Method for producing an analytical consumable

• US 8,409,382 B2
• Filed: 08/31/2011
• Issued: 04/02/2013
• Est. Priority Date: 03/13/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schwoebel, Wolfgang, Dreibholz, Joerg
• Primary Examiner(s): Lee, Katarzyna Wyrozebski
• Assistant Examiner(s): Rivera, Joshel
• Application Number:
  US13/222,205
• Publication Number:
  US 20120055606A1
• Time in Patent Office: 580 Days
• Field of Search: 156/64, 156/350, 156/378, 156/379, 204/403.01, 204/403.02
• US Class Current: 156/64
• CPC Class Codes: B05C 11/00 Component parts, details or accessories not specifically provided for in groups B05C1/00 - B05C9/00 means for manipulating or holding work B05C13/00; enclosures for apparatus, booths B05C15/00; spray booths B05B16/00
• CPC Class Codes: B32B 38/0008 Electrical discharge treatment, e.g. corona, plasma treatment; wave energy or particle radiation heat treatment B32B38/0036
• CPC Class Codes: G01N 2035/00168 Manufacturing or preparing test elements
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A method for producing an analytical consumable is proposed. The analytical consumable comprises at least one carrier and at least one analytical aid connected to the carrier. At least one optically sensitive material is applied to the carrier, said material being designed to carry out at least one optically detectable alteration in the event of action of an electromagnetic radiation. In at least one coding step, at least one function information item about the analytical consumable is introduced into the optically sensitive material by means of electromagnetic radiation. The function information item is designed to enable at least one analytical instrument to use the analytical consumable correctly.

Claims

1. A method for producing an analytical consumable, the analytical consumable comprising at least one carrier with at least one analytical aid connected to the carrier, wherein the analytical aid comprises one of an analytical aid that is sensitive to an analyte and an analytical aid that comprises a device for generating or providing a liquid sample, wherein the at least one carrier further includes at least one coding field including an optically sensitive material applied to the carrier, wherein, in at least one coding step, at least one function information item about the analytical consumable is introduced into the optically sensitive material of the coding field by an electromagnetic radiation that causes an optically detectable alteration of the optically sensitive material, wherein the function information item is designed to enable at least one analytical instrument to use the analytical consumable correctly.

2. The method according to claim 1, wherein the electromagnetic radiation comprises a laser radiation.

3. The method according to claim 1, wherein at least one of at least one one-dimensional, at least one two-dimensional, and at least one three-dimensional bar code are introduced into the optically sensitive material in the coding step.

4. The method according to claim 1, wherein the optically sensitive material is applied to the carrier to form the at least one coding field.

5. The method according to claim 4, wherein the coding field is in the form of a polygonal coding field.

6. The method according to claim 4, wherein the coding field is in the form of a round coding field.

7. The method according to claim 4, wherein the coding field is applied by a printing method in which the optically sensitive material or a precursor of the optically sensitive material is printed onto the carrier.

8. The method according to claim 4, wherein the analytical consumable comprises a plurality of analytical aids, wherein each analytical aid is assigned at least one coding field.

9. The method according to claim 4, wherein coding fields are arranged at a plurality of predetermined and known positions on the analytical consumable, wherein the coding fields are designed to be used wholly or in part as position markings.

10. The method according to claim 1, wherein the optically detectable alteration comprises an alteration of at least a reflection property of the optically sensitive material.

11. The method according to claim 1, wherein the optically sensitive material comprises a dye dissolved or dispersed in a matrix material.

12. The method according to claim 1, wherein the optically sensitive material comprises a pigment.

13. The method according to claim 12, wherein the pigment comprises a laser activatable pigment.

14. The method according to claim 1, wherein the function information item about the analytical consumable comprises at least one consumable-specific or aid-specific information item.

15. The method according to claim 14, wherein the function information item comprises at least one selected from the group consisting of:

a manufacturer;

a production method;

a detection reagent contained;

an analyte to be detected;

an analysis method to be used;

an analysis system to be used;

conditions under which an analysis is carried out;

parameters for an evaluation of measurements;

algorithms for an evaluation of measurements;

at least one correction factor for evaluation of measurements;

at least one function curve for evaluation of measurements;

batch numbers;

at least one individual identification;

batch-specific special features;

a number of analytical aids;

a device for generating or providing a liquid sample;

a lancet for generating or providing a liquid sample;

an endurance information item including at least one of an endurance date or an endurance restriction; and

a use restriction.

16. The method according to claim 1, wherein the analytical consumable comprises an analytical tape having a carrier tape and a plurality of analytical aids arranged on the carrier tape.

17. The method according to claim 1, wherein the analytical consumable comprises a test strip having at least one analytical aid.

18. The method according to claim 1, wherein the analytical aid comprises a test field for detecting at least one analyte in a sample.

19. The method of claim 18, wherein the analyte is a metabolite in a body fluid.

20. The method according to claim 1, wherein the analytical aid comprises a device for generating or providing a liquid sample.

21. The method according to claim 20, wherein the device is a lancet.

22. The method according to claim 1, wherein the analytical consumable has at least one housing, wherein the analytical aid is received at least partly in the housing, wherein the housing has at least one transparent region which is at least partly transparent to the electromagnetic radiation for an optical detection of the optically detectable alteration at a wavelength of the electromagnetic radiation used for the optical detection of the optically detectable alteration.

23. The method according to claim 1, furthermore comprising at least one calibration step, wherein in the calibration step at least one property of at least one analytical aid which the analytical consumable comprises is measured, wherein said property is converted at least partly into the function information item or a part of the function information item, wherein the coding step is subsequently carried out.

24. The method according to claim 4, wherein the coding field is applied by a laminating method in which a film of the optically sensitive material is laminated or adhesively bonded onto the carrier.

25. The method according to claim 1, wherein the optically detectable alteration comprises an alteration of at least a colour property of the optically sensitive material.

26. The method according to claim 1, wherein the optically detectable alteration comprises an alteration of at least an absorption property of the optically sensitive material.

27. The method according to claim 1, wherein the optically detectable alteration comprises an alteration of at least a refractive index of the optically sensitive material.

28. The method according to claim 1, wherein the optically sensitive material comprises a plastic which alters a refractive index in the event of action of the electromagnetic radiation.

29. The method according to claim 1, wherein the analytical consumable comprises a test disc having a plurality of analytical aids arranged on a surface or an edge of the test disc.

30. The method according to claim 1, wherein the analytical consumable comprises a foldable consumable having a plurality of analytical aids.