Sterilizable chemistry for test elements

Patent metadata

Field	Value
Publication number	US-9399792-B2
Application number	US-201213493251-A
Country	US
Kind code	B2
Filing date	Jun 11, 2012
Priority date	Dec 11, 2009
Publication date	Jul 26, 2016
Grant date	Jul 26, 2016

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.

First claim

What is claimed is:

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:

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.

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)

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, CI, 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 .

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:

Assignees

• Horn Carina
• Steinke Nelli
• Roche Diabetes Care Inc

Inventors

• Horn Carina
• Steinke Nelli

Classifications

• G01N2333/904

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

• C12Q1/54 Primary

  involving glucose or galactose · CPC title

• A61L2202/11

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

• C12Y101/01047

  Glucose 1-dehydrogenase (1.1.1.47) · CPC title

• A61L2/081

  Gamma radiation · CPC title