Analysis system for analyzing a sample on a test element

• US 20060024203A1
• Filed: 07/26/2005
• Published: 02/02/2006
• Est. Priority Date: 07/28/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schulat, Jochen, Jansen, Paul, Ringelspacher, Yvonne
• Granted Patent: US 8,318,106 B2
• Time in Patent Office: Days
• US Class Current: 422/82.50
• 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 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

The invention relates to an analysis system for analyzing a sample on a test element. The system has an analysis unit for generating a signal as a function of an analyte contained in a sample, and a detection unit for detecting the signal. The analysis system further includes a test element holder into which the test element can be reversibly introduced and in which it can be positioned relative to the analysis unit and the detection unit. The test element contains at least one guide element, which is suitable for laterally guiding the test element, so that the test element in the test element holder is held and guided only on an outer region of the test element, and an inner region of the test element introduced into the test element holder remains free. The test element contains a sample application site in the inner region.

Claims

1. Analysis system for analyzing a sample on a test element having an outer region and an inner region, the inner region containing a sample application site, the system comprising

an analysis unit for generating a signal as a function of an analyte contained in the sample, and

a detection unit for detecting the signal, characterized by a test element holder into which the test element can be reversibly introduced and in which the test element can be positioned relative to the analysis unit and the detection unit, the test element holder containing at least one guide element which is suitable for laterally guiding the test element, so that the test element in the test element holder is held and guided only on the outer region of the test element, and the inner region of the test element introduced into the test element holder remains free.

2. Analysis system of claim 1, wherein the guide element contains support faces, on which the test element rests via bearing faces in its outer region, and guide faces along which side faces of the test element are guided.

3. Analysis system of claim 2 wherein the guide faces are arranged obliquely with respect to the side faces of the test element.

4. Analysis system of claim 2 wherein the support faces have a width of from 0.1 mm to 1 mm.

5. Analysis system of claim 1 wherein the guide element contains two mutually opposite grooves, into which the test element can be inserted via its outer region.

6. Analysis system of claim 1 wherein the analysis unit and the detection unit are parts of measuring optics which are used to photometrically evaluate the test element.

7. Analysis system of claim 1 wherein the guide element is arranged above the analysis unit and/or the detection unit in the analysis system.

8. Analysis system of claim 1 wherein the guide element is arranged so that a test element introduced into the guide element is at a distance of at least 1 mm from the analysis unit and the detection unit in any position.

9. Analysis system of claim 1 wherein the test element holder has a stop, against which a test element abuts when it is being introduced into the guide element as soon as a defined position of the test element in the test element holder is reached.

10. Analysis system of claim 1 wherein the test element comprises a sample application site at one end in the inner region, the test element being tapered in the region of the sample application site.

11. Analysis system of claim 1 further comprising a storage container for a multiplicity of test elements, into which the test elements are transported back from the test element holder after use.

12. Analysis system of claim 11 further comprising a transport device formed to automatically extract a test element from the storage container, to automatically transport the test element into the test element holder and to automatically transport the test element back into the storage container after use.

13. Analysis system of claim 1 wherein the test element has a test field where the sample is analyzed, which is positioned in the inner region of the test element.

14. Analysis system of claim 13 wherein the test element contains a capillary for delivering the sample to the test field.

15. Analysis system of claim 1 wherein the test element holder is made of at least two parts, with the test element introduced into the test element holder resting in its outer region on a lower part of the test element holder and with a separate upper part of the test element holder resting on the test element in its outer region.

16. Analysis system of claim 15 wherein at least one pressure spring, which exerts a force on the upper part in the direction of the lower part of the test element holder, is arranged on the upper part of the test element holder.

17. Analysis system of claim 1 wherein the guide element has a ramp- or funnel-shaped introduction opening on the side where the test element is introduced into the test element holder.

18. Analysis system of claim 1 wherein the guide element is shaped so that it causes a defined deformation of the test element as it is being introduced into the test element holder, in order to fix it during use.

19. Method of analyzing the glucose content in a sample, the method comprising the steps of

providing a test element having an outer region and an inner region, the inner region containing a sample application site,

providing an analysis system comprising an analysis unit for generating a signal as a function of glucose contained in the sample, a detection unit for detecting the signal, and a test element holder into which the test element can be reversibly introduced and in which the test element can be positioned relative to the analysis unit and the detection unit, the test element holder containing at least one guide element which is suitable for laterally guiding the test element, so that the test element in the test element holder is held and guided only on the outer region of the test element, and the inner region of the test element introduced into the test element holder remains free,

applying a sample to the sample application site of test element,

introducing the test strip into the test element holder so that the test element is held on the outer region,

generating a signal as a function of the glucose contained in the sample, and

detecting the signal.

20. An apparatus for holding a test element used in an analysis system, the test element having an outer region and an inner region, the inner region containing a sample application site, the apparatus comprising:

a body being formed to include a guide element sized for laterally guiding the test element so that the test element in the body is held and guided only on the outer region of the test element, and the inner region of the test element introduced into the test element holder remains free, the guide element including spaced-apart support faces, on which the test element rests in its outer regions, and

an optical window spaced-apart from the guide element.

21. Apparatus of claim 20 wherein the guide element contains guide faces along which side faces of the test element are guided.

22. Apparatus of claim 21 wherein the guide faces are arranged obliquely with respect to the side faces of the test element.

23. Apparatus of claim 20 wherein the support faces have a width of from 0.1 mm to 1 mm.

24. Apparatus of claim 20 wherein the guide element contains two mutually opposite grooves, into which the test element can be inserted via its outer region.

25. Apparatus of claim 20 wherein the test element holder has a stop, against which a test element abuts when it is being introduced into the guide element as soon as a defined position of the test element in the test element holder is reached.

26. Apparatus of claim 20 wherein the test element holder is made of at least two parts, with the test element introduced into the test element holder resting in its outer region on a lower part of the test element holder and with a separate upper part of the test element holder resting on the test element in its outer region.

27. Apparatus of claim 26 wherein at least one pressure spring, which exerts a force on the upper part in the direction of the lower part of the test element holder, is arranged on the upper part of the test element holder.

28. Apparatus of claim 20 wherein the guide element has a ramp- or funnel-shaped introduction opening on the side where the test element is introduced into the test element holder.

29. Apparatus of claim 20 wherein the guide element is shaped so that it causes a defined deformation of the test element as it is being introduced into the test element holder, in order to fix it during use.