Marking method for the reject marking of test elements

• US 8,618,511 B2
• Filed: 09/18/2008
• Issued: 12/31/2013
• 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: Finke, Werner, Frank, Martin, Dick, Siegfried, Stubenbord, Peter, Rper, Josef K., Schmidt, Gnter
• Primary Examiner(s): Porta, David
• Assistant Examiner(s): LEE, SHUN K
• Application Number:
  US12/212,874
• Publication Number:
  US 20090090874A1
• Time in Patent Office: 1,930 Days
• Field of Search: 250/474.1
• US Class Current: 250/474.1
• 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 digital information indicating the test elements are defective or non-defective, wherein the test elements include at least one radiation-sensitive material;

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

wherein the at least one radiation-sensitive material is a test material of the test elements, wherein the test material defines the analytical functionality of a field of the test element and is 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.

2. The marking method according to claim 1, wherein the defect marking provides only a binary or two-state status of the test elements indicating whether or not the test elements include one or more non-tolerable defects.

3. 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;

a marking device adapted to provide the at least one test element with a defect marking which contains digital information indicating the at least one test element is defective or non-defective, 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; and

wherein the at least one radiation-sensitive material is a test material of the test elements, wherein the test material defines the analytical functionality of a field of the test element and is 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.

4. The marking system according to claim 3, wherein the defect marking provides only a binary or two-state status of the at least one test element indicating whether or not the at least one test element includes one or more non-tolerable defects.

5. The marking system according to claim 3, 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 test device further being adapted to determine whether the test element includes one or more non-tolerable defects.

6. The marking system according to claim 3, wherein the radiation source comprises a plurality of modularly constructed individual light sources for generating ultraviolet light.

7. The marking system according to claim 3, 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.

8. The marking system according to claim 7, 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.

9. The marking system according to claim 7, wherein the waveguide comprises at least one fiber light guide.

10. The marking system according to claim 9, wherein the at least one fiber light guide is a plastic fiber light guide.

11. The marking system according to claim 9, 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.

12. The marking system according to claim 11, 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.

13. 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 reject marking in response to determining the test elements are defective, wherein the test elements include a radiation-sensitive test material 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; and

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

14. The marking method according to claim 13, wherein the at least one radiation comprises electromagnetic radiation.

15. The marking method according to claim 14, wherein the electromagnetic radiation is ultraviolet radiation.

16. The marking method according to claim 15, wherein the ultraviolet radiation includes a wavelength range between 250 nm and 400 nm.

17. The marking method according to claim 15, wherein the ultraviolet radiation includes a wavelength range from 350 nm to 380 nm.

18. The marking method according to claim 13, wherein at least one of the following light sources is used to generate the at least one radiation:

an incandescent lamp;

a gas discharge lamp;

a laser;

a light-emitting diode; and

a flash lamp.

19. The marking method according to claim 13, wherein the at least one optically detectable change comprises at least one of the following changes:

a color change;

a change of luminescence;

a change of fluorescence; and

a change of reflectivity.

20. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to deformation of the test elements.

21. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to incorrect application of a test material on the test elements.

22. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to an inhomogeneous test field on the test elements.

23. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to a non-constant layer thickness of a test field of the test elements.

24. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to an improper positioning of a test field on the test elements.

25. The marking method according to claim 13, wherein the reject marking indicates the test elements include a non-tolerable defect due to one or more of an electrical defect and an electrochemical defect of a test material of the test elements.

26. 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 radiation-sensitive test material 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; and

a marking device adapted to provide the at least one test element with a reject marking in response to determining the at least one test element is defective, 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 test material.