Marking method for the reject marking of test elements

Patent metadata

Field	Value
Publication number	US-10535442-B2
Application number	US-201314104614-A
Country	US
Kind code	B2
Filing date	Dec 12, 2013
Priority date	Sep 19, 2007
Publication date	Jan 14, 2020
Grant date	Jan 14, 2020

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.

First claim

The invention claimed is:

1. A marking method for marking analyte-detecting test elements to identify defective test elements based on their having at least one non-tolerable defect rendering them unsuited for use in conducting an analyte test, comprising:
providing a plurality of test elements, each test element including a reagent adapted to detect at least one analyte in a sample, the reagent of each of the plurality of test elements comprising a radiation-sensitive material;
identifying, among the plurality of test elements including the radiation-sensitive material, defective test elements determined to include one or more non-tolerable defects; and
in response to the identification of the defective test elements, exposing the radiation-sensitive material of only the defective or only the non-defective test elements to a marking radiation, the marking radiation providing a detectable change in a measurable property of the radiation-sensitive material to provide a marking distinguishing the defective test elements from the non-defective test elements.

2. The marking method of claim 1 in which the marking radiation changes a measurable optical property of the radiation-sensitive material.

3. The marking method of claim 1 comprising, after exposing the test elements to the marking radiation, inspecting the test elements to determine whether the marking has been applied correctly.

4. The marking method of claim 1 in which said exposing is exposing only the defective test elements to the marking radiation to provide a reject marking on each defective test element.

5. The marking method according to claim 4 , wherein the reject marking indicates the test elements include a non-tolerable defect due to deformation of the test elements.

6. The marking method according to claim 4 , 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.

7. The marking method according to claim 4 , wherein the reject marking indicates the test elements include a non-tolerable defect due to an inhomogeneous test field on the test elements.

8. The marking method according to claim 4 , 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.

9. The marking method according to claim 4 , 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.

10. The marking method according to claim 4 , 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.

11. The method of claim 1 in which the plurality of test elements include both the defective test elements and the non-defective test elements, the method further including testing each of the test elements to distinguish between the defective test elements and the non-defective test elements, said exposing comprising irradiating the radiation to only the defective test elements or the non-defective test elements.

12. The method of claim 11 in which providing comprises providing a cassette of the test elements.

13. The method of claim 1 and including a post-production inspection of the test elements to identify the detective test elements.

14. The method of claim 1 and which further includes checking each test element for the presence said detectable change in a measurable property of the radiation-sensitive material and in response to the detectable change rejecting the test element.

15. The method of claim 1 in which the defective test elements are rejected based on the marking.

16. The method of claim 15 in which defective test elements are separated from the non-defective test elements based on the marking of the test elements.

17. A method for producing test elements as components of bandware with a common support band and including both defective and non-defective test elements, comprising:
producing a plurality of analyte-detecting test elements, each test element including a reagent adapted to detect at least one analyte in a sample, the reagent of each test element including a radiation-sensitive material;
following the producing step, identifying defective test elements present with non-defective test elements in the plurality of analyte-detecting test elements based on the defective test elements having at least one non-tolerable defect rendering them unsuited for use in conducting an analyte test;
in response to the identification of the defective test elements, exposing the radiation-sensitive material of only the defective or only the non-defective test elements to a marking radiation, the marking radiation providing a detectable change in a measurable property of the radiation-sensitive material to provide a marking on only the test elements exposed to the marking radiation; and
removing defective test elements from the bandware based on the marking of the test elements.

18. The method of claim 17 in which the defective test elements are rejected based on the marking.

19. The method of claim 18 in which defective test elements are separated from the non-defective test elements based on the marking of the test elements.

20. The method of claim 17 in which said exposing is exposing to marking radiation which changes a measurable optical property of the radiation-sensitive material.

21. The marking method of claim 17 in which the test elements include a reagent adapted to detect at least one analyte in a sample and the radiation-sensitive material is located in the reagent.

22. The method of claim 21 in which said exposing is exposing to marking radiation which changes a measurable optical property of the reagent.

Assignees

• Roche Diabetes Care Inc

Inventors

• Roper Josef K
• Finke Werner
• Frank Martin
• Schmidt Gunter
• Dick Siegfried
• Stubenbord Peter

Classifications

• Y10T29/53022

  with means to test work or product · CPC title

• G21K5/00 Primary

  Irradiation devices (discharge tubes for irradiating H01J37/00) · CPC title

• G01N35/00029

  provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence) · CPC title

• G01N35/00732

  Identification of carriers, materials or components in automatic analysers · CPC title

• G01N2035/00108

  Test strips, e.g. paper · CPC title