Test element analysis system

• US 7,262,061 B2
• Filed: 12/08/2000
• Issued: 08/28/2007
• Est. Priority Date: 12/24/1999
• Status: Expired

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Asfour, Jean-Michel, Petrich, Wolfgang, Kocherscheidt, Gerrit, Schmid, Wilfried
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US10/168,959
• Publication Number:
  US 20030157724A1
• Time in Patent Office: 2,454 Days
• Field of Search: 436/164, 436/356, 436/169, 422/87
• US Class Current: 436/169
• 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

Test element analysis system for the analytical investigation of a sample, in particular of a body liquid of human beings or animals, comprising test elements (2) with a carrier film (5) and a test field (7) fixed to the flat side (6) of the carrier film (5), the test field (7) containing a reagent system the reaction of which with the sample (21) leads to an optically measurable change in the detection zone (24) which is characteristic for the analysis, and an evaluation instrument with a measuring device for measuring the optically measurable change. In order to obtain a very high measuring accuracy and an easy handling at the same time, the carrier film (5) of the test element (2) comprises a light guide layer (26), the detection zone (24) of the test field (7) is in optical contact to the light guide layer (26) in a coupling out zone (33), enabling the coupling out of light from the light guide layer (26) to the detection zone (24), the primary light (29) of the light emitter (16) is coupled into the entry surface (31) in the light guide layer (26) in such a manner that a light guide section (32) of the light path of the primary light (29) runs between the entry surface and the detection zone (24) inside the carrier film (5), and the secondary light is reflected from the detection zone (24) into the light guide layer (26) in such a manner that a light guide section (34) of the light path of the secondary light runs between the detection zone (24) and the detector (17) inside the light guide layer (26).

Claims

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

a test element including a carrier film having at least one flat side and a test field secured to the flat side, the test field configured to be contacted, in order to perform an analysis, with a liquid sample in such a manner that liquid sample components penetrate into the test field, wherein the test field contains a reagent system the reaction of which with at least one component of the sample causes an optically measurable change in a detection zone located on a side of the test field directed towards the carrier film, said optically measurable change being characteristic for the analysis; and

an evaluation instrument including a test element holder for positioning a test element in a measuring position, and a measuring device for measuring the optically measurable change in the detection zone, the measuring device including a light emitter for irradiating primary light onto the detection zone, and a detector for detecting secondary light diffusely reflected from the detection zone;

wherein the carrier film comprises a light guide layer and a coupling out zone, the carrier film having an elongated, strip-shaped form and the light guide layer extending along the longitudinal dimension of the carrier film, the coupling out zone being a part of the flat side of the carrier film to which the test field is fixed and within which the detection zone of the test field is in optical contact with the carrier film in such a manner that light is coupled out from the light guide layer into the detection zone; and

wherein the primary light of the light emitter is coupled into the light guide layer via an entry surface, in such a manner that the light guide layer provides a light guide section for the light path of the primary light between the entry surface and the detection zone running inside the interior of the light guide layer; and

wherein secondary light which is diffusely reflected from the detection zone is reflected into the light guide layer and the light guide layer provides a light guide section for the light path of the secondary light running inside the carrier film between the detection zone and the detector; and

wherein the test field contains components causing strong optical scattering; and

wherein the scattering coefficient of the detection zone is at least ten times greater than the absorption coefficient.

2. The test element according to claim 1 wherein a side of the 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.

3. The test element according to claim 1 wherein the side of the light guide layer which 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 light guide section for the secondary light.

4. 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 light guide layer in the coupling out zone.

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

6. The test element according to claim 5 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.

7. The test element according to claim 6 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the primary light guide and having a refraction index which is lower than the refraction index of the primary light guide, a second partial layer being adjacent to the secondary light guide and having a refraction index which is lower than the refraction index of the secondary light guide, and a third partial layer running between the first partial layer and the second partial layer and being metallically reflecting.

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

a carrier film having at least one flat side and comprising a light guide layer, the carrier film having an elongated, strip-shaped form and the light guide layer extending along the longitudinal dimension of the carrier film; and

a test field secured to the flat side, the test field configured to be contacted, in order to perform an analysis, with a sample in such a manner that liquid sample components penetrate into the test field, wherein the test field contains a reagent system, the reaction of which with components of the liquid sample causes an optically measurable change in a detection zone which is a part of the test field, the optically measurable change being characteristic for the analysis, and wherein primary light irradiated onto the detection zone is diffusely reflected therefrom;

wherein the carrier film comprises a coupling out zone which is a part of the flat side of the carrier film to which the test field is fixed and within which the detection zone of the test field is in optical contact with the carrier film in such a manner that light is coupled out from the light guide layer into the detection zone; and

wherein the light guide layer comprises an entry surface for coupling in primary light in such a manner that the light guide layer provides a light guide section for the light path of the primary light coupled into the light guide layer running inside the light guide layer between the entry surface and the detection zone; and

wherein secondary light which is diffusely reflected from the detection zone is reflected into the light guide layer, and the light guide layer provides a light guide section for the light path of the secondary light running from the detection zone inside the carrier film; and

wherein the test field contains test field components causing strong optical scattering; and

wherein the scattering coefficient of the detection zone is at least ten times greater than the absorption coefficient.

9. The test element according to claim 8 wherein a side of the 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.

10. The test element according to claim 8 wherein the side of the light guide layer which 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 light guide section for the secondary light.

11. The test element according to claim 8 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 light guide layer in the coupling out zone.

12. The test element according to claim 8 wherein the carrier film comprises two light guide layers, wherein the primary light is coupled into a first light guide layer serving as a primary light guide, and the secondary light from the detection zone is coupled into a second light guide layer serving as a secondary light guide, each light guide layer extending along the longitudinal dimension of the carrier film.

13. The test element according to claim 12 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.

14. The test element according to claim 13 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the primary light guide and having a refraction index which is lower than the refraction index of the primary light guide, a second partial layer being adjacent to the secondary light guide and having a refraction index which is lower than the refraction index of the secondary light guide, and a third partial layer running between the first partial layer and the second partial layer and being metallically reflecting.

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

a carrier film comprising a light guide layer, the carrier film having an elongated, strip-shaped form and the light guide layer extending along the longitudinal dimension of the carrier film; and

a test field secured to the carrier film, the test field configured to be contacted, in order to perform an analysis, with a sample in such a manner that liquid sample components penetrate into the test field;

wherein the test field contains a reagent system, the reaction of which with components of the sample causes an optically measurable change in a detection zone which is a part of the test field, the optically measurable change being characteristic for the analysis; and

wherein the light guide layer comprises an entry surface for coupling in primary light and is configured to pass primary light from the entry surface through the light guide layer onto the detection zone, thereby irradiating at least a part of the detection zone and causing secondary light to be diffusely reflected from the detection zone; and

wherein the light guide layer or a second light guide layer is configured to pass secondary light from the detection zone to a detector; and

wherein the test field contains test field components causing strong optical scattering; and

wherein the scattering coefficient of the detection zone is at least ten times greater than the absorption coefficient.

16. The test element according to claim 15 wherein a side of the 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.

17. The test element according to claim 15 wherein the side of the light guide layer which 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 light guide section for the secondary light.

18. The test element according to claim 15 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 light guide layer in the coupling out zone.

19. The test element according to claim 15 wherein the carrier film comprises two light guide layers, wherein the primary light is coupled into a first light guide layer serving as a primary light guide, and the secondary light from the detection zone is coupled into a second light guide layer serving as a secondary light guide, each light guide layer extending along the longitudinal dimension of the carrier film.

20. The test element according to claim 19 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.

21. The test element according to claim 20 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the primary light guide and having a refraction index which is lower than the refraction index of the primary light guide, a second partial layer being adjacent to the secondary light guide and having a refraction index which is lower than the refraction index of the secondary light guide, and a third partial layer running between the first partial layer and the second partial layer and being metallically reflecting.

22. A method for the analytical investigation of a liquid sample, comprising:

providing a test element including a carrier film having at least one flat side and a light guide layer, the carrier film having an elongated, strip-shaped form and the light guide layer extending along the longitudinal dimension of the carrier film; and

a test field secured to the flat side, the test field configured to be contacted, in order to perform an analysis, with a sample in such a manner that liquid sample components penetrate into the test field, wherein the test field contains a reagent system, the reaction of which with components of the liquid sample causes an optically measurable change in a detection zone which is a part of the test field, the change being characteristic for the analysis, and wherein primary light irradiated onto the detection zone is diffusely reflected therefrom;

wherein the carrier film comprises a coupling out zone which is a part of the flat side of the carrier film to which the test field is fixed and within which the detection zone of the test field is in optical contact with the carrier film in such a manner that light is coupled out from the light guide layer into the detection zone;

wherein the test field contains test field components causing strong optical scattering; and

wherein the scattering coefficient of the detection zone is at least ten times greater than the absorption coefficient;

illuminating at least a part of the detection zone by passing primary light from a light emitter into the light guide layer, wherein the primary light emitted from the light emitter is coupled into the light guide layer through an entry surface; and

wherein the coupled in primary light is guided inside the light guide layer to the coupling out zone where it is coupled out in such a manner that it illuminates at least a part of the detection zone, thereby generating secondary light by diffuse reflection of the primary light in the detection zone; and

detecting a characteristic of the detection zone by passing the secondary light into contact with a detector;

wherein the secondary light generated by diffuse reflection in the detection zone is transported inside the light guide layer towards the detector and the secondary light is coupled out from the light guide layer towards the detector.

23. The test element according to claim 22 wherein a side of the 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.

24. The test element according to claim 22 wherein the side of the light guide layer which 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 light guide section for the secondary light.

25. The test element according to claim 22 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 light guide layer in the coupling out zone.

26. The test element according to claim 22 wherein the carrier film comprises two light guide layers, wherein the primary light is coupled into a first light guide layer serving as a primary light guide, and the secondary light from the detection zone is coupled into a second light guide layer serving as a secondary light guide, each light guide layer extending along the longitudinal dimension of the carrier film.

27. The test element according to claim 26 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.

28. The test element according to claim 27 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the primary light guide and having a refraction index which is lower than the refraction index of the primary light guide, a second partial layer being adjacent to the secondary light guide and having a refraction index which is lower than the refraction index of the secondary light guide, and a third partial layer running between the first partial layer and the second partial layer and being metallically reflecting.