Measurement system with optical referencing

• US 8,173,439 B2
• Filed: 06/19/2009
• Issued: 05/08/2012
• Est. Priority Date: 12/20/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Petrich, Wolfgang, Hoenes, Joachim, Kraemer, Uwe
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US12/488,153
• Publication Number:
  US 20090304247A1
• Time in Patent Office: 1,054 Days
• Field of Search: 436/164, 382/128, 382/100
• US Class Current: 436/164
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• 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

Abstract

A system is described for determining the concentration of an analyte in a liquid by absorption measurement comprising a test element with a detection area which contains at least one reaction area with reagents for detecting the analyte which cause a change in the absorption behavior upon reaction with the analyte. The detection area contains at least one reference area in which the absorption behavior is substantially not changed when wetted by a sample having the analyte. Furthermore, the system contains a detection unit for the spatially resolved detection of light intensities which are received from the detection area and an evaluation unit for evaluating signals from the detection unit. Further embodiments of the system comprise reaction areas and reference areas arranged alternately in two dimensions.

Claims

1. A system for determining the concentration of an analyte in a liquid by absorption measurement, comprising a test element with a detection area which comprises at least one reaction area with reagents for detecting the analyte which cause a change in the absorption behavior in the reaction area upon reaction with the analyte, the detection area further comprising at least one reference area, the system further comprising a detection unit for the spatially resolved detection of light intensities which are received at least from a part of the detection area, and an evaluation unit for evaluating signals of the detection unit;

wherein the one or more reference areas are configured such that the absorption behavior does not substantially change upon wetting with the liquid having the analyte.

2. The system according to claim 1, wherein the detection area comprises a plurality of reaction areas and a plurality of reference areas on the same test element.

3. The system according to claim 2, wherein the reaction areas and the reference areas are arranged alternately in two dimensions.

4. The system according to claim 1, wherein the at least one reference area has a coating or impregnation configured to prevent penetration of the analyte from the liquid into the one or more reference areas.

5. The system according to claim 4, wherein the coating or impregnation is a membrane or a plastic or artificial resin.

6. The system according to claim 1, wherein a water-insoluble dye is formed in the one or more reaction areas when the analyte is present to prevent diffusion of the dye into the one or more reference areas.

7. The system according to claim 1, wherein the reagents contain at least one enzyme which reacts with the analyte.

8. The system according to claim 7, wherein the one or more reference areas contain no active enzyme.

9. The system according to claim 1, wherein the arrangement and/or shapes of the one or more reagent areas and of the one or more reference areas is generally random.

10. The system according to claim 1, wherein the one or more reaction areas and one or more reference areas have generally the same size and generally the same volume.

11. The system according to claim 1, wherein the area of at least one reaction area or of at least one reference area is less than 1 mm².

12. The system according to claim 1, wherein transmitted and/or reflected light is detected by the detection unit.

13. A test element for determining the concentration of an analyte in a body fluid by determining the optical density, comprising a detection area which contains a plurality of reaction areas including reagents and a plurality of reference areas;

wherein the reference areas are configured such that the optical density of each is substantially not changed when wetted by the body fluid having the analyte.

14. The test element according to claim 13, wherein the reaction areas and the reference areas are arranged alternately in two dimensions.

23. A method for detecting an analyte with a test element according to claim 13 comprising the steps of:

applying the sample to the detection area, performing a spatially resolved measurement of the reflected light intensities from the detection area, and determining the analyte concentration with the aid of the light intensities measured from at least one reaction area and from at least one reference area.

24. The method according to claim 23, wherein a sample volume of less than 500 nl is applied to the detection area of the test element.

15. A method for producing a test element for determining an analyte in a body fluid by measurement of an absorption behavior, comprising the steps of providing a support material, and applying a detection area on at least a portion of the support material, the detection area comprising at least one reaction area and at least one reference area;

wherein applying the detection area includes applying one or more reagents for detecting the analyte on the portion of the support material, said reagents for causing a change in the absorption behavior when wetted by the body fluid having the analyte; and

wherein the one or more reference areas are configured such that the absorption behavior of each is substantially not changed when wetted by the body fluid having the analyte.

16. The method according to claim 15, wherein the one or more reaction areas and the one or more reference areas are arranged alternately in two dimensions.

17. The method according to claim 16, wherein the arrangement and/or shape of each reagent area and of each reference area is generally random.

18. The method according to claim 15, wherein a printing process and/or a knife-coating process is used for applying the reagents.

19. The method according to claim 15, wherein the one or more reference areas are generated by one of irradiating a part of the reaction area with a laser and changing the chemical composition of a part of the reaction area.

20. The method according to claim 15, wherein the one or more reference areas are generated by at least some of the reagents being deactivated in the reference areas by one of laser irradiation and chemical treatment.

21. The method according to claim 15, wherein the one or more reference areas contain at least one substance less than the one or more reaction areas.

22. The method according to claim 15, wherein the one or more reference areas contain at least one additional substance than the one or more reaction areas, the substance generally preventing a reaction with the analyte.