Test element analysis system

• US RE44,788 E1
• Filed: 07/14/2009
• Issued: 03/04/2014
• Est. Priority Date: 12/24/1999
• Status: Expired due to Term

• 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:
  US12/502,789
• Time in Patent Office: 1,694 Days
• Field of Search: 422/82.11
• US Class Current: 422/82.11
• CPC Class Codes: N/A

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, the test element including a test field secured to the at least one 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 comprising a detection zone and a reagent system the reaction of which, the detection zone being located on a side of the test field directed towards the carrier film, the reagent system including a reagent which upon reaction of the reagent system with at least one component of the sample causes an optically measurable change in a the detection zone located on a side of the test field directed towards the carrier film, said optically measurable change being characteristic for the analysis, the test field having components causing strong optical scattering and diffusely reflecting light directed at the test field, the detection zone of the test field having a scattering coefficient and an absorption coefficient, and the scattering coefficient being at least ten times greater than the absorption coefficient; and

an evaluation instrument including a test element holder for positioning a the 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 comprising at least one light guide layer and a coupling out zone, the carrier film having an elongated, strip-shaped form and the at least one light guide layer extending along the a longitudinal dimension of the carrier film, the at least one light guide layer including an entry surface, a primary light guide section directing light inside the interior of the at least one light guide layer from the entry surface to the detection zone, and a secondary light guide section directing light inside the interior of the at least one light guide layer from the detection zone towards the detector, the coupling out zone being a part of the at least one 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 at least one light guide layer into the detection zone; and

,

wherein the primary light of from the light emitter is being coupled into the primary light guide layer section via an the entry surface and running inside the interior of the at least one light guide layer from the entry surface to the detection zone, 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 being reflected into the secondary light guide layer section and the light guide layer provides a light guide section for the light path of the secondary light running inside the carrier film between at least one light guide layer in a direction opposite to the primary light from the detection zone and towards 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 analysis system according to claim 1 wherein a side of in which the at least one light guide layer includes a side opposed to the coupling out zone is adapted positioned and arranged, 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 analysis system according to claim 1 wherein the side of in which the at least one light guide layer which is includes a side opposed to the detection zone is adapted positioned and arranged, 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 secondary light guide section for the secondary light.

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

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

6. The test element analysis system according to claim 5 wherein the first primary light guide layer and the second secondary light guide layer are separated, at least on a part of their length, by an optical barrier.

7. The test element analysis system according to claim 6 wherein the optical barrier comprises three partial layers, a first partial layer being adjacent to the primary light guide layer and having a refraction index which is lower than the refraction index of the primary light guide layer, a second partial layer being adjacent to the secondary light guide layer and having a refraction index which is lower than the refraction index of the secondary light guide layer, 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 at least one light guide layer, the carrier film having an elongated, strip-shaped form and the at least one light guide layer extending along the a longitudinal dimension of the carrier film; and

a test field secured to the at least one 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 comprising a detection zone and a reagent system, the reagent system including a reagent which upon reaction of which the reagent system with components at least one component of the liquid sample causes an optically measurable change in a the 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 the test field having components causing strong optical scattering and diffusely reflecting primary light directed thereon, the detection zone of the test field having a scattering coefficient and an absorption coefficient, and the scattering coefficient being at least ten times greater than the absorption coefficient;

wherein the carrier film comprises comprising a coupling out zone which is a part of the at least one 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 at least one light guide layer into the detection zone; and

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

,

wherein secondary light which is diffusely reflected from the detection zone is being reflected into the at least one light guide layer, and the at least one light guide layer provides providing a secondary light guide section for the light path of directing the secondary light running inside the at least one light guide layer in a direction opposite to the primary light 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 in which the at least one light guide layer includes a side opposed to the coupling out zone is adapted positioned and arranged, 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 in which the at least one light guide layer which is includes a side opposed to the detection zone is adapted positioned and arranged, 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 secondary 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 at least one flat side of the carrier film to which the test field is secured in such a manner that the liquid sample components wet the at least one light guide layer in the coupling out zone.

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

13. The test element according to claim 12 wherein the first primary light guide layer and the second secondary 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 layer and having a refraction index which is lower than the refraction index of the primary light guide layer, a second partial layer being adjacent to the secondary light guide layer and having a refraction index which is lower than the refraction index of the secondary light guide layer, 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 at least one light guide layer, the carrier film having an elongated, strip-shaped form and the at least one light guide layer extending along the a 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 comprising a detection zone and a reagent system, the detection zone being located on a side of the test field directed towards the carrier film, the reagent system including a reagent which upon reaction of which the reagent system with components at least one component of the sample causes an optically measurable change in a the detection zone which is a part of the test field, the optically measurable change being characteristic for the analysis, the test field having components causing strong optical scattering and diffusely reflecting primary light directed at the test field, the detection zone of the test field having a scattering coefficient and an absorption coefficient, and the scattering coefficient being at least ten times greater than the absorption coefficient; and

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

,

wherein the at least one light guide layer or a second light guide layer is including a secondary light guide section configured to pass secondary light in a direction opposite to the primary 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 in which the at least one light guide layer includes a side opposed to the coupling out zone is adapted positioned and arranged, 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 in which the at least one light guide layer which is includes a side opposed to the detection zone is adapted positioned and arranged, 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 secondary 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 at least one flat side of the carrier film to which the test field is secured in such a manner that the liquid sample components wet the at least one light guide layer in the coupling out zone.

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

20. The test element according to claim 19 wherein the first primary light guide layer and the second secondary 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 layer and having a refraction index which is lower than the refraction index of the primary light guide layer, a second partial layer being adjacent to the secondary light guide layer and having a refraction index which is lower than the refraction index of the secondary light guide layer, 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 at least one light guide layer, the carrier film having an elongated, strip-shaped form and the at least one light guide layer extending along the a longitudinal dimension of the carrier film;

and the test element further including a test field secured to the at least one 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 comprising a detection zone and a reagent system, the reagent system including a reagent which upon reaction of which the reagent system with components at least one component of the liquid sample causes an optically measurable change in a the 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 being diffusely reflected therefrom;

wherein the carrier film comprises comprising a coupling out zone which is a part of the at least one 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 at least one light guide layer into the detection zone;

wherein the test field contains test field components causing strong optical scattering and diffusely reflecting therefrom primary light directed thereon;

and wherein the detection zone of the test field having a scattering coefficient and an absorption coefficient and the scattering coefficient of the detection zone is being 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 at least one light guide layer, wherein the primary light emitted from the light emitter is being coupled into the at least one light guide layer through an entry surface;

and wherein the coupled in primary light is being guided inside the at least one 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 to a detector;

wherein, the secondary light generated by diffuse reflection in the detection zone is being transported inside the at least one light guide layer towards the detector and the secondary light is being coupled out from the at least one light guide layer in a direction opposite to the primary light towards the detector.

23. The test element method according to claim 22 wherein a side of in which the at least one light guide layer includes a side opposed to the coupling out zone is adapted positioned and arranged, 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 method according to claim 22 wherein the side of in which the at least one light guide layer which is includes a side opposed to the detection zone is adapted positioned and arranged, 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 at least one light guide section for the secondary light layer.

25. The test element method according to claim 22 wherein the test field is sufficiently absorbent to transport liquid sample components in the coupling out zone to the at least one flat side of the carrier film to which the test field is secured in such a manner that the liquid sample components wet the at least one light guide layer in the coupling out zone.

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

27. The test element method according to claim 26 wherein the first primary light guide layer and the second secondary light guide layer are separated, at least on a part of their length, by an optical barrier.

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