Analytical aid

• US 9,097,679 B2
• Filed: 10/11/2013
• Issued: 08/04/2015
• 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: List, Hans, Scherer, Karl-Heinz
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/052,269
• Publication Number:
  US 20140044608A1
• Time in Patent Office: 662 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: B05D 5/00 Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
• CPC Class Codes: B29C 48/08 flexible, e.g. films
• CPC Class Codes: G01N 15/0205 by optical means
• CPC Class Codes: G01N 2021/7793 Sensor comprising plural indicators
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00148 Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 21/01 Arrangements or apparatus for facilitating the optical investigation
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 : Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0256 : Sensor for insertion of sample, cuvette, test strip
• CPC Class Codes: G01N 27/3272 : Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/521 : Single-layer analytical elements
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/00069 : whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
• CPC Class Codes: Y10S 435/808 : Optical sensing apparatus
• CPC Class Codes: Y10S 435/97 : Test strip or test slide

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 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 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.