Analyte test instrument having improved versatility

• US 8,916,036 B2
• Filed: 11/23/2009
• Issued: 12/23/2014
• Est. Priority Date: 12/19/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Karinka, Shridhara Alva, Sanghera, Gurdial
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/623,894
• Publication Number:
  US 20100126856A1
• Time in Patent Office: 1,856 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 204/403.02
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• 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

Abstract

An analyte test instrument that has a test strip circuitry that can be configured using information provided by a calibration strip to perform assays with test strips having two electrodes and test strips having three electrodes. The analyte test instrument of this invention comprises:

• • (a) a test port for receiving a test strip;
  • (b) a microprocessor for executing instructions downloaded into the analyte test instrument;
  • (c) a test strip circuit capable of having a plurality of configurations, the configurations being set by the microprocessor, whereby an assay can be performed using the test strip.

Claims

1. An analyte test instrument suitable for performing an assay, said analyte test instrument comprising:

a test port for receiving a test strip;

a microprocessor for executing instructions downloaded to the analyte test instrument;

a display in communication with the microprocessor for displaying assay results to a user of the analyte test instrument; and

a test strip circuit that switches between a two electrode configuration and a three electrode configuration following sample application to the test strip and before removal of the test strip, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having two electrodes to an assay with a test strip having three electrodes or the microprocessor setting the switches of the test strip circuit from an assay with a test strip having three electrodes to an assay with a test strip having two electrodes, wherein the test strip circuit is in a two electrode configuration during a first portion of an assay and a three electrode configuration during a second portion of the assay.

2. The test instrument of claim 1, wherein the test port is configured to receive a calibration strip, which calibration strip is removable from the test port to allow a test strip to be inserted into the test port.

3. The analyte test instrument of claim 1, wherein the analyte test instrument is configured to determine concentration of an analyte in a sample.

4. The analyte test instrument of claim 3, wherein the analyte is glucose.

5. The analyte test instrument of claim 1, wherein the analyte test instrument is configured to determine analyte concentration in a sample and display the analyte concentration on the display.

6. The analyte test instrument of claim 1, wherein the display is configured to display one or more messages to a user of the analyte test instrument.

7. The analyte test instrument of claim 6, wherein the one or more messages comprises a warning message.

8. The analyte test instrument of claim 1, further comprising a memory for storing instructions and information.

9. The analyte test instrument of claim 8, wherein the memory is configured to store results of one or more assays performed using the analyte test instrument, and wherein the analyte test instrument comprises software which enables a user of the analyte test instrument to recall and display the results of the one or more assays.

10. The analyte test instrument of claim 8, wherein the instructions are selected from the group consisting of:

measurement delay time, sample incubation time, number of measurements to be taken during an assay, threshold against which voltage level can be compared, value of excitation voltage level applied to a test strip during an assay, analyte value conversion factors, failsafe assay threshold value, and configurations of the test strip circuit of the analyte test instrument.

11. The analyte test instrument of claim 1, wherein the analyte test instrument comprises software configured to generate menus accessible by a user of the analyte test instrument.

12. The analyte test instrument of claim 1, wherein the analyte test instrument comprises one or more replaceable batteries which provide power to the analyte test instrument.

13. The analyte test instrument of claim 1, wherein the analyte test instrument comprises software configured to control transmission of data to one or more external devices.

14. The analyte test instrument of claim 1, wherein the analyte test instrument is configured to allow a user of the analyte test instrument to set one or more configuration control parameters for the analyte test instrument.

15. The analyte test instrument of claim 1, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having two electrodes to an assay with a test strip having three electrodes.

16. The analyte test instrument of claim 1, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having three electrodes to an assay with a test strip having two electrodes.

17. The analyte test instrument of claim 1, wherein the test port comprises two sets of electrical contacts, whereby a first set of electrical contacts engages a first major surface of a test strip and a second set of electrical contacts engages a second major surface of said test strip.

18. A glucose test instrument suitable for performing an assay, said glucose test instrument comprising:

a test port for receiving a test strip,

a microprocessor for executing instructions downloaded to the glucose test instrument;

a display in communication with the microprocessor for displaying a determined glucose concentration to a user of the analyte test instrument; and

a test strip circuit that switches between a two electrode configuration and a three electrode configuration following sample application to the test strip and before removal of the test strip, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having two electrodes to an assay with a test strip having three electrodes or the microprocessor setting the switches of the test strip circuit from an assay with a test strip having three electrodes to an assay with a test strip having two electrodes, wherein the test strip circuit is in a two electrode configuration during a first portion of an assay and a three electrode configuration during a second portion of the assay.

19. The glucose test instrument of claim 18, wherein the test port is configured to receive a calibration strip, which calibration strip is removable from the test port to allow a test strip to be inserted into the test port.

20. The glucose test instrument of claim 18, wherein the glucose test instrument is configured to determine glucose concentration in a sample and display the glucose concentration on the display.

21. The glucose test instrument of claim 18, wherein the display is configured to display one or more messages to a user of the glucose test instrument.

22. The glucose test instrument of claim 21, wherein the one or more messages comprises a warning message.

23. The glucose test instrument of claim 18, further comprising memory for storing instructions and information.

24. The glucose test instrument of claim 23, wherein the memory is configured to store results of one or more assays performed using the glucose test instrument, and wherein the glucose test instrument comprises software which enables a user of the glucose test instrument to recall and display the results of the one or more assays.

25. The glucose test instrument of claim 18, wherein the glucose test instrument comprises software configured to generate menus accessible by a user of the analyte test instrument.

26. The glucose test instrument of claim 18, wherein the glucose test instrument comprises one or more replaceable batteries which provide power to the glucose test instrument.

27. The glucose test instrument of claim 18, wherein the glucose test instrument comprises software configured to control transmission of data to one or more external devices.

28. The glucose test instrument of claim 18, wherein the glucose test instrument is configured to allow a user of the glucose test instrument to set one or more configuration control parameters for the glucose test instrument.

29. The analyte test instrument of claim 18, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having two electrodes to an assay with a test strip having three electrodes.

30. The analyte test instrument of claim 18, wherein switching between the configurations comprises the microprocessor setting the switches of the test strip circuit from an assay with a test strip having three electrodes to an assay with a test strip having two electrodes.

31. The analyte test instrument of claim 18, wherein the test port comprises two sets of electrical contacts, whereby a first set of electrical contacts engages a first major surface of a test strip and a second set of electrical contacts engages a second major surface of said test strip.

32. The analyte test instrument of claim 23, wherein the instructions are selected from the group consisting of:

measurement delay time, sample incubation time, number of measurements to be taken during an assay, threshold against which voltage level can be compared, value of excitation voltage level applied to a test strip during an assay, analyte value conversion factors, failsafe assay threshold value, and configurations of the test strip circuit of the analyte test instrument.