Integrated test element

• US 20090061076A1
• Filed: 08/29/2008
• Published: 03/05/2009
• Est. Priority Date: 03/02/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rosicke, Bernd, Gassler-Dietsche, Claudia, Hebestreit, Kai, Wehowski, Frederic
• Granted Patent: US 8,242,461 B2
• Time in Patent Office: Days
• US Class Current: 427/66
• CPC Class Codes: G01N 21/255 Details, e.g. use of specially adapted sources, lighting or optical systems
• 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 2201/0628 Organic LED [OLED]

Abstract

An integrated test element (110) is proposed for detecting for detecting at least one analyte in a sample (142), in particular in a liquid sample (142). The integrated test element (110) has a carrier element (112), with an application face (114) on which at least one organic electroluminescent component (126) is applied. Furthermore, at least one indicator substance (136) is applied on the application face (114), which indicator substance (136) alters at least one optical characteristic, in particular an emission characteristic (e.g. a fluorescence characteristic), when it comes into contact with the at least one analyte. Furthermore, the integrated test element (110) has at least one photodetector element (116).

Claims

1. An integrated test element for detecting at least one analyte in a sample, in particular in a liquid sample, comprising:

a carrier element, wherein at least one organic electroluminescent component, in particular at least one organic electroluminescent thin-film component, in particular at least one organic light-emitting diode (OLED), is applied on an application face of the carrier element, wherein the integrated test element furthermore comprises at least one photodetector element, wherein the integrated test element comprises at least one indicator substance on the application face, wherein the at least one organic electroluminescent component is designed in such a way that at least some of the excitation light emitted by it reaches the at least one indicator substance, wherein the at least one indicator substance is designed to alter at least one optical characteristic, in particular an emission characteristic, in particular a fluorescence characteristic, when the at least one indicator substance comes into contact with the at least one analyte, wherein the integrated test element furthermore comprises at least one reference device which is designed to alter at least one optical characteristic, in particular at least one of a reflection characteristic and an emission characteristic, in particular a fluorescence characteristic, depending on the intensity of the excitation light emitted by the at least one organic electroluminescent component, and wherein the alteration of the at least one optical characteristic is at least substantially independent of the presence or absence of the at least one analyte.

2. The integrated test element as claimed in claim 1, wherein the at least one photodetector element includes at least one organic thin-film photodetector element.

3. The integrated test element as claimed in claim 1, wherein the at least one photodetector element is arranged on the application face.

4. The integrated test element as claimed in claim 1, wherein the at least one indicator substance is at least partially in direct physical contact with the at least one organic electroluminescent component and the at least one indicator substance is at least one of bordering the at least one organic electroluminescent component and partially identical to the at least one organic electroluminescent component.

5. The integrated test element as claimed in claim 4, wherein the at least one indicator substance is at least partially integrated, in particular at least one of merged and chemically bound, into at least one organic layer of the at least one organic electroluminescent component.

6. The integrated test element as claimed in claim 1, wherein the at least one carrier element includes one or more of a needle-shaped, cannula-shaped and lancet-shaped part for at least one of piercing of and insertion into a body tissue.

7. The integrated test element as claimed in claim 1, wherein the excitation light emitted by the at least one organic electroluminescent component is at least partially prevented from reaching the at least one photodetector element.

8. The integrated test element as claimed in claim 7, further including one or more of an optical filter element and a light-blocker element.

9. The integrated test element as claimed in claim 1, wherein the at least one reference device includes at least one or both of a reflector and a reference fluorophore, in particular at least one or both of a paper brightener and a metal oxide, in particular TiO₂.

10. The integrated test element of claim 1, wherein at least one of the organic electroluminescent component and the photodetector element is composed of several individual organic electroluminescent components or photodetector elements, respectively, in particular of at least one matrix of such components.

11. The integrated test element of claim 1, wherein the at least one organic electroluminescent component and the at least one photodetector element are arranged in the same layer plane on the carrier element.

12. The integrated test element as claimed in claim 1, further comprising:

an additional barrier layer that at least partially covers the integrated test element, said barrier layer including at least one of the following properties;

an impermeability to the at least one indicator substance;

an at least partial permeability to the sample; and

an action separating the sample at least partially into its constituents.

13. An integrated test element for detecting at least one analyte in a sample, in particular in a liquid sample, comprising:

a carrier element, wherein at least one organic electroluminescent component, in particular at least one organic electroluminescent thin-film component, in particular at least one organic light-emitting diode (OLED), is applied on an application face of the carrier element, wherein the integrated test element furthermore comprises at least one photodetector element, wherein the integrated test element comprises at least one indicator substance on the application face, wherein the at least one organic electroluminescent component is designed in such a way that at least some of the excitation light emitted by it reaches the at least one indicator substance, wherein the at least one indicator substance is designed to alter at least one optical characteristic, in particular an emission characteristic, in particular a fluorescence characteristic, when the at least one indicator substance comes into contact with the at least one analyte, and wherein the at least one carrier element includes one or more needle-shaped, cannula-shaped, and lancet-shaped parts for at least one of piercing of and insertion into a body tissue.

14. An integrated test element for detecting at least one analyte in a sample, in particular a liquid sample, comprising:

a carrier element, wherein at least one organic electroluminescent component, in particular at least one organic electroluminescent thin-film component, in particular at least one organic light-emitting diode (OLED), is applied on an application face of the carrier element, wherein the integrated test element further comprises at least one photodetector element, wherein the integrated test element comprises at least one indicator substance on the application face, wherein the at least one organic electroluminescent component is designed in such a way that at least some of the excitation light emitted by it reaches the at least one indicator substance, wherein the at least one indicator substance is designed to alter at least one optical characteristic, in particular an emission characteristic, in particular a fluorescence characteristic, when the at least one indicator substance comes into contact with the at least one analyte, wherein the at least one indicator substance is at least partially in direct physical contact with the at least one organic electroluminescent and the at least one indicator substance is at least one of bordering the at least one organic electroluminescent component and partially identical to the at least one organic electroluminescent component, and wherein the at least one indicator substance is at least partially integrated, in particular at least one of merged and chemically bound, into at least one organic layer of the at least one organic electroluminescent component.

18. A method for producing the integrated test element of claim 14, comprising the following method steps:

applying the at least one organic electroluminescent component, in particular the at least one organic electroluminescent thin-film component, in particular the at least one organic light-emitting diode (OLED) on an application face of a carrier element;

applying the at least one photodetector element, in particular the at least one organic thin-film photodetector element on the carrier element, in particular on the application face of the carrier element; and

applying the at least one indicator substance on the application face of the carrier element, wherein the at least one indicator substance is designed to alter at least one optical characteristic, in particular an emission characteristic, in particular a fluorescence characteristic, when the at least one indicator substance comes into contact with the at least one analyte.

19. The method as claimed in claim 18, wherein at least one of the following method steps is used:

incorporating the at least one indicator substance into at least one starting substance for producing at least one organic layer of the at least one organic electroluminescent component; and

applying the at least one indicator substance by simultaneous or sequential application from at least one of the liquid phase and the gas phase, in particular by co-evaporation, with at least one starting substance for producing at least one organic layer of the at least one organic electroluminescent component.

15. A test system for detecting at least one analyte in a sample, in particular in a liquid sample, comprising:

at least one integrated test element including a carrier element, wherein at least one organic electroluminescent component, in particular at least one organic electroluminescent thin-film component, in particular at least one organic light-emitting diode (OLED), is applied on an application face of the carrier element, wherein the integrated test element furthermore comprises at least one photodetector element, wherein the integrated test element comprises at least one indicator substance on the application face, wherein the at least one organic electroluminescent component is designed in such a way that at least some of the excitation light emitted by it reaches the at least one indicator substance, wherein the at least one indicator substance is designed to alter at least one optical characteristic, in particular an emission characteristic, in particular a fluorescence characteristic, when the at least one indicator substance comes into contact with the at least one analyte, wherein the integrated test element furthermore comprises at least one reference device which is designed to alter at least one optical characteristic, in particular at least one of a reflection characteristic and an emission characteristic, in particular a fluorescence characteristic, depending on the intensity of the excitation light emitted by the at least one organic electroluminescent component, and wherein the alteration of the at least one optical characteristic is at least substantially independent of the presence or absence of the at least one analyte; and

at least one control and evaluation electronics unit with means for controlling the at least one organic electroluminescent component, means for reading out the at least one photodetector element, and means for calculating at least one analyte concentration from a known correlation between the alteration of the at least one optical characteristic of the at least one indicator substance and the concentration of the at least one analyte.

16. The test system as claimed in claim 15, wherein the at least one control and evaluation electronics unit further includes at least one correction electronics unit, wherein the at least one correction electronics unit is designed to correct the calculation of the at least one analyte concentration in accordance with information generated by means of the at least one reference device.

17. The test system as claimed in claim 16, wherein the at least one control and evaluation electronics unit is designed at least partially as an organic electronic circuit, in particular as a circuit with at least one organic thin-film transistor.