Methods of producing sterilized diagnostic test elements

• US 10,106,835 B2
• Filed: 07/25/2016
• Issued: 10/23/2018
• 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 U
• Application Number:
  US15/218,171
• Publication Number:
  US 20160333391A1
• Time in Patent Office: 820 Days
• Field of Search: None
• 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 elements and techniques for producing the same are disclosed. In one embodiment, a sterilized element includes a chemical detection reagent including at least one component that is sensitive to ionizing radiation. The sterilized 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 elements.

Claims

1. A method of producing a sterilized diagnostic element, the method comprising the steps of:

providing a mediator-free diagnostic test 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 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 (NAD P/NAD PhD-dependent dehydrogenase, and wherein the coenzyme is a NAD(PVNAD(P)H compound; and

,

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

2. The method of claim 1, wherein the mediator-free diagnostic element further comprises one of an integrated and a separate sample collection element.

3. The method of claim 2, wherein the sample collection element is a needle element.

4. The method of claim 1 further comprising the step of introducing the diagnostic element into a storage container before sterilizing.

5. The method of claim 4, wherein the storage container is a magazine.

6. The method of claim 4 further comprising the step of closing the storage container before sterilizing.

7. The method of claim 1, wherein the ionizing radiation includes electron radiation having a dose in a range of 15-35 kGy.

8. The method of claim 7, wherein the dose is in the range of 20-30 kGy.

9. The method of claim 1, wherein the ionizing radiation includes gamma radiation having a dose in a range of 15-35 kGy.

10. The method of claim 9, wherein the dose is in the range of 20-30 kGy.

11. The method 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).

12. The method of claim 1, wherein the NAD(P)/NAD(P)H compound is a stabilized NAD(P)/NAD(P)H compound.

13. The method of claim 12, 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:

14. The method of claim 13, 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 ring of the general formula (II)

15. The method of claim 14, wherein

R4=H,

R5′

=CHOH,

R5″

=CHOH,

R5=C(R4)₂,

R6=CH, and

R6′

=CH.

16. The method of claim 12, wherein the stabilized NAD(P)/NAD(P)H compound is a compound according to formula (Ill), and wherein formula (Ill) is as follows: