Test strip coding and quality measurement

• US 7,713,392 B2
• Filed: 04/15/2005
• Issued: 05/11/2010
• 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
• Primary Examiner(s): Wilkins, III; Harry D.
• Assistant Examiner(s): Ripa; Bryan D.
• Application Number:
  US10/907,805
• Publication Number:
  US 20060231417A1
• Time in Patent Office: 1,852 Days
• Field of Search: 204/403.02
• US Class Current: 204/403.02
• 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

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 dimension parallel to a first axis and having a second dimension corresponding to the width of the strip, 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 divided into a plurality of conductively isolated portions, including at least one portion extending from the connection region to the electrochemical cell to provide a conductive path for analysis, and a second portion which is not a conductive path for analysis extending from the connector region towards the electrochemical cell but which does not make contact with sample in the electrochemical cell;

wherein said second portion extends in the first or second dimension for at least one-fifth of the dimension.

2. The strip of claim 1, wherein the conductor has a second portion, separate from the first conductive portion, which is not a conductive path for analysis and which does not make contact with sample in the electrochemical cell;

said second portion extending in the other of the first and second dimension for at least one-fifth of the second dimension.

3. The test strip of claim 1, wherein the first portion extends along the length the axis for at least one-fifth the length of the strip.

4. The test strip of claim 1, wherein the first portion extends across the width of the strip for at least one-fifth the width.

5. 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 an exposed connection region at the other axial end, said exposed connection region being defined by an end edge of the second and/or third planar layers;

the first layer having deposited thereupon a first conductor extending from the exposed 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 exposed connection region.

6. A method of making 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 an exposed connection region at the other axial end, said exposed connection region being defined by an end edge of the second and/or third planar layers;

the method comprising the steps of

depositing upon the first layer a first conductor extending from the exposed 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 exposed 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.