Electrochemical test strip cards that include an integral dessicant

• US 6,913,668 B2
• Filed: 03/14/2003
• Issued: 07/05/2005
• Est. Priority Date: 12/20/2000
• Status: Expired due to Fees

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Matzinger, David Parkes
• Primary Examiner(s): GRAY, LINDA LAMEY
• Application Number:
  US10/388,959
• Publication Number:
  US 20030200644A1
• Time in Patent Office: 844 Days
• Field of Search: 156/256, 156/308.2, 156/219, 156/196, 156/252, 156/290, 156/253, 156/513, 156/292, 156/514, 156/310, 204/403.14, 204/403.01, 204/403.02, 204/403.03, 204/404.14, 204/416, 205/777.5, 205/779, 205/787, 205/792
• US Class Current: 156/256
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 33/48778 Containers specially adapted therefor, e.g. for dry storage
• CPC Class Codes: Y10T 156/1056 Perforating lamina
• CPC Class Codes: Y10T 156/1057 Subsequent to assembly of laminae
• CPC Class Codes: Y10T 156/1062 Prior to assembly
• CPC Class Codes: Y10T 156/1309 and securing separate part over hole or aperture
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

Electrochemical test strip cards that can be singulated to produce electrochemical test strips are provided. The electrochemical test cards are made up of two or more electrochemical test strip precursors, where each precursor is characterized by the presence of a dry reagent housing reaction chamber bounded by opposing electrodes. In gaseous communication with each reaction chamber of the card is an integrated desiccant. Also provided are methods of using the subject electrochemical test strips cards, as well as kits that include the same. The subject test strips and cards find use in the detection/concentration determination of a number of different analytes, including glucose.

Claims

1. A method of fabricating an electrochemical test strip card comprising a plurality of test strips configured to be singulated from said test strip card, said method comprising:

providing a top layer, a bottom layer and a spacer layer therebetween, wherein said spacer layer comprises a pattern for each of said plurality of test strips that provides for at least a fluid ingress channel, a reaction chamber, a desiccant chamber, a channel interconnecting said reaction chamber and said a desiccant chamber, and a venting channel;

positioning a desiccant material in said desiccant chamber; and

laminating together said top layer, said bottom layer and said spacer layer.

2. The method of claim 1 further comprising punching a hole in at least said spacer layer to form said desiccant chamber.

3. The method of claim 1 further comprising punching a hole in said top layer, said bottom layer and said spacer layer to form said dessicant chamber.

4. The method of claim 1 wherein said top layer comprises a top surface, a bottom surface and an electrode on said bottom surface and wherein said bottom layer comprises a top surface, a bottom surface and an electrode on said top surface.

5. The method of claim 4 wherein said top layer further comprises a barrier layer on said top surface and wherein said bottom layer further comprises a barrier layer on said bottom surface.

6. The method of claim 1 wherein said desiccant material comprises one or more beads.

7. The method of claim 1 wherein said desiccant material comprises a block.

8. The method of claim 1, further comprising forming a singulation precut in said laminated structure.

9. The method of claim 1, further comprising singulating each of said plurality of test strips from said test strip card.

10. The method of claim 1, wherein said test strip card comprises an information storage means for storing information to be used by a test strip meter with which said test strip card is to be used.

11. The method of claim 10, wherein said information comprises calibration information.

12. The method of claim 11, wherein said information storage means comprises a barcode.

13. The method of claim 1, wherein said test strip card comprises electrical contacts for use with a test strip meter.

14. A method of frabricating an electrochemical test strip card comprising a plurality of test strips configured to be singulated from said test strip card, said method comprising:

providing a top electrode layer, a bottom electrode layer and a spacer layer therebetween, wherein said spacer layer comprises a pattern that provides for at least a fluid ingress channel, a reaction chamber, a location for a desiccant chamber, a channel interconnecting said reaction chamber and said location for a desiccant chamber, and a venting channel;

laminating together said top layer, said bottom layer and said spacer layer;

punching a hole through said laminated structure at said desiccant chamber location thereby forming said desiccant chamber;

positioning a desiccant material in said desiccant chamber; and

providing a first barrier layer on top of said laminated structure and a second barrier layer on the bottom of said laminated structure wherein said descant chamber is in gaseous communication with said reaction chamber.

15. The method of claim 14, further comprising laminating said first and second barriers to said previously laminated structure.

16. The method of claim 14, wherein said top electrode layer comprises a polyester terepthalate substrate having a top surface and a bottom surface and a gold layer on said bottom and wherein said bottom electrode layer comprises a polyester terepthalate substrate having a top surface and a bottom surface and a palladium layer on said top surface and a reagent system on said palladium layer.

17. The method of claim 14 wherein said spacer layer comprises a layer of polyester terepthalate having a top surface and a bottom surface, and a pressure sensitive adhesive on said top surface and said bottom surface.

18. The method of claim 14, wherein the punching of the desiccant chamber comprises forming a fluid stop junction downstream from the reaction chamber.