Test element analysis system

• US 8,535,609 B2
• Filed: 06/27/2007
• Issued: 09/17/2013
• Est. Priority Date: 12/24/1999
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Petrich, Wolfgang, Schmid, Wilfried, Kocherscheidt, Gerrit, Asfour, Jean-Michel
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US11/769,438
• Publication Number:
  US 20080180652A1
• Time in Patent Office: 2,274 Days
• Field of Search: 422/82.05, 422/87, 436/169, 356/36, 356/432
• US Class Current: 422/82.05
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• 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 test element analysis system for the analytical investigation of a liquid sample. The test element comprising a carrier film having a first light guide layer having a flat side, a second light guide layer positioned adjacent to the first light guide layer and opposite of the flat side, and a coupling out zone which is part of the flat side of the first light guide layer. A test field is secured to the flat side and is constructed and arranged to receive a liquid sample. The test field comprises a reagent system having a soluble reagent capable of causing an optically measurable change upon reaction with an analyte of the liquid sample, and a detection zone in optical contact with the coupling out zone.

Claims

1. A test element for the analytical investigation of a liquid sample, comprising:

a carrier film having an elongated, strip-shaped form, the carrier film comprising;

a first light guide layer having a flat side and an opposed second side, said first light guide layer further comprising an entry surface for coupling in primary light,

a second light guide layer positioned adjacent to the second side of said first light guide layer and opposite of the flat side, the second light guide layer extending along the longitudinal dimension of the first light guide layer, and

a coupling out zone which is part of the flat side of the first light guide layer; and

a test field secured to the flat side of the first light guide layer, the test field constructed and arranged to receive a liquid sample, wherein liquid sample components penetrate into the test field, the test field comprising;

a reagent system comprising a soluble reagent capable of causing an optically measurable change upon reaction with an analyte of the liquid sample, the optically measurable change being characteristic for the analysis, and

a detection zone in optical contact with the coupling out zone in such a manner that the primary light is coupled out from the first light guide layer into the detection zone such that the primary light illuminates the detection zone, the optically measurable change being measured by illuminating the detection zone with the primary light and detecting an intensity of secondary light, said secondary light comprising light that has been reflected at the detection zone;

wherein the entry surface couples in primary light in such a manner that the first light guide layer provides a first light guide section for the light path of the primary light coupled into the first light guide layer from the entry surface toward the detection zone, the first light guide section running inside the first light guide layer along the longitudinal dimension of the carrier film;

and wherein the secondary light is reflected from the detection zone and into the second light guide layer, and the second light guide layer is constructed and arranged to provide a second light guide section for the light path of the secondary light away from the detection zone, the second light guide section running along the longitudinal dimension of the carrier film and adjacent to the first light guide section.

2. The test element according to claim 1 wherein the reagent system is adapted for the analysis of a body liquid of human beings or of animals.

3. The test element according to claim 1 wherein the carrier film comprises a plastic material.

4. The test element according to claim 1 wherein the detection zone is located on a side of the test field directed towards the carrier film.

5. The test element according to claim 1 wherein the second side of the first light guide layer opposed to the coupling out zone is adapted, at least in sections thereof, to cause a change of the light propagation direction of the primary light towards the detection zone.

6. The test element according to claim 1 wherein a second side of the second light guide layer is opposed to the detection zone is adapted, at least in sections thereof, to cause a change of the propagation direction of secondary light diffusely reflected from the detection zone, to coincide with the direction of the second light guide section for the secondary light.

7. The test element according to claim 1 wherein the test field is sufficiently absorbent to transport liquid sample components in the coupling out zone to the flat side of the carrier film to which the test field is secured in such a manner that the liquid sample components wet the first light guide layer in the coupling out zone.

8. The test element according to claim 1 wherein the first light guide layer in the coupling out zone is roughened in order to improve the coupling out of the primary light.

9. The test element according to claim 1 wherein the test field contains test field components causing strong optical scattering.

10. The test element according to claim 1 wherein the primary light is coupled into the first light guide layer serving as a primary light guide, and the secondary light from the detection zone is coupled into the second light guide layer serving as a secondary light guide, each light guide layer extending along the longitudinal dimension of the carrier film.

11. The test element according to claim 1 wherein the first light guide layer and the second light guide layer are separated, at least on a part of their length, by an optical barrier.

12. The test element according to claim 11 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the first light guide layer and having a refraction index which is lower than the refraction index of the first light guide layer, a second partial layer being adjacent to the second light guide layer and having a refraction index which is lower than the refraction index of the second light guide layer, and a third partial layer running between the first partial layer and the second partial layer and being metallically reflecting.

13. The test element according to claim 1 wherein the optically measurable change is a color change in the detection zone.

14. The test element of claim 1 in which the carrier film includes a first end and a second end, the entry surface being closer to the first end and the coupling out zone and test field being closer to the second end.

15. A test element for the analytical investigation of a liquid sample, comprising:

a carrier film having an elongated, strip-shaped form, the carrier film comprising;

a first light guide layer having a longitudinal dimension extending from a first end to a second end, the first light guide layer including a first flat side and an opposed second side, the first light guide layer further comprising an entry surface closer to the first end and a coupling out zone along the first side of the first light guide layer closer to the second end, and

a second light guide layer positioned adjacent to the second side of the first light guide layer and opposite from the flat side of the first light guide layer, the second light guide layer extending along the longitudinal dimension of the first light guide layer, and

a test field secured to the first side of the first light guide layer adjacent the coupling out zone, the test field comprising;

a reagent system comprising a soluble reagent capable of causing an optically measurable change upon reaction with an analyte of the liquid sample, the optically measureable change being characteristic for the analysis, and

a detection zone in optical contact with the coupling out zone of the first light guide layer;

the first light guide layer being positioned between the test field and the second light guide layer and configured and adapted to propagate light from the test field into the second light guide layer.

16. The test element of claim 15 in which the first end of the first light guide layer includes an end face extending between the sides, the end face of the first light guide layer comprising the entry surface.

17. The test element of claim 15 in which the coupling out zone comprises the first guide layer having a roughened surface.

18. The test element of claim 15 in which the first light guide layer includes a primary light guidance means for directing light traveling in the direction from the first end to the second end into a direction toward the test field.

19. The test element of claim 18 in which the primary light guidance means comprises the first light guide layer including a primary inclined surface.

20. The test element of claim 19 in which the primary inclined surface is polished or metallic.

21. The test element of claim 15 in which the second light guide layer extends from a first end to a second end, the second light guide layer including a secondary light guidance means closer to the second end than the first end for directing light traveling in the direction from the test field to the second light guide layer into a direction from the second end of the second light guide layer to the first end of the second light guide layer.

22. The test element of claim 21 in which the secondary light guidance means comprises the second light guide layer including a secondary inclined surface.

23. The test element of claim 22 in which the secondary inclined surface is polished or metallic.

24. The test element of claim 21 in which the first light guide layer includes a primary light guidance means for directing light traveling in the direction from the first end to the second end into a direction toward the test field.

25. The test element of claim 24 in which the primary light guidance means comprises the first light guide layer including a primary inclined surface.

26. The test element of claim 24 in which the secondary light guidance means comprises the second light guide layer including a secondary inclined surface.

27. The test element of claim 26 in which the primary light guidance means comprises the first light guide layer including a primary inclined surface.

28. The test element of claim 27 in which the primary inclined surface and the secondary inclined surface are parallel.

29. The test element of claim 28 in which the primary and secondary inclined surfaces are polished or metallic.

30. The test element of claim 15 in which the second light guide layer extends from a first end to a second end, the second light guide layer including a coupling out zone closer to the first end of the second light guide layer.

31. The test element of claim 30 in which the second light guide layer includes a coupling out light guidance means for directing light traveling in the direction from the second end of the second light guide layer to the first end of the second light guide layer into a direction to the outside of the second light guide layer.

32. The test element of claim 31 in which the coupling out light guidance means comprises the second light guide layer including a coupling out inclined surface adjacent the first end.

33. The test element of claim 32 in which the coupling out inclined surface is polished or metallic.