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 at least one shaping process, during which the test element is connected to the housing part.
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 the following steps:
a) providing the test element comprising the test chemistry; and
b) producing at least one housing part of the housing by means of at least one shaping process, during which the test element comprising the test chemistry is connected to the housing part,
wherein, in 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 application 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, 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 chamber.
2. The process according to claim 1 , wherein the shaping process comprises at least one casting process.
3. The process according to claim 1 , wherein the shaping process comprises at least one plastics shaping process, wherein the plastics shaping process is selected from a back injection molding and an insert molding.
4. The process according to claim 1 , wherein, in 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 part of the test element inserted into the shaping mold rests, via at least one section, on at least one wall of the shaping mold, wherein 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 step b) is being carried out.
5. The process according to claim 4 , wherein the section of the test element which rests on the wall comprises at least part of the test chemistry.
6. The process according to claim 5 , wherein the section of the test element which rests on the wall comprises a test field area of the test chemistry.
7. The process according to claim 4 , wherein 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 step b) is being carried out.
8. The process according to claim 4 , wherein 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 step b) is being carried out.
9. The process according to 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.
10. The process according to claim 9 , 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.
11. The process according to claim 9 , 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.
12. The process according to claim 1 , wherein the test element comprises at least one support element, wherein the test chemistry is connected to the support element.
13. The process according to claim 12 , wherein the support element is a disc-shaped support element, wherein the test chemistry is applied to the support element as a coating, and wherein the coating provides test field areas for the analytical aids.
14. The process according to claim 13 , wherein the support element is a circular-disc-shaped support element.
15. The process according to claim 13 , wherein the support element is a circular-ring-shaped support element.
16. The process according to claim 12 , wherein the test chemistry is connected to the support element by applying at least one layer of the test chemistry to the support element.
17. The process according to claim 1 , wherein a plurality of analytical aids is produced, wherein the process is carried out such that the analytical aids are contained in an analytical magazine.
18. The process according to claim 17 , 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.
19. The process according to claim 1 , wherein the sample is a body fluid.
20. An analytical aid for the detection of at least one analyte in a sample, obtainable by a process according to claim 1 , wherein the analytical aid comprises at least one housing comprising at least one housing part and at least one test element comprising at least one test chemistry, wherein the test element is connected to the housing part by means of a shaping process of the housing part, wherein, during the production of the housing part, the test element comprising the test chemistry is connected to the housing part such that at least one surface of the test chemistry as test field area for application 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, wherein the housing forms at least one chamber, and wherein the test field area faces an interior space of the chamber.
21. The analytical aid according to claim 20 , wherein the analytical aid comprises at least one lancet element for generating the sample.
22. The analytical aid according to claim 21 , wherein the at least one lancet element is at least one microsampler.
23. The analytical aid according to claim 20 , wherein the housing comprises at least one observation window accessible from an outer side of the housing, wherein at least one property change of the test element, is detectable from outside through the observation window.
24. The analytical aid according to claim 23 , wherein the observation window is configured such that at least one test field area of the test element is observable through at least one support element, which is at least partially optically transparent, of the test element.
25. The analytical aid according to claim 23 , wherein the at least one property change of the test element is selected from the group consisting of at least one color change and at least one change in at least one optical property.
26. An analytical magazine comprising a plurality of the analytical aids of claim 20 .