MARKING METHOD FOR THE REJECT MARKING OF TEST ELEMENTS

• US 20090090874A1
• Filed: 09/18/2008
• Published: 04/09/2009
• Est. Priority Date: 09/19/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schmidt, Gunter, Dick, Siegfried, Roper, Josef K., Stubenbord, Peter, Frank, Martin, Finke, Werner
• Granted Patent: US 8,618,511 B2
• Time in Patent Office: Days
• US Class Current: 250/484.4
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00168 Manufacturing or preparing test elements
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• 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: G21K 5/00 Irradiation devices discharge tubes for irradiating H01J37/00
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/53022 with means to test work or product

Abstract

The test elements are provided that are adapted to detect at least one analyte in a sample. At least some of the test elements are provided with a defect marking which contains information about defectiveness of the test elements. The test elements include at least one radiation-sensitive material. The test elements are exposed to at least one radiation, the radiation being adapted to induce marking in the form of at least one optically detectable change in the radiation-sensitive material.

Claims

1. A marking method for marking test elements, comprising:

providing test elements adapted to detect at least one analyte in a sample;

providing at least some of the test elements with a defect marking which contains information about defectiveness of the test elements, wherein the test elements include at least one radiation-sensitive material; and

exposing the test elements to at least one radiation, the radiation being adapted to induce marking in the form of at least one optically detectable change in the radiation-sensitive material.

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

3. The marking method according to claim 2, wherein the electromagnetic radiation is ultraviolet radiation.

4. The marking method according to claim 3, wherein the ultraviolet radiation includes a wavelength range between 250 nm and 400 nm.

5. The marking method according to claim 3, wherein the ultraviolet radiation includes a wavelength range from 350 nm to 380 nm.

6. The marking method according to claim 1, wherein at least one of the following light sources is used to generate the radiation:

an incandescent lamp;

a gas discharge lamp;

a laser;

a light-emitting diode; and

a flash lamp.

7. The marking method according to claim 1, wherein the optically detectable change comprises at least one other of the following changes:

a color change;

a change of luminescence, in particular fluorescence; and

a change of reflectivity.

8. The marking method according to claim 1, wherein the at least one radiation-sensitive material comprises at least one test material of the test elements, the at least one test material being adapted to change at least one of a measurable electrical property and a measurable optical property when the at least one analyte is present in the sample.

9. The marking method according to claim 8, wherein the at least one radiation-sensitive material comprises at least one material of at least one marking field of the test elements that is different from the test material of the test elements.

10. A test element, comprising:

a test field adapted to detect at least one analyte in a sample and at least one marking field formed separately from the test field, the at least one marking field being comprised of a radiation-sensitive material, wherein radiation causes at least one optically detectable change in the radiation-sensitive material.

11. The test element according to claim 10, wherein the at least one radiation-sensitive material comprises at least one test material of the test elements, the at least one test material being adapted to change at least one of a measurable electrical property and a measurable optical property when the at least one analyte is present in the sample.

12. The test element according to claim 11, wherein the radiation-sensitive material comprises at least one material of the at least one marking field of the test elements that is different from the test material of the test elements.

13. The test element according to claim 10, wherein the optically detectable change comprises at least one other of the following changes:

a color change;

a change of luminescence, in particular fluorescence; and

a change of reflectivity.

14. The test element according to claim 10, wherein the radiation comprises ultraviolet radiation that includes a wavelength range between 250 nm and 400 nm.

15. A production method for producing test elements, the method comprising:

producing a plurality of the test elements adapted to detect at least one analyte in a sample;

providing at least one of the test elements with a defect marking which contains information about defectiveness of the test element when the at least one test element is exposed to radiation; and

subjecting the at least one test element to a defect check to determine whether the test element is defective.

16. The production method according to claim 15, wherein test elements marked as being defective are rejected.

17. The production method according to claim 16, wherein a plurality of test elements are produced as bandware with a common support band.

18. The production method according to claim 15, wherein after providing at least one of the test elements with the defect marking, further comprising inspecting the at least one of the test elements to determine whether the defect marking has been applied correctly.

19. A marking system for marking defective test elements, comprising:

at least one test element adapted to detect at least one analyte in a sample, the at least one test element including a test field and at least one marking field formed separately from the test field, the at least one marking field comprising a radiation-sensitive material; and

a marking device adapted to provide the at least one test element with a defect marking which contains information about defectiveness of the at least one test element, wherein the marking device includes at least one radiation source for exposing the at least one test element to at least one radiation, the radiation being adapted to induce marking in the form of at least one optically detectable change in the radiation-sensitive material.

20. The marking system according to claim 19, further comprising at least one test device, the test device being adapted to subject the at least one test element to a defect check, the marking device further being adapted to determine whether the test element is defective.

21. The marking system according to claim 19, wherein the radiation source comprises a plurality of modularly constructed individual light sources for generating ultraviolet light.

22. The marking system according to claim 19, wherein the marking device comprises at least one application position where the at least one test element is provided with the defect marking, the marking device further comprising at least one light waveguide for conducting the radiation from the radiation source to the application position.

23. The marking system according to claim 22, wherein the waveguide comprises at least one fiber light guide.

24. The marking system according to claim 23, wherein the at least one fiber light guide is a plastic fiber light guide.

25. The marking system according to claim 23, wherein a plurality of fiber light guides are combined to form a fiber bundle, the marking device further including at least one cross-section converter, the cross-section converter being adapted to hold the plurality of fiber light guides of at least one fiber bundle so that fiber ends of the fiber light guides are arranged in a predetermined pattern in the application position.

26. The marking system according to claim 25, wherein the pattern of the fiber ends includes at least one of the following patterns:

a line pattern, a matrix pattern, and a rectangular matrix pattern.

27. The marking system according to claim 22, wherein the marking device includes a guide table in the application position, and at least two test elements being exposable simultaneously to the radiation in the guide table when in the application position.

28. A production system for producing test elements, comprising:

a test element adapted to detect at least one analyte in a sample, the test element including a test field and at least one marking field formed separately from the test field, the at least one marking field comprising a radiation-sensitive material; and

a production device including a fabrication device for producing a plurality of the test elements, the production device further including at least one marking device adapted to provide each of the plurality of test elements with a defect marking which contains information about defectiveness of the test element, wherein the marking device includes at least one radiation source for exposing at least one of the test elements to at least one radiation, the radiation being adapted to induce marking in the form of at least one optically detectable change in the radiation-sensitive material of the at least one test element.

29. The production system according to claim 28, wherein the production device further includes at least one sorting device for rejecting test elements marked as being defective.

30. The production system according to claim 29, wherein the production device further includes a cutting and splicing device.

31. The production system according to claim 30, wherein the production device further includes at least one test device, the test device being adapted to subject the test elements to a defect check.

32. The production system according to claim 28, further comprising an analytical test instrument including at least one interrogation device, the at least one interrogation device being configured to interrogate the defect marking of the test element.

33. The production system according to claim 32, wherein the analytical test instrument is adapted to carry out at least one of the following actions when it is found that a test element is marked as defective:

a warning is sent to a user of the analytical test instrument;

a test with the marked test element is prevented; and

a new test element is provided from a multiplicity of test elements.