Analytical aid

• US 9,726,612 B2
• Filed: 07/13/2015
• Issued: 08/08/2017
• Est. Priority Date: 04/12/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Scherer, Karl-Heinz, List, Hans
• Primary Examiner(s): White, Dennis M
• Application Number:
  US14/797,536
• Publication Number:
  US 20150316485A1
• Time in Patent Office: 757 Days
• CPC Class Codes: F23N 1/002 using electronic means F23N1/04 - F23N1/10 take precedence
• CPC Class Codes: F23N 2223/08 Microprocessor; Microcomputer
• CPC Class Codes: F23N 2231/02 using electric energy accumulators
• CPC Class Codes: F23N 2231/10 for component failures
• CPC Class Codes: F23N 2231/18 Detecting fluid leaks
• CPC Class Codes: F23N 2231/22 using warning lamps
• CPC Class Codes: F23N 5/242 using electronic means
• CPC Class Codes: G01N 21/78 producing a change of colour

Abstract

A process for producing an analytical aid for the detection of at least one analyte in a sample, such as a body fluid. The analytical aid includes at least one housing and at least one test element including at least one test chemistry. The process includes the following steps: providing the test element; and producing at least one housing part of the housing using at least one shaping process, during which the test element is connected to the housing part.

Claims

1. A process for producing an analytical aid for the detection of at least one analyte in a sample, wherein the analytical aid comprises at least one housing and at least one test element comprising at least one test chemistry, wherein the process comprises:

a. providing the at least one test element; and

b. producing at least one housing part of the housing by means of at least one shaping process, during which the test element is connected to the housing part;

wherein a plurality of analytical aids is produced, and wherein the process is carried out such that the plurality of analytical aids are contained in an analytical magazine.

2. The process of claim 1, wherein the shaping process comprises at least one casting process.

3. The process of claim 1, wherein the shaping process comprises at least one plastics shaping process, wherein the plastics shaping process is selected from in-mold coating and overmolding.

4. The process of claim 1, wherein, in process step b), at least part of the test element is inserted into a shaping mold and is at least partly contacted, in the shaping mold, with at least one housing material of the housing part, wherein the at least one test element part inserted into the shaping mold rests, via at least one section, on at least one wall of the shaping mold, wherein process step b) is carried out such that the wall of the shaping mold, at least in the region on which the section of the test element rests on the wall, has a temperature of not more than 130°

C. while process step b) is being carried out.

5. The process of claim 1, wherein, in process step b), at least part of the test element is inserted into a shaping mold and is at least partly contacted, in the shaping mold, with at least one housing material of the housing part, wherein the at least one test element part inserted into the shaping mold rests, via at least one section, on at least one wall of the shaping mold, wherein process step b) is carried out such that the wall of the shaping mold, at least in the region on which the section of the test element rests on the wall, has a temperature of not more than 120°

C. while process step b) is being carried out.

6. The process of claim 1, wherein, in process step b), at least part of the test element is inserted into a shaping mold and is at least partly contacted, in the shaping mold, with at least one housing material of the housing part, wherein the at least one test element part inserted into the shaping mold rests, via at least one section, on at least one wall of the shaping mold, wherein process step b) is carried out such that the wall of the shaping mold, at least in the region on which the section of the test element rests on the wall, has a temperature of not more than 110°

C. while process step b) is being carried out.

7. The process of claim 4, wherein the section of the test element which rests on the wall comprises at least part of the test chemistry.

8. The process of claim 4, wherein the section of the test element which rests on the wall comprises at least part of a test field area of the test chemistry.

9. The process of claim 1, wherein, in process step b), the test element is connected to the housing part such that at least one surface of the test chemistry as test field area for input of the sample remains uncovered by a housing material of the housing part, wherein the housing is configured such that at least one observation window is produced in the housing, wherein the test field area is optically monitorable through the observation window of the housing.

10. The process of claim 9, wherein the process is carried out such that the housing forms at least one chamber, wherein the test field area faces an interior space of the at least one chamber.

11. The process of claim 1, wherein the test chemistry is selected in terms of stability such that it is stable, at least for a short time, with respect to temperatures of 100°

C.

12. The process of claim 1, wherein the test chemistry is selected in terms of stability such that it is stable, at least for a short time, with respect to temperatures of 110°

C.

13. The process of claim 1, wherein the test chemistry is selected in terms of stability such that it is stable, at least for a short time, with respect to temperatures of 120°

C.

14. The process of claim 1, wherein the test element comprises at least one support element, wherein the test chemistry is connected to the support element.

15. The process of claim 14, wherein the test chemistry is connected to the support element by applying at least one layer of the test chemistry to the support element.

16. The process of claim 14, wherein the support element is a disc-shaped support element, wherein the test chemistry is applied to the support element as a coating, wherein the coating provides test field areas for the analytical aids.

17. The process of claim 16, wherein a disc-shaped support element is a circular-disc-shaped support element.

18. The process of claim 16, wherein the disc-shaped support element is a circular-ring-shaped support element.

19. The process of claim 1, wherein the analytical aids are accommodated in a common magazine housing, wherein the process is carried out such that the housings of the analytical aids are constituents of the magazine housing.

20. An analytical aid for the detection of at least one analyte in a sample, wherein the analytical aid comprises at least one housing and at least one test element comprising at least one test chemistry, wherein the analytical aid is produced by the process comprising:

a. providing the at least one test element; and

b. producing at least one housing part of the housing by means of at least one shaping process, during which the test element is connected to the housing part;

wherein a plurality of analytical aids is produced, and wherein the process is carried out such that the plurality of analytical aids are contained in an analytical magazine.