On-board control for analytical elements

• US 7,914,752 B2
• Filed: 10/12/2004
• Issued: 03/29/2011
• 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
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Gerido; Dwan A
• Application Number:
  US10/962,796
• Publication Number:
  US 20050123441A1
• Time in Patent Office: 2,359 Days
• Field of Search: 435/4, 435/7.1, 435/7.93, 435/7.94, 435/7.95, 435/13, 422/16, 422/55, 422/73, 422/5, 422/565, 422/420, 422/400, 436/520, 436/14, 436/16, 436/74, 436/95, 436/107, 436/118, 436/125
• US Class Current: 422/400
• 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 a detection reaction, and

an on-board control comprising a second reagent system for determining 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 the results obtained therefrom, the second reagent system comprising a reagent comprising an organic N-oxide or a nitroso compound and a reducing agent selected from sugars, polyalcohols, glycine, and cysteine-containing proteins.

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

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

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

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

6. The analytical element of claim 1, wherein the second reagent system for on-board control is integrated into the first reagent system for the detection reaction.

7. The analytical element of claim 1, wherein the reagent system for the detection reaction comprises reagents for determining coagulation parameters.

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