Identification Method for Electrochemical Test Strips

• US 20090095623A1
• Filed: 10/09/2008
• Published: 04/16/2009
• Est. Priority Date: 10/10/2007
• Status: Abandoned Application

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Boiteau, Charles, Iyengar, Sridhar, Wei, Baoguo, Forest, Martin
• Application Number:
  US12/248,195
• Publication Number:
  US 20090095623A1
• Time in Patent Office: Days
• US Class Current: 204/403.01
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention provides a method and apparatus for creating test strips that may be identified based on differences in electrical conduction or resistance between contact point on the test strip. This is achieved by creating a base test strip with contact points that may be connected to other contact points by an electrical connection. These base test strips may be modified to create a difference in electrical conductivity between contact points, or a contact point may be eliminated. This modification can be used to distinguish different types of test strips based on electrical signature. Additionally, the base test strip may be created such that multiple modifications are possible to distinguish numerous characteristics of test strips.

Claims

1. A method of making a plurality of test strips wherein said test strips are part of a base test strip group or a modified test strip group distinguishable from the base group comprising

creating a plurality of base test strips, each with a region of electrically conductive material, and a plurality of accessible contact points connected to one another by said electrically conductive material;

and

modifying a portion of the base test strips by physical removal of electrically conductive material or at least one contact point to create a first modified test strip group wherein the test strip within the modified test strip group is distinguishable from the base test strip due to a difference in electrical conductivity/resistance between the contact points.

2. The method of claim 1 further comprising the step of modifying an additional portion of the base test strips by removal of electrically conductive material or at least one contact point to create an additional modified test strip group distinguishable from the base test strip and the first modified test strip group.

3. The method of claim 2 further comprising

testing representative base test strips of a lot to determine whether the lot meets a specification;

assigning the strips of the lot to a group based on meeting the specification; and

modifying test strips assigned to a modified test strip group to indicate the group.

4. The method of claim 3 where the specification indicates that the test strip is of a suitable quality as to be used without calibration.

5. The method of claim 3 where said test strips are used to detect glucose.

6. The method of claim 1 further comprising

testing representative base test strips of a lot to determine whether the lot meets a specification;

assigning the strips of the lot to a group based on meeting the specification; and

modifying test strips assigned to a modified test strip group to indicate the group.

7. The method of claim 6 where said test strips are used to detect glucose.

8. The method of claim 1 where said test strips are used to detect glucose.

9. The method of claim 6 where the specification indicates that the test strip is of a suitable quality as to be used without calibration.

10. The method of claim 1 wherein the base test strips have contact points arranged in two or more groups, each at a different depth from an end of the test strip.

11. The method of claim 10 wherein

the base test strips have five contact points, arranged in two rows, with a first row having two contact points at a lesser depth from the end of the test strip and a second row with three contact points at a greater depth from the end of the test strip;

a region of insulating material separates one of the contact points in the second row from the other two contact points in the second row; and

said insulating material partially separates the first row and second row of contact points.

22. A family of test strips comprising a base test strip group and at least one modified test strip group where

said base test strip has a region of electrically conductive material, and a plurality of accessible contact points connected to one another by said electrically conductive material;

and

a modified test strip group comprising a base test strip modified by physical removal of electrically conductive material or at least one contact point wherein the modified test strip is distinguishable from the base test strip due to a difference in electrical conductivity/resistance between the contact points.

12. The family of test strips of claim 22 further comprising an additional modified test strip group where a portion of the base test strip is modified by removal of electrically conductive material or at least one contact point and the additional modified test strip group is distinguishable from the base test strip and the first modified test strip group.

13. The family of test strips of claim 12 wherein test strips in one of the base test strip group and the first modified group meet a specification and those in the other group do not meet the specification, wherein meeting the specification is determined by testing of representative samples from a lot.

14. The method of claim 13 where the specification indicates that the test strip is of a suitable quality as to be used without calibration.

15. The method of claim 13 where said test strips are used to detect glucose.

16. The family of test strips of claim 22 wherein test strips in one of the base test strip group and the first modified group meet a specification and those in the other group do not meet the specification, wherein meeting the specification is determined by testing of representative samples from a lot.

17. The method of claim 16 where the specification indicates that the test strip is of a suitable quality as to be used without calibration.

18. The method of claim 16 where said test strips are used to detect glucose.

19. The method of claim 22 where said test strips are used to detect glucose.

20. The family of test strips from claim 22 where test strips in each group are manufactured for a different geographic region.

21. The family of test strips from claim 22 where test strips in each group are manufactured for a different type of meter.