On-Board Control for Analytical Elements

• US 20110177605A1
• Filed: 02/22/2011
• Published: 07/21/2011
• 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 8,137,980 B2
• Time in Patent Office: Days
• US Class Current: 436/106
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• 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. An analytical element comprising:

a first reagent system for detecting an analyte, and

an on-board control comprising a second reagent system that produces a signal independent of the presence of the analyte and comprises an organic N-oxide or a nitroso compound and a reducing agent.

2. The analytical element of claim 1, wherein said second reagent system determines whether at least one of the analytical element, the first reagent system and the second reagent system has been stressed under conditions that could damage the analytical element or affect results obtained therefrom.

3. The analytical element of claim 1, wherein the signal produced by the second reagent system can be detected optically or electrochemically.

4. The analytical element of claim 1, wherein the reducing agent is glycine or glucose.

5. The analytical element of claim 1, wherein the N-oxide is resazurin.

6. The analytical element of claim 1, wherein the nitroso compound is a substituted p-nitrosoaniline.

7. The analytical element of claim 1, wherein the second reagent system is integrated into the first reagent system.

8. The analytical element of claim 1, wherein the first reagent system comprises reagents for determining coagulation parameters.

9. The analytical element of claim 1, further comprising a heteropoly acid in combination with said nitroso compound.

10. A method for the control of analytical elements as claimed in claim 1, comprising detecting the signal from the second reagent system optically or electrochemically with the aid of a measuring instrument, wherein the signal indicates a stress of the analytical element.

11. The method of claim 10, wherein the analytical element for which a stress has been detected is not released by the measuring instrument for measurement of a sample liquid with the aid of the first reagent system.

12. The method of claim 10, wherein the signal produced by the second regent system and a signal produced by the first reagent system are detected optically.

13. The method of claim 10, wherein the signal produced by the second regent system and a signal produced by the first reagent system are detected electrochemically.

14. The method of claim 10, wherein the signal produced by the second regent system is detected optically and a signal produced by the first regent system is detected electrochemically.

15. The method of claim 10, wherein the signal produced by the second regent system is detected electrochemically and a signal produced by the first regent system is detected optically.