisting of glucose oxidase and glucose dehydrogenases.

8. The method of claim 1 said step of monitoring is performed until said potential difference reaches a predetermined value.

9. A method for measuring the concentration of an analyte of a sample that is applied to an electrochemical cell, comprising the steps of:

applying said sample to said electrochemical cell in the absence of an external electrical signal applied to said electrochemical cell;

monitoring the potential difference across the electrochemical cell;

determining a sample detection time by noting when said potential difference increases above a predetermined threshold voltage;

applying a predetermined test voltage to said electrochemical cell;

measuring an electrical response to said applied predetermined test voltage at a predetermined time after applying said predetermined test voltage; and

calculating said analyte concentration using said measured electrical response.

10. The method of claim 9 wherein said electrochemical cell comprises a chemical component for reacting with said sample and wherein said predetermined test voltage is determined based on said chemical component.

11. The method of claim 10 wherein said chemical component is ferricyanide.

12. The method of claim 11 wherein said predetermined test voltage is in the range from about 0 to 600 mV.

13. The method of claim 9 wherein said electrical response is the current through said electrochemical cell.

14. The method of claim 9 wherein said predetermined test time is in the range from about 3 to 40 seconds.

15. The method of claim 9 wherein said electrical cell comprises two spaced-apart electrodes and a reagent system within the area between said electrodes, and wherein said potential difference is produced by the reaction of said reagent system with said sample.

16. The method of claim 15 wherein said reagent system comprises an enzyme component and a mediator component, wherein said enzyme component is selected for reacting with said target analyte and wherein said mediator component determines said predetermined test voltage.

17. A method for measuring the concentration of an analyte of a sample, comprising the steps of:

providing an electrochemical cell comprising a signal producing systems comprising an enzyme component selected for reacting with said analyte and a reducible/oxidizable mediator component selected for reacting with said enzyme component;

monitoring the potential difference across the electrochemical cell;

applying said sample to said electrochemical cell wherein said analyte causes said enzyme component and said reducible/oxidizable mediator component to dissolve and thereby release a oxidized/reduced mediator component;

determining a sample detection time by noting when said potential difference falls below a predetermined threshold voltage;

applying a predetermined test voltage to said electrochemical cell;

measuring the current in response to said applied predetermined test voltage at a predetermined time after applying said predetermined test voltage; and

calculating said analyte concentration using said measured current.

18. The method of claim 17 wherein said analyte is glucose, said mediator component is ferricyanide and said substance is ferrocyanide.

19. The method of claim 17 wherein said potential difference is proportional to the concentration of said mediator component to said substance.

20. A system for measuring analyte concentration in a sample that has been applied between a working and reference/counter electrode of an electrochemical cell, comprising, in electrical communication:

means for isolating said electrodes from application of an electrical signal from a source external to said electrochemical cell;

means for monitoring a potential difference across the electrodes;

means for determining when said potential difference falls below a predetermined threshold voltage to indicate sample detection;

means responsive to sample detection for applying a predetermined test voltage to said sample;

means for measuring a resulting electrical response to said applied predetermined test voltage; and

means for calculating said analyte concentration by using said measured electrical response.

21. The system of claim 20 wherein said system is a meter configured for operatively receiving said electrochemical cell.

22. The system of claim 20 wherein said electrochemical cell is configured within a test strip.

23. The system of claim 20 wherein said electrochemical cell is configured within a microneedle.

24. A kit for measuring analyte concentration in a biological sample to be applied to an electrochemical test strip, comprising:

a system according to claim 20 configured to received said test strip and to measure said analyte concentration; and

instructions for using said system to measure analyte concentration in said biological sample.

25. The kit of claim 24 further comprising at least one electrochemical test strip comprising an electrochemical cell comprising a signal producing system comprising an enzyme component selected for reacting with said analyte and a mediator component selected for oxidizing said enzyme component to an active form, where said mediator component contains a substance which upon dissolution of reagent within said cell causes a potential difference to be generated across the electrochemical cell.