Method and reagent system with non-regenerable enzyme-coenzyme complex

• US 7,951,581 B2
• Filed: 01/10/2008
• Issued: 05/31/2011
• Est. Priority Date: 05/16/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Knappe, Wolfgang-Reinhold, Hoenes, Joachim, Horn, Carina
• Primary Examiner(s): Prouty; Rebecca E.
• Assistant Examiner(s): Martin; Paul C.
• Application Number:
  US12/008,283
• Publication Number:
  US 20080182324A1
• Time in Patent Office: 1,237 Days
• Field of Search: None
• US Class Current: 435/287.1
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: G01N 33/54353 with ligand attached to the carrier via a chemical coupling agent coatings G01N33/54393
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: Y02P 20/582 Recycling of unreacted starting or intermediate materials

Abstract

The present invention is generally directed towards a reagent system for detecting an analyte in a sample. The reagent system has a detection reagent comprising an enzyme-coenzyme complex in a form such that no regeneration of the coenzyme takes place, whereby the enzyme-coenzyme complex is employed in an at least stoichiometric amount relative to the analyte present in the sample, and a support to receive the detection reagent.

Claims

1. An apparatus for detecting an analyte in a sample, the analyte being present in the sample only up to a predetermined maximum possible concentration, the apparatus comprising:

(a) a support configured to receive a first volume of the sample; and

(b) a detection reagent provided on the support, the detection reagent comprising an enzyme-coenzyme complex, the detection reagent being provided in an amount such that the amount of enzyme-coenzyme complex is at least stoichiometric relative to the amount of analyte present in the sample;

wherein the enzyme-coenzyme complex is selected and configured to participate in a reaction with the analyte, and wherein the detection reagent does not include any mediator capable of reacting with the coenzyme.

2. The apparatus as claimed in claim 1, wherein the enzyme of the enzyme-coenzyme complex comprises an oxidoreductase and wherein the complex is further selected and configured such that the reaction of the complex with the analyte produces one or more reaction products including detectable amounts of an oxidized form or a reduced form of the coenzyme.

3. The apparatus as claimed in claim 2, wherein the complex is further selected and configured such that the amounts of the oxidized form or the reduced form of the coenzyme produced in the reaction products are detectable in about 5 seconds or less from the start of the reaction.

4. The apparatus as claimed in claim 2, wherein the amounts of the oxidized form or reduced form of the coenzyme are detectable by optical methods.

5. The apparatus as claimed in claim 1, wherein the coenzyme of the enzyme-coenzyme complex is selected from nicotine derivatives.

6. The apparatus as claimed in claim 1, wherein the enzyme-coenzyme complex is embedded in a gel matrix.

7. The apparatus as claimed in claim 6, wherein the gel matrix has a layer thickness of ≦

50 μ

m.

8. The apparatus as claimed in claim 1, wherein the support is at least partly optically transparent.

9. The apparatus as claimed in claim 1, wherein the support comprises an essentially planar structure.

10. The apparatus as claimed in claim 1, wherein the support comprises a plurality of different detection reagents.

11. The apparatus as claimed in claim 1, wherein the sample comprises a body fluid.

12. The apparatus as claimed in claim 11, wherein the body fluid comprises blood and the analyte comprises glucose.