System and method for detecting used and dried sensors

• US 9,164,056 B2
• Filed: 08/31/2012
• Issued: 10/20/2015
• Est. Priority Date: 07/27/2012
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Harrison, Bern
• Primary Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/600,441
• Publication Number:
  US 20140027308A1
• Time in Patent Office: 1,145 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/04 by investigating resistance
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

Systems and methods for detecting dried test strips are provided, where a dried test strip may be one that has been re-inoculated with a biological sample after having already been previously inoculated with another sample at an earlier time (e.g., hours or days before). In various aspects, a biosensor such as an amperometric glucose biosensor (“meter”) may apply one or more input electrical signals to an inoculated test strip having at least a pair of electrodes in contact with the biological sample. The meter may measure output current value(s) resulting in response to the input electrical signals applied to the test strip. The meter may determine whether the test strip is a dried test strip by comparing a ratio of the measured output current value(s) with a boundary ratio value.

Claims

1. A method for detecting reuse of a test strip in a biosensor, the method comprising:

inoculating a test strip with a liquid, the test strip having a dry reagent and a plurality of electrodes including a bare electrode which is not in contact with the dry reagent in an unused condition of the test strip, the inoculating step being performed so that the liquid contacts the dry reagent, the bare electrode and one or more other electrodes;

while the electrodes are in contact with the liquid, applying an electrical potential between the bare electrode and one or more of the other electrodes;

measuring a current flow between the bare electrode and one or more of the other electrodes responsive to application of the potential; and

determining, based on one or more parameters of the measured current flow, whether the test strip is one that has been previously wetted and dried before the inoculating step.

2. The method of claim 1, wherein the measuring step includes the step of measuring a first current value at a first time during the potential applying step and measuring a second current value at a second, later time during the potential applying step.

3. The method of claim 2, wherein the determining step includes:

calculating a ratio between the second current value and the first current value; and

comparing the ratio between the second current value and the first current value with a boundary ratio value.

4. The method of claim 3, further comprising:

selecting the boundary ratio value based at least in part on a current value measured during the potential-applying step.

5. The method of claim 4, wherein the selecting step is performed based at least in part on one of the first and second current values.

6. The method of claim 3, wherein the ratio is the ratio of the second current value divided by the first current value, and the determining step includes determining that the test strip is one that had been previously wetted and dried when the ratio is less than or equal to the boundary ratio value.

7. The method of claim 1, wherein:

the one or more other electrodes on the strip include a working electrode a counter electrode.

8. The method of claim 7, further comprising:

applying at least one input electrical signal between the working electrode and the counter electrode;

measuring at least one output signal resulting in response from application of the at least one input electrical signal; and

,

determining a concentration of an analyte in the sample based at least in part on the at least one output signal.

9. The method of claim 8, further comprising

correcting the determined concentration of the analyte in the sample based at least in part on at least one parameter of the measured current flow.

10. The method of claim 9, wherein the liquid is blood and the correcting step includes correcting the determined concentration for an effect related to hematocrit.

11. The method of claim 10, wherein the input electrical signal is a potential and the output electrical signal is a current flowing between the working and counter electrodes.

12. The method of claim 11, wherein the analyte is glucose and the dry reagent includes an enzyme reactive with glucose and a mediator.

13. The method of claim 1, further comprising:

comparing a current value measured during the potential-applying step with a threshold current value; and

,

based on the comparison, determining whether the test strip is one that has been previously wetted with blood and dried before the inoculating step.

14. The method of claim 1, wherein the bare electrode extends across a flow channel of the test strip at a location proximal to a working electrode and a counter electrode, and outside a region occupied by the dry reagent.

15. A biosensor comprising:

a processor;

a memory storing one or more executable instructions, the instructions, when executed by the processor, configuring the processor to;

apply an electrical potential between a bare electrode and one or more other electrodes of a test strip while the electrodes of the test strip are in contact with a liquid, the test strip having a dry reagent, wherein the bare electrode is not in contact with the reagent in an unused condition of the test strip;

measure a current flow between the bare electrode and one or more of the other electrodes responsive to application of the potential; and

determine, based on one or more parameters of the measured current flow, whether the test strip is one that has been previously wetted and dried before inoculation of the test strip with the liquid.

16. The biosensor of claim 15, wherein the processor is configured to:

measure a first current value at a first time during the potential applying step;

measure a second current value at a second, later time during the potential applying step;

calculate a ratio between the second current value and the first current value; and

compare the ratio between the second current value and the first current value with a boundary ratio value.

17. The biosensor of claim 15, wherein the bare electrode extends across a flow channel of the test strip at a location proximal to a working electrode and a counter electrode, and outside a region occupied by the dry reagent.

18. A non-transitory computer-readable storage unit on which computer readable instructions of a program are stored, the instructions, when executed by a processor, causing the processor to:

apply an electrical potential between a bare electrode and one or more other electrodes of a test strip while the electrodes of the test strip are in contact with a liquid, the test strip having a dry reagent, wherein the bare electrode is not in contact with the reagent in an unused condition of the test strip;

measure a current flow between the bare electrode and one or more of the other electrodes responsive to application of the potential; and

determine, based on one or more parameters of the measured current flow, whether the test strip is one that has been previously wetted and dried before inoculation of the test strip with the liquid.