Test element analysis system

• US 8,119,069 B2
• Filed: 10/07/2010
• Issued: 02/21/2012
• 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:
  US12/899,921
• Publication Number:
  US 20110033341A1
• Time in Patent Office: 502 Days
• Field of Search: 422/82.05, 422/82.11
• 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, comprising a test element including a carrier film having at least one flat side and a test field secured to the flat side and an evaluation instrument including a test element holder for positioning a test element in a measuring position, a measuring device for measuring the optically measurable change in the detection zone, and a housing within the measuring device is positioned. The test element is positioned in the measuring position in such a manner that a first partial section of the test element is located inside the housing and a second partial section is located outside of the housing to be easily accessible.

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, the test field containing a reagent system comprising a soluble reagent and a detection zone located on a side of the test field directed towards the carrier film, a reaction of the reagent system with at least one component of the sample causing an optically measurable change in the detection zone, said optically measurable change being characteristic for the analysis; and

an evaluation instrument including a test element holder for positioning the test element in a measuring position, a measuring device for measuring the optically measurable change in the detection zone, and a housing containing the measuring device, 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;

the carrier film comprising at least one light guide layer and a coupling out zone, the carrier film having an elongated, strip-shaped form and a longitudinal dimension, 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;

the primary light of the light emitter being 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 along the longitudinal dimension of the carrier film;

secondary light which is diffusely reflected from the detection zone being reflected into the light guide layer and the light guide layer providing a light guide section for the light path of the secondary light running inside the carrier film along the longitudinal dimension of the carrier film between the detection zone and the detector;

the test element being positioned in the measuring position in such a manner that a first partial section of the test element is located inside the housing and a second partial section is located outside of the housing to be easily accessible;

and the entry surface being located in the first partial section, and the test field being located in the second partial section.

2. The test element analysis system according to claim 1 wherein the liquid sample comprises a body liquid of human beings or of animals.

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

4. The test element analysis system according to claim 1 wherein the 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.

5. The test element analysis system 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 the secondary light diffusely reflected from the detection zone, to coincide with the direction of the light guide layer leading towards the detector.

6. 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 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.

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

8. The test element analysis system according to claim 1 wherein the test field contains components causing strong optical diffusion.

9. The test element analysis system 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 primary light guide, and the secondary light from the detection zone is coupled into a second light guide layer serving as secondary light guide.

10. The test element analysis system according to claim 9 wherein the test field is fixed to the flat side of the primary light guide and the test field and the secondary light guide are located on opposed sides of the primary light guide.

11. The test element analysis system according to claim 9 wherein the light guide layers are separated, at least on a part of their length, by an optical barrier.