On-board control for analytical elements

• US 20050123441A1
• Filed: 10/12/2004
• Published: 06/09/2005
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Kotzan, Holger, Dreibholz, Joerg, Nortmeyer, Christine, Lungu, Mihail-Onoriu, Unkrig, Volker, Hoenes, Joachim, Horn, Carina, Marquant, Michael
• Granted Patent: US 7,914,752 B2
• Time in Patent Office: Days
• US Class Current: 422/56
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/17 Nitrogen containing
• CPC Class Codes: Y10T 436/170769 N-Nitroso containing [e.g., nitrosamine, etc.]
• CPC Class Codes: Y10T 436/179228 Both nitrogen oxide and dioxide

Abstract

The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Claims

1. A reagent system for the on-board control of analytical elements comprising an organic N-oxide or a nitroso compound.

2. The reagent system of claim 1, wherein said reagent system undergoes a change when stressed that can be detected optically or electrochemically.

3. The reagent system of claim 1, wherein said reagent system comprises a reducing agent.

4. The reagent system of claim 3, wherein the reducing agent is selected from sugars, polyalcohols, glycine, and cysteine-containing proteins.

5. The reagent system of claim 4, wherein the reducing agent is glycine or glucose.

6. The reagent system of claim 1, wherein the N-oxide is resazurin.

7. The reagent system of claim 1, wherein the nitroso compound is a substituted p-nitrosoaniline.

9. An analytical element comprising a reagent system for a detection reaction and the reagent system for the on-board control of analytical elements of claim 1.

10. The analytical element of claim 9, wherein the on-board control is integrated into the reagent system for the detection reaction.

11. The analytical element of claim 9, wherein the reagent system for the detection reaction comprises reagents for determining coagulation parameters.

12. A method for the control of analytical elements as claimed in claim 9, comprising examining the reagent system for the on-board control optically or electrochemically with the aid of a measuring instrument for changes which can indicate a stress of the analytical element.

13. The method of claim 12, wherein the analytical elements for which a stress has been detected are not released by the measuring instrument for measurement of a sample liquid with the aid of a reagent system for the detection reaction.

14. The method of claim 12, wherein the reagents for the control reaction as well as the reagents for the detection reaction are examined optically.

15. The method of claim 12, wherein the reagents for the control reaction and the reagents for the detection reaction are examined electrochemically.

16. The method of claim 12, wherein the reagents for the control reaction are examined optically and the reagents for the detection reaction are examined electrochemically.

17. The method of claim 12, wherein the reagents for the control reaction are examined electrochemically and the reagents for the detection reaction are examined optically.