Electrochemical test strip cards that include an integral dessicant

• US 6,558,528 B1
• Filed: 12/20/2000
• Issued: 05/06/2003
• Est. Priority Date: 12/20/2000
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Matzinger, David Parkes
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/746,116
• Time in Patent Office: 867 Days
• Field of Search: 204/403-1-4, 204/416-419, 205/777.5, 205/789, 205/775, 205/792, 422/82-1-
• US Class Current: 205/777.5
• 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. An electrochemical test strip card, said card comprising;

at least two electrochemical test strip precursors configured to be singulated from said card, wherein each of said precursors comprises;

(a) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(b) an integrated desiccant;

wherein prior to singulation of said card and during use of an electrochemical test strip, each reaction chamber is in gaseous communication with a desiccant of said card.

2. The electrochemical test strip card according to claim 1, wherein each electrochemical test strip precursor further comprises a desiccant chamber that houses a desiccant material.

3. The electrochemical test strip card according to claim 2, wherein said desiccant chamber is in gaseous communication with a reaction chamber on the same precursor.

4. The electrochemical test strip card according to claim 1, wherein said desiccant has a capacity of at least about 0.5 mg per test.

5. The electrochemical test strip card according to claim 1, wherein said desiccant comprises an indicator.

6. The electrochemical test strip card according to claim 1, wherein said card is configured such that singulation of a precursor from said card provides a singulated electrochemical test strip having fluid entry and exit channels into said reaction chamber of said singulated electrochemical test strip.

7. The electrochemical test strip card according to claim 1, wherein said test strip card is sealed in a fluid barrier material.

8. The electrochemical test strip card according to claim 1, wherein said reagent composition comprises a redox reagent system comprising an enzyme and a mediator.

9. An electrochemical test strip comprising:

(a) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(b) a desiccant integrated into said electrochemical test strip wherein during use of said electrochemical test strip said reaction chamber is in gaseous communication with said desiccant.

10. The electrochemical test strip according to claim 9, wherein said electrochemical test strip further comprises a desiccant chamber that houses said desiccant.

11. The electrochemical test strip according to claim 9, wherein said desiccant has a capacity of at least about 0.5 mg per test.

12. The electrochemical test strip according to claim 9, wherein said desiccant comprises an indicator.

13. The electrochemical test strip according to claim 9, wherein said reagent composition comprises a redox reagent system that includes an enzyme and a mediator.

14. A method for determining the concentration of an analyte in a physiological sample, said method comprising:

(a) introducing said physiological sample into an electrochemical test strip comprising;

(i) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(ii) a desiccant integrated into said electrochemical test strip;

(b) detecting an electrical signal in said reaction zone using said electrodes; and

(c) relating said detected electrical signal to the amount of said analyte in said sample.

15. The method according to claim 14, wherein said physiological sample is whole blood or a derivative thereof.

16. The method according to claim 14, wherein said analyte is glucose.

17. The method according to claim 14, wherein said reagent composition comprises a redox reagent system comprising an enzyme and a mediator.

18. The method according to claim 14, wherein said method further comprises singulating a test strip card to produce said electrochemical test strip prior to said introducing step (a).

19. The method according to claim 14, wherein said detecting an electrical signal and said relating said detected electrical signal are performed by an automated device.

20. A method for determining the concentration of an analyte in a physiological sample, said method comprising:

(a) singulating an electrochemical test strip card to produce an electrochemical test strip, said card comprising at least two electrochemical test strip precursors, wherein each of said precursors comprises;

(i) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(ii) an integrated desiccant;

prior to singulation of said card, each reaction chamber is in gaseous communication with a desiccant of said card;

(b) following said singulation, introducing said physiological sample into said singulated electrochemical test strip;

(c) detecting an electrical signal in said reaction zone using said electrodes; and

(d) relating said detected electrical signal to the amount of said analyte in said sample.

21. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) an electrochemical test strip card comprising at least two electrochemical test strip precursors configured to be singulated from said test strip card, wherein each of said precursors comprises;

(i) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(ii) an integrated desiccant;

 

wherein prior to after singulation of said card each reaction chamber is in gaseous communication with said integrated dessicant; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

(ii) an analyte standard.

22. The kit according to claim 21, wherein said kit further comprises a meter.

23. A system for use in determining the concentration of an analyte in a physiological sample, said system comprising:

(a) an electrochemical test strip comprising;

(i) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(ii) a desiccant integrated into said electrochemical test strip wherein during use of said electrochemical test strip said reaction chamber is in gaseous communication with said desiccant; and

(b) a meter.

24. An electrochemical test strip card, said card comprising;

at least two electrochemical test strip precursors configured to be singulated from said card, wherein each of said precursors comprises;

(a) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(b) a desiccant chamber housing a desiccant material;

wherein prior to singulation of said card, each reaction chamber is in gaseous communication with a desiccant of an adjacent percursor.

25. The electrochemical test strip card according to claim 24, wherein when said electrochemical test strips are singulated, each comprises a reaction chamber that is not in gaseous communication with a desiccant chamber.

26. The electrochemical test strip according to claim 25, wherein said strip is present in a meter.

27. An electrochemical test strip comprising:

(a) a reaction chamber bounded by opposing electrodes and comprising a reagent composition; and

(b) a desiccant chamber housing a desiccant, wherein said desiccant chamber is not in gaseous communication with said reaction chamber.