STERILIZABLE CHEMISTRY FOR TEST ELEMENTS

• US 20130011871A1
• Filed: 06/11/2012
• Published: 01/10/2013
• 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
• Granted Patent: US 9,399,792 B2
• Time in Patent Office: Days
• US Class Current: 435/26
• 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 one or both of an enzyme and a coenzyme.

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 at least one component includes the enzyme and the enzyme is one of a nicotinamide adenine dinucleotide (NAD/NADH)-dependent dehydrogenase and a nicotinamide adenine dinucleotide phosphate (NADP/NADPH)-dependent dehydrogenase.

4. The sterilized diagnostic element of claim 3, 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).

5. The sterilized diagnostic element of claim 3, wherein the at least one component further includes the coenzyme and the coenzyme is a NAD(P)/NAD(P)H compound.

6. The sterilized diagnostic element of claim 5, wherein the coenzyme is a stabilized NAD(P)/NAD(P)H compound.

7. The sterilized diagnostic element of claim 6, wherein the coenzyme is one of carbaNAD and carbaNADP.

8. The sterilized diagnostic element of claim 1, wherein the at least one component includes the coenzyme and the coenzyme is a NAD(P)/NAD(P)H compound.

9. The sterilized diagnostic element of claim 8, wherein the coenzyme is a stabilized NAD(P)/NAD(P)H compound.

10. The sterilized diagnostic element of claim 9, wherein the coenzyme is one of carbaNAD and carbaNADP.

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

12. The sterilized diagnostic element of claim 11, wherein the sample collection element is a needle element.

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

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

15. 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.

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

17. The storage container of claim 16, further comprising a magazine configuration.

18. A method for producing a sterilized diagnostic element, comprising:

providing a mediator-free diagnostic element comprising a chemical detection reagent including at least one component sensitive to ionizing radiation, wherein the at least one component sensitive to ionizing radiation includes one or both of an enzyme and a coenzyme; and

sterilizing the mediator-free diagnostic element with ionizing radiation, the ionizing radiation including one or both of electron radiation and gamma radiation.

19. The method of claim 18, wherein the mediator-free diagnostic element further comprises one of an integrated and a separate sample collection element.

20. The method of claim 19, wherein the sample collection element is a needle element.

21. The method of claim 18, which further includes introducing the diagnostic element into a storage container before sterilizing.

22. The method of claim 21, wherein the storage container is a magazine.

23. The method of claim 21, which further includes closing the storage container before sterilizing.

24. The method of claim 18, wherein the ionizing radiation includes electron radiation and the electron radiation has a dose in the range of 15-35 kGy.

25. The method of claim 24, wherein the dose is in the range of 20-30 kGy.

26. The method of claim 18, wherein the ionizing radiation includes gamma radiation and the gamma radiation has a dose in the range of 15-35 kGy.

27. The method of claim 26, wherein the dose is in the range of 20-30 kGy.