Method and assembly for determining the temperature of a test sensor

• US 10,215,647 B2
• Filed: 12/14/2017
• Issued: 02/26/2019
• Est. Priority Date: 06/08/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Parasnis, Narasinha, Sun, Hoi-Cheong Steve, Wu, Mu
• Primary Examiner(s): Caputo, Lisa
• Assistant Examiner(s): Ahmed, Nasir U
• Application Number:
  US15/842,285
• Publication Number:
  US 20180106688A1
• Time in Patent Office: 439 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01K 15/005 Calibration
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 25/00 Investigating or analyzing materials by the use of thermal means G01N3/00 - G01N23/00 take precedence

Abstract

Methods and systems accurately determine an analyte concentration in a fluid sample. In an example embodiment, a receiving port receives a test sensor. The test sensor includes a fluid-receiving area for receiving a fluid sample. The fluid-receiving area contains a reagent that produces a measurable reaction with an analyte in the fluid sample. The test sensor has a test-sensor temperature and the reagent has a reagent temperature. A measurement system measures the reaction between the reagent and the analyte. A temperature-measuring system measures the test sensor temperature when the test sensor is received into the receiving port. A concentration of the analyte in the fluid sample is determined according to the measurement of the reaction and the measurement of the test sensor temperature. A diagnostic system determines an accuracy of the temperature-measuring system. The calculation of the analyte concentration may be adjusted according to the accuracy of temperature-measuring system.

Claims

1. A diagnostic system for determining accuracy of a temperature-measuring system of a device for determining analyte concentrations in fluid samples, the diagnostic system comprising:

a receiving port for receiving a test sensor, the test sensor including a fluid-receiving area containing a reagent that produces a measurable reaction with an analyte in a fluid sample;

a reference object at least partially located proximate the receiving port during temperature measurements, the reference object including at least one of a resistor or a light emitting diode (LED); and

a processing system configured to execute instructions embedded on a computer-readable medium, the instructions including the acts of;

applying a current to the reference object until the reference object achieves a reference temperature,

determining at least one test temperature for the reference object based on temperature measurements by the temperature-measuring system after the reference object achieves the reference temperature, and

determining the accuracy of the temperature-measuring system by comparing the at least one test temperature to the corresponding reference temperature.

2. The diagnostic system of claim 1, wherein the temperature-measuring system includes a plurality of temperature-measuring systems disposed at different locations within the device for determining analyte concentrations in fluid samples.

3. The diagnostic system of claim 1, wherein the determining the accuracy of the temperature-measuring system includes comparing the reference temperature to a plurality of test temperatures determined after the reference object achieves the reference temperature.

4. A diagnostic system for determining accuracy of a temperature-measuring system of a device for determining analyte concentrations in fluid samples, the device including a receiving port for test sensors and a measurement system for measuring reactions between a reagent and analyte, the diagnostic system comprising:

a reference object at least partially located proximate a receiving port during temperature measurements; and

a processing system configured to execute instructions embedded on a computer-readable medium, the instructions including the acts of;

applying a current to the reference object until the reference object achieves a reference temperature,

determining at least one test temperature for the reference object based on temperature measurements by the temperature-measuring system after the reference object achieves the reference temperature, and

determining the accuracy of the temperature-measuring system by comparing the at least one test temperature to the corresponding reference temperature.

5. The diagnostic system of claim 4, wherein the reference object includes at least one of a resistor or a light emitting diode (LED).

6. The diagnostic system of claim 4, wherein the reference object includes a resistor, the resistor being configured to receive the applied current to achieve the at least one reference temperature.

7. The diagnostic system of claim 4, wherein the reference object is removably insertable into the receiving port for the test sensors.

8. The diagnostic system of claim 4, further comprising a cooling element configured to cool the reference object to the reference temperature.

9. The diagnostic system of claim 4, wherein the temperature-measuring system includes a plurality of temperature-measuring systems disposed at different locations within a device for determining analyte concentrations in fluid samples.

10. The diagnostic system of claim 4, wherein the determining the accuracy of the temperature-measuring system includes comparing the reference temperature to a plurality of test temperatures determined after the reference object achieves the reference temperature.

11. The diagnostic system of claim 4, wherein the instructions further include the acts of calibrating the temperature-measuring system based on determined accuracy of the temperature-measuring system.

12. The diagnostic system of claim 11, wherein the calibrating occurs at a time after the manufacture and assembly of the device.

13. The diagnostic system of claim 11, wherein the determining the accuracy and the calibrating occur automatically on a periodic basis.

14. The diagnostic system of claim 11, wherein the calibrating includes correcting for one or more offset or gain errors associated with a signal generated by a temperature sensor of the temperature-measuring system.

15. A diagnostic system for determining accuracy of a temperature-measuring system of a device for determining analyte concentrations in fluid samples, the device including a receiving port for test sensors and a measurement system for measuring reactions between a reagent and analyte, the diagnostic system comprising:

a reference object at least partially located proximate the receiving port during temperature measurements; and

a processing system configured to execute instructions embedded on a computer-readable medium, the instructions including the steps of;

applying a current to the reference object until the reference object achieves a reference temperature,

determining a test rate of temperature change of the reference object based on at least one test temperature of the reference object determined via the temperature measuring system, and

determining the accuracy of the temperature-measuring system based on the at least one test temperature measurement of the reference object by comparing the test rate of temperature change to an expected rate of temperature change for the reference object.

16. The diagnostic system of claim 15, wherein the reference object includes at least one of a resistor or a light emitting diode (LED).

17. The diagnostic system of claim 15, further comprising a cooling element configured to cool the reference object to the reference temperature.

18. The diagnostic system of claim 15, wherein the temperature-measuring system includes a plurality of temperature-measuring systems disposed at different locations within a device for determining analyte concentrations in fluid samples.

19. The diagnostic system of claim 15, wherein the determining the accuracy of the temperature-measuring system includes comparing the reference temperature to a plurality of test temperatures determined after the reference object achieves the reference temperature.

20. The diagnostic system of claim 15, wherein the instructions further include the acts of calibrating the temperature-measuring system based on determined accuracy of the temperature-measuring system.