Sterilizable chemistry for test elements

• US 9,399,792 B2
• Filed: 06/11/2012
• Issued: 07/26/2016
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Horn, Carina, Steinke, Nelli
• Primary Examiner(s): Desai, Anand
• Application Number:
  US13/493,251
• Publication Number:
  US 20130011871A1
• Time in Patent Office: 1,506 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/11 Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Y 101/01047 Glucose 1-dehydrogenase (1.1.1.47)
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)

Abstract

In one non-limiting aspect, sterilizable reagent materials for diagnostic elements are provided. In other aspects, sterilized diagnostic elements and techniques for the production of the same are disclosed. In one embodiment, a sterilized diagnostic element includes a chemical detection reagent including at least one component that is sensitive to ionizing radiation. The sterilized diagnostic element is also mediator-free and the at least one component sensitive to ionizing radiation is present in a functional form in a proportion of ≧80% based on the total amount of the respective component in the diagnostic element before sterilization. In certain aspects, the at least one component sensitive to ionizing radiation includes one or both of an enzyme and a coenzyme. Other aspects include, but are not limited to, unique methods, techniques, products, systems and devices involving sterilizable reagent materials or sterilized diagnostic elements.

Claims

1. A sterilized diagnostic element, comprising:

a chemical detection reagent including at least one component sensitive to ionizing radiation, wherein the sterilized diagnostic element is mediator-free, the at least one component sensitive to ionizing radiation is present in a functional form in a proportion of ≧

80% based on the total amount of the respective component in the diagnostic element before sterilization, and the at least one component sensitive to ionizing radiation includes both an enzyme and a coenzyme, wherein the enzyme is one of a nicotinamide adenine dinucleotide (NAD/NADH)-dependent dehydrogenase or a nicotinamide adenine dinucleotide phosphate (NADP/NADPH)-dependent dehydrogenase, and wherein the coenzyme is a NAD(P)/NAD(P)H compound.

2. The sterilized diagnostic element of claim 1, wherein the at least one component sensitive to ionizing radiation is present in a functional form in a proportion of ≧

90% based on the total amount of the respective component in the diagnostic element before sterilization.

3. The sterilized diagnostic element of claim 1, wherein the enzyme is one of a glucose dehydrogenase (EC 1.1.1.47) and a glucose-6-phosphate dehydrogenase (EC 1.1.1.49).

4. The sterilized diagnostic element of claim 1, wherein the NAD(P)/NAD(P)H compound is a stabilized NAD(P)/NAD(P)H compound.

5. The sterilized diagnostic element of claim 1, further comprising one of an integrated and a separate sample collection element.

6. The sterilized diagnostic element of claim 5, wherein the sample collection element is a needle element.

7. The sterilized diagnostic element of claim 1, further comprising sterile packaging.

8. The sterilized diagnostic element of claim 1, further comprising a configuration structured to generate an optically or electrochemically detectable signal.

9. The sterilized diagnostic element of claim 1, further comprising a test element configuration including one of an integrated needle element, a test tape arrangement and a test strip arrangement.

10. A storage container, comprising the diagnostic element of claim 1 and a sample collection element.

11. The storage container of claim 10, further comprising a magazine configuration.

12. The sterilized diagnostic element of claim 4, wherein the stabilized NAD(P)/NAD(P)H compound is a compound according to formula (I), and wherein the compound according to formula (I) is as follows:

13. The sterilized diagnostic element of claim 12, wherein Z is a saturated or unsaturated carbocyclic or heterocyclic five-membered ring according to formula (II), wherein formula (II) is as follows:

Z=a carbocyclic 5-membered rim of the general formula (II)

14. The sterilized diagnostic test element of claim 4, wherein

R4=H,

R5′

=CHOH,

R5″

=CHOH,

R5=C(R4)₂,

R6=CH, and

R6′

=CH.

15. The sterilized diagnostic element of claim 4, wherein the stabilized NAD(P)/NAD(P)H compound is a compound according to formula (III), and wherein formula (III) is as follows: