Analytical element and method for the determination of an analyte in a liquid

• US 6,506,575 B1
• Filed: 09/22/2000
• Issued: 01/14/2003
• Est. Priority Date: 09/24/1999
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Knappe, Wolfgang Reinhold, Pachl, Rudolf, Gaa, Otto
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/667,931
• Time in Patent Office: 844 Days
• Field of Search: 435/25, 435/14, 435/19, 435/283.1, 435/286.5, 435/28
• US Class Current: 435/25
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

The invention concerns an analytical element for determining the amount of an analyte in a liquid containing a sample application zone (1) and a detection zone (2) which are in liquid-transferring contact, the latter containing at least one enzyme and an indicator substance, the enzyme catalysing a reaction in which the analyte or a substance derived from the analyte participates and the indicator substance forming a signal when the analyte is present which signal correlates with the amount of analyte, and containing a liquid-permeable interference-reducing layer (3) in direct contact with the detection zone (2) arranged such that liquid does not reach the detection zone until it has passed through the interference-reducing layer, the interference-reducing layer containing at least one enzyme which participates in a reaction of the analyte to be determined or of a substance derived from the analyte, wherein the analyte or the substance derived from the analyte is converted enzymatically in the interference-reducing layer into end products which cannot contribute to the signal formation by the indicator substance, and a method for the determination of an analyte in a liquid by means of such an analytical element.

Claims

1. Analytical element for determining the amount of an analyte in a liquid, the element comprising a sample application zone and a detection zone which are in liquid-transferring contact, the detection zone containing at least one enzyme and an indicator substance, the enzyme catalysing a reaction in which the analyte or a substance derived from the analyte participates and the indicator substance forming a signal when the analyte is present which signal correlates with the amount of analyte, and a liquid-permeable interference-reducing layer in direct contact with the detection zone arranged such that liquid does not reach the detection zone until the liquid has passed through the interference-reducing layer, the interference-reducing layer containing at least one enzyme which participates in a reaction of the analyte to be determined or of a substance derived from the analyte, wherein the analyte or the substance derived from the analyte is converted enzymatically in the interference-reducing layer into end products which cannot contribute to the signal formation by the indicator substance.

2. Analytical element as claimed in claim 1, wherein the interference-reducing layer and detection zone are arranged above one another.

5. Analytical element as claimed in claim 1, wherein a layer is located in the sample application zone that retains particles contained in the liquid.

6. Analytical element as claimed in claim 2, wherein a layer is located in the sample application zone that retains particles contained in the liquid.

11. Analytical element as claimed in claim 1, wherein the end product formed in the interference-reducing layer is colorless.

12. Analytical element as claimed in claim 2, wherein the end product formed in the interference-reducing layer is colorless.

14. Analytical element as claimed in claim 5, wherein the end product formed in the interference-reducing layer is colorless.

16. Analytical element as claimed in claim 1, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

17. Analytical element as claimed in claim 2, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

19. Analytical element as claimed in claim 5, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

21. Analytical element as claimed in claim 11, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

25. Analytical element as claimed in claim 1, wherein the signal generated by the indicator substance in the presence of the analyte is a color change.

26. Analytical element as claimed in claim 25, wherein the interference-reducing layer and detection zone are arranged above one another.

27. Analytical element as claimed in claim 25, wherein the interference-reducing layer and the layer of the detection zone containing enzyme and indicator substance are arranged in direct contact with one another.

28. Analytical element as claimed in claim 25, wherein the interference-reducing layer is in the sample application zone.

29. Analytical element as claimed in claim 25, wherein the end product formed in the interference-reducing layer is colorless.

30. Analytical element as claimed in claim 25, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

31. Analytical element as claimed in claim 25, wherein a layer is located in the sample application zone that retains particles contained in the liquid.

3. Analytical element as claimed in 2, wherein the interference-reducing layer and the layer of the detection zone containing enzyme and indicator substance are arranged in direct contact with one another.

4. Analytical element as claimed in 1, wherein the interference-reducing layer and the layer of the detection zone containing enzyme and indicator substance are arranged in direct contact with one another.

7. Analytical element as claimed in claim 4, wherein a layer is located in the sample application zone that retains particles contained in the liquid.

13. Analytical element as claimed in claim 4, wherein the end product formed in the interference-reducing layer is colorless.

18. Analytical element as claimed in claim 4, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

8. Analytical element as claimed in 1, wherein the interference-reducing layer is in the sample application zone.

15. Analytical element as claimed in claim 8, wherein the end product formed in the interference-reducing layer is colorless.

20. Analytical element as claimed in claim 8, wherein the layer of the detection zone containing enzyme contains the necessary coenzyme if the enzyme of the detection layer is coenzyme-dependent.

9. Analytical element as claimed in 2, wherein the interference-reducing layer is in the sample application zone.

10. Analytical element as claimed in 4, wherein the interference-reducing layer is in the sample application zone.

22. A method for the determination of an analyte in a liquid, the method comprising the steps of:

providing a multilayer analytical element comprising a sample application zone, a detection zone in liquid-transferring contact with the sample application zone, the detection zone containing at least one enzyme and an indicator substance, and a liquid-permeable interference-reducing layer in direct contact with the detection zone arranged such that liquid does not reach the detection zone until the liquid has passed through the interference-reducing layer, the interference-reducing layer containing at least one enzyme which participates in a reaction of the analyte to be determined or of a substance derived from the analyte,

applying the liquid to the sample application zone in an undosed manner so that the liquid passes through the interference-reducing layer into the detection zone and fills the detection zone where the enzyme catalyzes a reaction in which the analyte or a substance derived from the analyte participates and forms a signal when the analyte is present which signal correlates with the amount of analyte present in the liquid and excess liquid remains in the interference-reducing layer is exposed to the at least one enzyme which enzymatically converts the analyte or the substance derived from the analyte into end products which cannot contribute to the signal formation by the indicator substance, and

determining the amount of analyte in the liquid.

23. The method of claim 22 wherein the applying step includes filling the detection zone with liquid so that excess liquid remains in the application zone.

24. Method as claimed in claim 22, wherein the liquid to be examined at least partially passes through the interference-reducing layer before the enzyme of the interference-reducing layer begins to act.