Methods of producing sterilized diagnostic test elements

Patent metadata

Field	Value
Publication number	US-10106835-B2
Application number	US-201615218171-A
Country	US
Kind code	B2
Filing date	Jul 25, 2016
Priority date	Dec 11, 2009
Publication date	Oct 23, 2018
Grant date	Oct 23, 2018

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.

First claim

The invention claimed is:

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:

in which:
A=adenine or an analog thereof,
T=in each case independently denotes O or S,
U=in each case independently denotes OH, SH, BH 3 − , or BCNH 2 − ,
V=in each case independently denotes OH or a phosphate group, or two groups that form a cyclic phosphate group,
W═COOR, CON(R) 2 , COR, or CSN(R) 2 in which R in each case independently denotes H or C 1 -C 2 -alkyl,
X 1 , X 2 =in each case independently denote O, CH 2 , CHCH 3 , C(CH 3 ) 2 , NH, or NCH 3 ,
Y═NH, S, O, or CH 2 ,
Z=a linear or cyclic organic residue, or
a salt or a reduced form thereof.

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)

in which a single bond or double bond is present between R5′ and R5″, and in which:
R4=in each case independently denotes H, F, Cl, or CH 3 ,
R5=O or C(R4) 2 ,
R5′=O, S, NH, NC 1 -C 2 -alkyl, C(R4) 2 , CHOH, or CHOCH 3 ,
R5″=C(R4) 2 , CHOH, or CHOCH 3 if a single bond is present between R5′ and R5″,
R5′=R5″=C(R4) 2 if a double bond is present between R5′ and R5″,
R6=in each case independently denotes CH or CCH 3 , and
R6′=in each case independently denotes CH or CCH 3 .

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:

Assignees

• Roche Diabetes Care Inc

Inventors

• Horn Carina
• Steinke Nelli

Classifications

• A61L2/087

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• C12Y101/01047

  Glucose 1-dehydrogenase (1.1.1.47) · CPC title

• A61L2/28

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title

• G01N2333/904

  acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1) · CPC title

• A61L2202/11

  Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps · CPC title