test strip coding and quality measurement

• US 20060231417A1
• Filed: 04/15/2005
• Published: 10/19/2006
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• 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: Diamond, Steven, Harding, Ian, Iyengar, Sridhar, Wei, Baoguo, Forest, Martin
• Granted Patent: US 7,713,392 B2
• Time in Patent Office: Days
• US Class Current: 205/775
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/545 for laboratory containers
• 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

Abstract

Abstract of the Disclosure

A test strip and analytical apparatus have pin connections permitting the definition of geographic regions or of particular customers. A test strip made for use in a particular region or for a particular customer will have pin connections matching features of the apparatus made for use in that region or by that customer. Insertion of the strip into the apparatus does not merely turn on the apparatus, but provides the regional or customer coding. Analog switches within the apparatus allow coding of a larger number of distinct regions or customers than would otherwise be possible, all without degrading the quality of the measurements made of the fluid being tested. Conductive paths in the strips permit testing the strips during manufacture so as to detect quality lapses regarding the printing or deposition of the paths.

Claims

1. A planar test strip elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the strip made up of at least a first layer;

the first layer having deposited thereupon at least one conductor extending from the connection region to the electrochemical cell,

the conductor having a first portion which is not a conductive path for analysis;

said first portion extending along the axis for at least one-fifth of the length of the strip.

2. The strip of claim 1 wherein the strip has a width, and wherein the conductor has a second portion which is not a conductive path for analysis;

said second portion extending perpendicular to the axis for at least one-fifth of the width of the strip.

3. A planar test strip elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the strip having a width, the strip made up of at least a first layer;

the first layer having deposited thereupon at least one conductor extending from the connection region to the electrochemical cell,

the conductor having a first portion which is not a conductive path for analysis;

said first portion extending perpendicular to the axis for at least one-fifth of the width of the strip.

4. The strip of claim 3 wherein the conductor has a second portion which is not a conductive path for analysis;

said second portion extending along the axis for at least one-fifth of the length of the strip.

5. A method for use with a planar test strip elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the strip made up of at least a first layer;

the first layer having deposited thereupon at least one conductor extending from the connection region to the electrochemical cell, the conductor having a first portion which is not a conductive path for analysis;

the method comprising the step of;

applying first and second test probes to said first portion, said first and second test probes disposed axially and separated by least one-fifth of the length of the strip.

6. The method of claim 5 wherein the strip has a width, and wherein the conductor has a second portion which is not a conductive path for analysis, the method further comprising the step of:

applying third and fourth test probes to said second portion, said third and fourth test probes disposed perpendicular to the axis and separated by at least one-fifth of the width of the strip.

7. A method for use with a planar test strip elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the strip having a width, the strip made up of at least a first layer;

the first layer having deposited thereupon at least one conductor extending from the connection region to the electrochemical cell, the conductor having a first portion which is not a conductive path for analysis;

the method comprising the step of;

applying first and second test probes to said first portion, said first and second test probes disposed perpendicular to the axis and separated by at least one-fifth of the width of the strip.

8. The method of claim 7 wherein the conductor has a second portion which is not a conductive path for analysis, the method further comprising the step of:

applying third and fourth test probes to said second portion, said third and fourth test probes disposed axially and separated by least one-fifth of the length of the strip.

9. A method for use with a test strip and a meter, the test strip elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the connection region comprising a plurality of connections, the meter comprising a connector disposed to mate with the connection region of the connections with pins corresponding thereto;

the method comprising the steps of;

determining, within the meter, whether predefined first and second pins of the strip are connected, defining a first finding;

determining, within the meter, whether a predefined third pin is not connected to either of the first and second pins, defining a second finding;

and

performing the analysis only in the event that the first and second findings are in the affirmative.

10. A planar test strip elongated for a length along a first axis, the strip comprising at least first, second, and third planar layers, the second planar layer lying between the first and third planar layers;

the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end;

the first layer having deposited thereupon a first conductor extending from the connection region to the electrochemical cell, the first layer also having deposited thereupon a second conductor extending nearby to but not in conductive relationship to the first conductor;

the strip further comprising an electrochemical reagent deposited upon the first layer, the reagent extending to lie atop a portion of the first conductor and extending to lie atop a portion of the second conductor;

the second conductor not in conductive relationship to the connection region.

11. A method for use with a planar test strip elongated for a length along a first axis, the strip comprising at least first, second, and third planar layers, the second planar layer lying between the first and third planar layers;

the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end;

the method comprising the steps of;

depositing upon the first layer a first conductor extending from the connection region to the electrochemical cell,

depositing upon the first layer a second conductor extending nearby to but not in conductive relationship to the first conductor, the second conductor not in conductive relationship to the connection region;

and

depositing upon the first layer an electrochemical reagent, the reagent extending to lie atop a portion of the first conductor and extending to lie atop a portion of the second conductor.