Analyte test instrument having improved versatility

• US 9,234,865 B2
• Filed: 12/18/2014
• Issued: 01/12/2016
• 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, ALEXANDER STEPHAN
• Application Number:
  US14/575,753
• Publication Number:
  US 20150168338A1
• Time in Patent Office: 390 Days
• US Class Current: 1/1
• 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. A method for performing an assay using an analyte test instrument, the analyte test instrument comprising:

a test port for receiving a test strip;

a microprocessor for executing instructions downloaded to 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,

wherein the method comprises;

inserting a test strip into the test port of the analyte test instrument, wherein the test strip circuit of the analyte test instrument is in a two electrode configuration;

after inserting the test strip, applying a sample to the test strip;

running a first portion of an assay on the sample applied to the test strip;

switching the test strip circuit of the analyte test instrument from the two electrode configuration to a three electrode configuration;

running a second portion of the assay on the sample applied to the test strip; and

after running the second portion of the assay, removing the test strip from the test port.

2. The method according to 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, and wherein the method comprises calibrating the analyte test instrument using a calibration strip prior to inserting the test strip into the test port.

3. The method according to claim 1, wherein the analyte test instrument is configured to determine the concentration of an analyte in the sample, and wherein the assay is an analyte concentration determining assay.

4. The method according to claim 3, wherein the analyte is selected from the group consisting of:

glucose, a ketone body, and lactate.

5. The method according to claim 4, wherein the analyte is glucose.

6. The method according to claim 3, wherein the analyte test instrument comprises a display, and wherein the method comprises displaying a determined analyte concentration on the display.

7. The method according to claim 6, wherein the method comprises displaying one or more messages to a user of the analyte test instrument.

8. The method according to claim 7, wherein the displaying comprises displaying a warning message to a user of the analyte test instrument.

9. The method according to claim 1, wherein the analyte test instrument comprises a memory for storing instructions and information.

10. The method according to claim 9, wherein the memory is configured to store results of one or more assays performed using the analyte test instrument.

11. The method according to claim 10, comprising enabling a user of the analyte test instrument to recall and display the results of the one or more assays.

12. The method according to claim 1, wherein the analyte test instrument comprises software configured to generate menus accessible by a user of the analyte test instrument, and wherein the method comprises providing the user access to the menus.

13. The method according to claim 1, wherein the analyte test instrument is configured to transmit data to one or more external devices, and wherein the method comprises transmitting data to one or more external devices.

14. A method of performing a glucose concentration determining assay using a glucose test instrument, the glucose test instrument comprising:

a test port for receiving a glucose test strip;

a microprocessor for executing instructions downloaded to the glucose 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,

wherein the method comprises;

inserting a glucose test strip into the test port of the glucose test instrument, wherein the test strip circuit of the glucose test instrument is in a two electrode configuration;

after inserting the glucose test strip, applying a sample to the test strip;

running a first portion of a glucose concentration determining assay on the sample applied to the test strip;

switching the test strip circuit of the glucose test instrument from the two electrode configuration to a three electrode configuration;

running a second portion of the glucose concentration determining assay on the sample applied to the test strip; and

after running the second portion of the glucose concentration determining assay, removing the test strip from the test port.

15. The method according to claim 14, 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, and wherein the method comprises calibrating the glucose test instrument using a calibration strip prior to inserting the glucose test strip into the test port.

16. The method according to claim 14, wherein the glucose test instrument comprises a display, and wherein the method comprises displaying a determined glucose concentration on the display.

17. The method according to claim 16, wherein the method comprises displaying one or more messages to a user of the glucose test instrument.

18. The method according to claim 17, wherein the displaying comprises displaying a warning message to a user of the glucose test instrument.

19. The method according to claim 14, wherein the analyte test instrument comprises a memory configured to store results of one or more glucose concentration determining assays performed using the glucose test instrument, and wherein the method comprises enabling a user of the glucose test instrument to recall and display the results of the one or more glucose concentration determining assays.

20. The method according to claim 14, wherein the glucose test instrument is configured to transmit data to one or more external devices, wherein the method comprises transmitting data to one or more external devices.