Encoded biosensors and methods of manufacture and use thereof

• US 8,888,973 B2
• Filed: 07/29/2011
• Issued: 11/18/2014
• Est. Priority Date: 07/29/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Austera, John T., Beaty, Terry A., Joseph, Abner D., Moore, Steven K., Pauley, James L. Jr., Riggles, Randall K., Manlove, Nathan E.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/194,031
• Publication Number:
  US 20130027064A1
• Time in Patent Office: 1,208 Days
• Field of Search: 20440301-40315, 205/777.5, 205/792, 422/82.01, 422/82.02, 435 4- 40, 600345-361
• US Class Current: 204/403.02
• 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 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

An analyte test sensor strip is disclosed having information coded thereon as well as a method of forming the same and conducting an analyte test using the analyte test sensor strip. Information relating to an attribute of the strip or batch/lot of strips may be coded based on resistance values pertaining to electrical aspects of the strip, such as a primary resistive element and a secondary resistive element, the secondary resistive element having one of a plurality of states defined by a location of a closed tap to form a unique resistive path for the secondary resistive element that includes a portion of the primary resistive element depending on the location of the closed tap. The states may be formed on the strip by a secondary processing step in the manufacture of the strip in which a plurality of taps are severed leaving only one tap in a closed state.

Claims

1. An analyte test sensor strip, comprising:

a non-conductive substrate;

means for conducting quantitative or qualitative analysis of an analyte in a sample of fluid; and

an information circuit provided on said non-conductive substrate, said information circuit comprising;

a conductive primary path between a first end and a second end having a predetermined configuration between said first and second ends, wherein said conductive primary path has a resistance falling within a first predetermined range; and

a conductive secondary path between said first end of said conductive primary path and a third end, wherein said conductive secondary path is substantially defined by a plurality of open taps and a closed tap, wherein said closed tap selectively connects said third end with said conductive primary path at a predetermined location thereby defining a unique resistive path between the first end and the third end through at least a portion of said conductive primary path, wherein said unique resistive path has a second resistance falling within a second predetermined range;

wherein a ratio of said first resistance and said second resistance selectively correlates to an attribute of said analyte test sensor strip.

2. The analyte test sensor strip of claim 1, wherein said first end is connected with a first contact pad, said second end is connected with a second contact pad, and said third end is connected with a third contact pad.

3. The analyte test sensor strip of claim 1, wherein said predetermined configuration comprises a serpentine configuration having a plurality of proximal ends and a plurality of distal ends.

4. The analyte test sensor strip of claim 3, wherein said closed tap is connected to a respective proximal end.

5. The analyte test sensor strip of claim 1, wherein which tap comprises said closed tap is selected as a function of an attribute of said analyte test sensor strip.

6. The analyte test sensor strip of claim 1, further comprising an optical code on said non-conductive substrate.

7. The analyte test sensor strip of claim 6, wherein said optical code contains at least one informational attribute associated with said analyte test sensor strip selected from the group consisting of a product expiration date, a product identification, intercepts of blood and control solution information, a strip lot identification, and a strip performance algorithm identifier.

8. A method for measuring a concentration of an analyte in a sample of fluid, comprising:

providing a test meter;

providing a test strip, said test strip comprising;

a non-conductive substrate;

a working electrode on said non-conductive substrate connectable to said test meter;

a counter electrode on said non-conductive substrate connectable to said test meter;

a reagent part bridging between said working electrode and said counter electrode;

a primary resistive element on said non-conductive substrate having a first end connectable to said test meter and a second end connectable to said test meter, wherein said primary resistive element has a predetermined configuration; and

a secondary resistive element on said non-conductive substrate having a third end connectable to said test meter, wherein said secondary resistive element has a plurality of taps, wherein a respective one of said taps is connected to said primary resistive element at a predetermined connection point on said predetermined configuration thereby defining a unique resistive path through at least a portion of said predetermined configuration having a resistance value;

receiving said test strip into the test meter;

operatively connecting said working electrode, said counter electrode, said primary resistive element, and said secondary resistive element with said test meter;

determining an attribute associated with test strip as a function of a measurement associated with at least said resistance value associated with said unique resistive path;

configuring said test meter as a function of said attribute; and

displaying a measurement of said concentration of said analyte on a display of said test meter;

wherein said primary resistive element has a primary element resistance value and said attribute is determined as a function of a resistance ratio determined by comparing said resistance value of said unique resistive path with said primary element resistance value.

9. The method of claim 8, wherein an end of said primary resistive element is connected with said counter electrode.