System and method for coding information on a biosensor test strip

• US 20050016845A1
• Filed: 06/18/2004
• Published: 01/27/2005
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Groll, Henning, Celentano, Michael J., Moore, Steven K.
• Granted Patent: US 8,206,565 B2
• Time in Patent Office: Days
• US Class Current: 204/403.100
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/545 for laboratory containers
• 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.

Claims

1. A method for forming a test strip for measuring a concentration of an analyte of interest in a biological fluid, the method comprising the steps of:

providing a basic test strip design comprising;

a substrate having a surface and at least one measurement electrode formed thereon;

a plurality of conductive contact pads formed upon the substrate surface; and

a plurality of potential conductive links conductively coupling members of the plurality of contact pads;

wherein at least two of the potential conductive links occupy paths that cross one another;

defining a set of valid test strip designs;

wherein each one of the set of valid test strip designs incorporates none, one, or more than one of the plurality of potential conductive links;

selecting one design from the set of valid test strip designs; and

forming a test strip per the selected one design.

2. The method of claim 1, wherein:

the plurality of conductive contact pads comprises;

a plurality of measurement contact pads, each being conductively coupled to the at least one measurement electrode by a conductive path that excludes the plurality of potential conductive links, and

a plurality of information contact pads, each being conductively coupled to the at least one measurement electrode only by conductive paths comprising at least one of the plurality of potential conductive links; and

wherein each of the at least two potential conductive links that occupy paths that cross one another connect one of the plurality of measurement contact pads and one of the plurality of information contact pads.

3. The method of claim 1, wherein the step of defining a set of valid test strip designs includes the sub-steps of:

identifying at least one variation between the test strips formed by the method that effects an output signal corresponding to the analyte;

assigning exactly one permutation of the at least one variation to correspond to each of the valid test strip designs; and

wherein the step of selecting one design from the set of valid test strip designs requires selecting a design that corresponds to the permutation of the at least one variation that characterizes the test strip.

4. A method for forming a test strip for measuring a concentration of an analyte of interest in a biological fluid, the method comprising the steps of:

providing a basic test strip comprising;

a substrate having a surface and at least one measurement electrode formed thereon;

a plurality of conductive contact pads formed upon the substrate surface, including;

a plurality of information contact pads; and

a plurality of measurement contact pads that are conductively coupled to the at least one measurement electrode;

a plurality of severable conductive links conductively coupling at least one of the plurality of information contact pads and at least one of the plurality of measurement contact pads, and conductively coupling at least one of the plurality of measurement contact pads with another of the plurality of measurement contact pads;

severing at least one of the severable conductive links, thereby severing each of the plurality of measurement contact pads from all of the others;

wherein the at least one information contact pad is not coupled to any of the at least one measurement electrodes except by conductive paths comprising the plurality of severable conductive links.

5. A test strip for measuring a concentration of an analyte of interest in a biological fluid, the test strip comprising:

a substrate having a surface and at least one measurement electrode formed thereon;

a plurality of conductive contact pads formed upon the substrate surface, including;

a plurality of severable conductive links conductively coupling members of the plurality of contact pads,

wherein the plurality of conductive contact pads comprise;

a plurality of measurement contact pads, each of which is conductively coupled to the at least one measurement electrode; and

a plurality of information contact pads, each of which is conductively coupled to the at least one measurement electrode only through one or more severable links; and

wherein at least two of the severable conductive links occupying paths that cross one another;

wherein any conductive path formed between a pair of the plurality of measurement contact pads is severed by severing at least one of the severable conductive links.

6. The test strip of claim 5, wherein each of the severable conductive links connects one of the plurality of measurement contacts pads with one of the plurality of information contact pads.

7. The test strip of claim 5, wherein the at least one of the severable conductive links that is severed is selected according to a characteristic of the test strip.

8. The test strip of claim 7, wherein the characteristic of the test strip is a calibration curve that provides for more accurate readings when the test strip is used for measuring the analyte.