System and method for coding information on a biosensor test strip

• US 8,540,935 B2
• Filed: 05/21/2012
• Issued: 09/24/2013
• Est. Priority Date: 04/01/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Beaty, Terry A., Burke, David W., Celentano, Michael J.
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US13/476,524
• Publication Number:
  US 20120228135A1
• Time in Patent Office: 491 Days
• Field of Search: 422/400, 422/50, 204/403.02, 204/403.01, 204/400, 204/194, 204/193
• US Class Current: 422/50
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 2035/00851 process control parameters
• 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

The present invention provides a test strip for measuring a concentration of an analyte of interest in a biological fluid, wherein the test strip may be encoded with information that can be read by a test meter into which the test strip is inserted. In one embodiment, a first test strip comprises: a first measurement electrode connectable to a test meter; a first trace loop with a first associated resistance, where the first trace loop is connectable to the test meter; and a second trace loop with a second associated resistance, where the second trace loop is connectable to the test meter. The test meter is adapted to: receive the first test strip; connect to the first measurement electrode, the first trace loop, and the second trace loop; and obtain a first resistance ratio by comparing the first and second associated resistances.

Claims

1. An electrochemical test strip for measuring a concentration of an analyte of interest in a biological fluid, the test strip comprising:

a substrate;

a plurality of data encoded on the test strip;

a measurement electrode formed on the substrate;

a first trace loop formed on the substrate, the first trace loop having a first associated resistance;

a second trace loop formed on the substrate, the second trace loop having a second associated resistance, wherein the first and second resistances define a first resistance ratio corresponding to at least one of the plurality of data encoded on the test strip; and

at least a third trace loop formed on the substrate, the identity of which of the plurality of encoded data corresponds to the first resistance ratio being indicated by at least one of the following;

a. connection or lack of connection between the third trace loop and another trace loop,

b. the resistance associated with the third trace loop, and

c. the ratio of the resistance of the third trace loop with the resistance of another trace loop.

2. The electrochemical test strip of claim 1 in which the third trace loop is connected to only the first trace loop, the connection between the third trace loop and the first trace loop, and the lack of connection between the third trace loop and the second trace loop, indicating which of the plurality of data corresponds to the first resistance ratio.

3. The electrochemical test strip of claim 1 in which the third trace loop is connected to both the first trace loop and the second trace loop, the connection between the third trace loop with both the first and second trace loops indicating which of the plurality of data corresponds to the first resistance ratio.

4. The electrochemical test strip of claim 1 in which the third trace loop is connected to only the first trace loop, said test strip further comprising:

a fourth trace loop formed on the substrate and connected to only the first trace loop, only the second trace loop, or both the first and second trace loops, the connection between the third trace loop and the first trace loop, together with the connection between the fourth trace loop and one or more other trace loops, indicating which of the plurality of data encoded on the test strip corresponds to the first resistance ratio.

5. The electrochemical test strip of claim 4 in which the fourth trace loop is connected to the first trace loop.

6. The electrochemical test strip of claim 4 in which the fourth trace loop is connected to the second trace loop.

7. The electrochemical test strip of claim 4 in which the fourth trace loop is only connected to the second trace loop.

8. The electrochemical test strip of claim 1 and further comprising:

a fourth trace loop formed on the substrate, the connection or lack of connection between the third trace loop and the fourth trace loop indicating which of the plurality of data corresponds to the first resistance ratio.

9. The electrochemical test strip of claim 8 in which the fourth trace loop is connected to the third trace loop.

10. The electrochemical test strip of claim 1 in which the third trace loop has a third associated resistance, the third resistance indicating which of the plurality of data corresponds to the first resistance ratio.

11. The electrochemical test strip of claim 1 in which the third trace loop has a third associated resistance, the first and third resistances defining a second resistance ratio indicating which of the plurality of data corresponds to the first resistance ratio.

12. The electrochemical test strip of claim 1 in which the third trace loop has a third associated resistance, said test strip further comprising:

a fourth trace loop formed on the substrate and having a fourth associated resistance, the third and fourth resistances defining a second resistance ratio indicating which of the plurality of data corresponds to the first resistance ratio.

13. The electrochemical test strip of claim 1, wherein the plurality of data includes data indicative of one or more of the following:

what analyte the respective test strip is designed to measure,

what biological fluid the respective test strip is designed to receive,

what calibration data is to be used with the respective test strip,

what production lot the respective test strip was manufactured in,

a calibration family of the respective test strip,

a reagent disposed on the respective test strip,

a geographic market in which the respective test strip is to be sold,

a geographic market in which the respective test strip was manufactured,

a display language to be used by a test meter into which the respective test strip is to be inserted,

user operating instructions to be displayed by a test meter into which the respective test strip is to be inserted,

that the respective test strip is to be sold on a subscription basis,

that the respective test strip is not to be sold on a subscription basis,

a latent feature to be activated by a test meter when the respective test strip is inserted into the test meter,

that the respective test strip is to be sold in a hospital market, and

that the respective test strip is to be sold in a consumer market.

14. The electrochemical test strip of claim 1, wherein the trace loops are selected from the group consisting of:

conductive ink, screen printed thick film hybrid resistor, fixed value thick film resistor, and fixed value thin film resistor.

15. The electrochemical test strip of claim 1, wherein the resistances of the trace loops are determined by one or more items selected from the group consisting of:

the dimensions of the respective trace loop,

the material from which the respective trace loop is made, and

at least one resistive element bridging a gap in the trace loop.