Devices and methods of determining disturbance variable-corrected analyte concentrations

• US 9,599,552 B2
• Filed: 10/17/2014
• Issued: 03/21/2017
• Est. Priority Date: 04/19/2012
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Baldus, Susanne, Schulat, Jochen, Trick, Sebastian
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US14/516,653
• Publication Number:
  US 20150037898A1
• Time in Patent Office: 886 Days
• Field of Search: 436/70, 436/93, 436/95, 436/164, 436/169, 436/171, 436/180, 435/14, 435/287.1, 435/287.7, 435/288.7, 422/400, 422/420, 422/68.1, 422/73, 422/82.05, 422/82.09, 422/502, 422/507
• US Class Current: 1/1
• CPC Class Codes: G01N 21/272 for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
• 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 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Devices and methods are provided for determining concentration of at least one analyte in a body fluid sample such as blood, especially a blood glucose concentration. In the methods, a test element is provided that has at least one reagent element configured so as to carry out at least one optically detectable detection reaction in the presence of the analyte. The body fluid sample is applied to the test element and a time course of at least one optical measurement variable of the reagent element is detected. At least one first time interval of the time course of the optical measurement variable is used to determine at least one disturbance variable value in the body fluid sample, in particular a concentration of a disturbance variable such as hematocrit. At least one second time interval of the time course is used to determine analyte concentration. The at least one disturbance variable value can be used to correct/compensate the analyte concentration.

Claims

1. A method of determining at least one analyte concentration in a body fluid sample, the method comprising the steps of:

providing at least one test element that comprises at least one reagent element configured for at least one optically detectable detection reaction in the presence of the analyte;

applying the body fluid sample to the test element;

detecting a time course of at least one optical measurement variable of the reagent element;

determining at least one disturbance variable value in the body fluid sample from at least one first time interval of the time course of the at least one optical measurement variable; and

determining the at least one analyte concentration from at least one second time interval of the time course of the at least one optical measurement variable,

wherein a time interval is a quantity of measurement time points comprising at least two measurement time points,

wherein during the detecting of the time course of the at least one optical measurement variable in the first time interval and the second time interval, the reagent element is irradiated by at least one interrogating light beam from at least one interrogating light source, and wherein at least one response light beam from the reagent element is detected by at least one detector, and wherein the time course of at least one optical measurement variable in the first time interval includes a sudden wetting-induced change in the optical measurement variable.

2. The method as claimed in claim 1, wherein the first time interval is an initial time interval of the time course, and wherein the second time interval is subsequent to the first time interval.

3. The method of claim 1, wherein the at least one optical measurement variable is determined at at least one first wavelength, and wherein a wetting time point at which the body fluid sample reaches and wets the reagent element is determined from a change in the optical measurement variable after the body fluid sample is applied to the test element.

4. The method of claim 1, wherein at least one correction or compensation is ascertained by means of the disturbance variable value, and wherein a corrected at least one analyte concentration is ascertained from the second time interval taking into account the correction or compensation.

5. The method of claim 1, wherein a change in the at least one optical measurement variable in the second time interval is detected, and wherein the optical measurement variable determined at a time point at which a temporal change in the optical measurement value was below a preset threshold value is used to determine the at least one analyte concentration.

6. The method of claim 1, wherein the body fluid sample is blood and is applied to at least one application site on the test element, wherein the blood or components thereof are transferred from the application site to the reagent element, and wherein the at least one analyte concentration is a glucose concentration.

7. The method of claim 6, wherein the disturbance variable value is a hematocrit value.

8. The method of claim 1, wherein the at least one optical measurement variable is a reflectance value.

9. A method of determining at least one analyte concentration in a body fluid sample, the method comprising the steps of:

providing at least one test element that comprises at least one reagent element configured for at least one optically detectable detection reaction in the presence of the analyte;

applying the body fluid sample to the test element;

detecting a time course of at least one optical measurement variable of the reagent element;

determining at least one disturbance variable value in the body fluid sample from at least one first time interval of the time course of the at least one optical measurement variable; and

determining the at least one analyte concentration from at least one second time interval of the time course of the at least one optical measurement variable,

wherein a time interval is a quantity of measurement time points comprising at least two measurement time points,

wherein during the detecting of the time course of the at least one optical measurement variable in the first time interval and the second time interval, the reagent element is irradiated by at least one interrogating light beam from at least one interrogating light source, and wherein at least one response light beam from the reagent element is detected by at least one detector, wherein the interrogating light beam has a same wavelength and/or a same spectral properties in the first time interval and the second time interval.

10. The method of claim 9, wherein the response light beam has one or both of the same wavelength and the same spectral properties in the first time interval and the second time interval.

11. A device for determining at least one analyte concentration in a body fluid sample, the device comprising:

at least one test element, wherein the test element has at least one reagent element configured for at least one optically detectable detection reaction in the presence of the at least one analyte, and wherein the body fluid sample may be applied to the test element;

at least one interrogating light source for providing at least one interrogating light beam;

at least one optical detection device, wherein the optical detection device is configured for detecting a time course of at least one optical measurement variable of the reagent element;

at least one evaluation device, wherein the evaluation device is configured for determining at least one disturbance variable value in the body fluid sample from at least one first time interval of the time course of the at least one optical measurement variable, and wherein the evaluation device is further configured for determining the at least one analyte concentration from at least one second time interval of the time course, wherein a time interval is a quantity of measurement time points comprising at least two measurement time points,

wherein during the detecting of the at least one optical measurement variable in the first time interval and the second time interval, the reagent element is irradiated by the at least one interrogating light beam from the at least one interrogating light source, and wherein at least one response light beam from the reagent element is detected by at least one optical detection device, and

wherein the time course of the optical measurement variable in the first time interval includes a sudden wetting-induced change in the optical measurement variable.

12. The device of claim 11, wherein the test element is a test strip and the device further comprises at least one test strip holder, wherein at least one test strip in the at least one test strip holder can be placed in an application position, wherein in the application position, a user can apply the body fluid sample to at least one application site of the test strip, and

wherein the test strip further comprises at least one capillary element for transferring the body fluid sample or components thereof from the at least one application site to the reagent element.

13. The device of claim 12, wherein at least one separating element for separating at least one component from the body fluid sample is configured between the capillary element and the reagent element.

14. The device of claim 11, wherein the body fluid sample is blood, and wherein the at least one analyte concentration is a glucose concentration.

15. The device of claim 14, wherein the disturbance variable value is a hematocrit value.

16. The device of claim 14, wherein the at least one evaluation device is further configured for using the disturbance variable value to correct or compensate the glucose concentration.

17. The device of claim 11, wherein the at least one optical measurement variable is a reflectance value.

18. A device for determining at least one analyte concentration in a body fluid sample, the device comprising:

at least one test element, wherein the test element has at least one reagent element configured for at least one optically detectable detection reaction in the presence of the at least one analyte, and wherein the body fluid sample may be applied to the test element;

at least one interrogating light source for providing at least one interrogating light beam;

at least one optical detection device, wherein the optical detection device is configured for detecting a time course of at least one optical measurement variable of the reagent element;

at least one evaluation device, wherein the evaluation device is configured for determining at least one disturbance variable value in the body fluid sample from at least one first time interval of the time course of the at least one optical measurement variable, and wherein the evaluation device is further configured for determining the at least one analyte concentration from at least one second time interval of the time course, wherein a time interval is a quantity of measurement time points comprising at least two measurement time points,

wherein during the detecting of the at least one optical measurement variable in the first time interval and the second time interval, the reagent element is irradiated by the at least one interrogating light beam from the at least one interrogating light source, and wherein at least one response light beam from the reagent element is detected by at least one optical detection device, wherein the at least one optical detection device is configured for detecting the at least one optical measurement variable in the first time interval and the second time interval at the same wavelength.