METHOD AND ASSEMBLY FOR DETERMINING THE TEMPERATURE OF A TEST SENSOR

• US 20100309947A1
• Filed: 06/08/2010
• Published: 12/09/2010
• Est. Priority Date: 06/08/2009
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Mu, Wu, Sun, Hoi-Cheong Steve, Parasnis, Narasinha
• Granted Patent: US 8,801,273 B2
• Time in Patent Office: Days
• US Class Current: 374/1
• 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 device for determining an analyte concentration in a fluid sample, comprising:

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

a measurement system that measures the reaction between the reagent and the analyte;

a temperature-measuring system that measures the test sensor temperature when the test sensor is received into the receiving port, a concentration of the analyte in the fluid sample being determined according to the measurement of the reaction and the measurement of the test sensor temperature; and

a diagnostic system that determines an accuracy of the temperature-measuring system.

2. The device of claim 1, wherein the diagnostic system includes a reference object that achieves at least one reference temperature, the temperature-measuring system measuring at least one test temperature for the reference object when the reference object achieves the at least one reference temperature, and the diagnostic system determining the accuracy of the temperature-measuring system by comparing the at least one test temperature to the corresponding reference temperature.

3. The device of claim 2, wherein the diagnostic system includes a resistor that receives a specified current to achieve the at least one reference temperature.

4. The device of claim 2, wherein the reference object is disposed on a calibration device that is removably inserted into the receiving port.

5. The device of claim 4, wherein the calibration device includes a heating element that heats the reference object to the at least one reference temperature, and the reference object is disposed on a flange extending from the heating element.

6. The device of claim 1, wherein the temperature-measuring system includes a thermopile sensor that determines a temperature measurement by measuring infrared radiation.

7. The device of claim 6, wherein the diagnostic system includes a reference object that is disposed in a field of view of the thermopile sensor and achieves at least one reference temperature, the temperature-measuring system measuring at least one test temperature for the reference object, and the diagnostic system determining the accuracy of the temperature-measuring system by comparing the at least one test temperature to the corresponding reference temperature.

8. The device of claim 7, wherein the diagnostic system includes a heating element being coupled to the thermopile sensor, the heating element heating the reference object to the reference temperature and heating a body of the thermopile sensor to a sensor temperature, whereby an obstruction in the field of view of the thermopile sensor and in contact with the body of the thermopile sensor causes the test temperature to be higher than the reference temperature.

9. The device of claim 1, wherein the temperature-measuring assembly includes an optical-sensing system configured to detect a temperature according to a thermochromic material.

10. The device of claim 9, wherein the diagnostic system includes a reference object that is disposed in a field of view of the optical sensing and achieves at least one reference temperature, the thermochromic material being disposed on the reference object, the temperature-measuring system measuring at least one test temperature for the reference object, and the diagnostic system determining the accuracy of the temperature-measuring system by comparing the at least one test temperature to the corresponding reference temperature.

11. The device of claim 1, further comprising a processor that determines the concentration of the analyte in the fluid sample according to the measurement of the reaction and the measurement of the test sensor temperature, wherein the processor adjusts the test sensor temperature measured by the temperature-measuring system according to the accuracy of the temperature-measuring system.

12. A method for testing a meter, the meter determining an analyte concentration in a fluid sample collected on a test sensor by measuring a reaction between the analyte and a reagent on the test sensor, the meter including a temperature-measuring system that determines a test sensor temperature, the meter using the test sensor temperature as a parameter in determining the analyte concentration, the method comprising the steps of:

changing a temperature of a reference object to a specified reference temperature, the reference object being positioned in the meter for measurement by the temperature-measuring system;

determining, with the temperature-measuring system, a test temperature for the reference object when the reference object achieves the reference temperature; and

determining an accuracy of the temperature-measuring system by comparing the test temperature to the reference temperature.

13. The method of claim 12, wherein changing the temperature of a reference object includes heating the reference object by delivering a specified current to a resistor.

14. The method of claim 12, further comprising removably inserting a calibration device a receiving port of the meter, the calibration device including the reference object and positioning the object in the meter for measurement by the temperature-measuring system.

15. The method of claim 14, wherein the calibration device include a heating element, and changing the temperature of a reference object includes heating the reference object with the heating element.

16. The method of claim 12, wherein determining a test temperature includes determining the test temperature by measuring infrared radiation from the reference object with a thermopile sensor.

17. The method of claim 16, wherein changing the temperature of a reference object includes heating the reference object with a heating element that is coupled to the thermopile sensor, the heating element heating the reference object to the reference temperature and heating a body of the thermopile sensor to a sensor temperature, whereby an obstruction in the field of view of the thermopile sensor and in contact with the body of the thermopile sensor causes the test temperature to be higher than the reference temperature.

18. The method of claim 12, wherein determining a test temperature includes determining, with an optical-sensing system, the test temperature according to a thermochromic material disposed on the reference object.

19. The method of claim 12, further comprising determining the concentration of the analyte in the fluid sample according to the reaction between the analyte and a reagent on the test sensor and the test sensor temperature measured by the temperature-measuring system.

20. The method of claim 12, further comprising adjusting the test sensor temperature measured by the temperature-measuring system according to the accuracy of the temperature-measuring system.