Electrochemical biosensor test strip

• US 6,270,637 B1
• Filed: 08/31/1999
• Issued: 08/07/2001
• Est. Priority Date: 12/05/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Diebold, Eric R., Ho, Jiaxiong Jason, McMinn, Daniel R., Surridge, Nigel A., Bodensteiner, Richard J., Delk, R. Dale, Crismore, William F., Burke, David W., Heald, Brian A., Earl, Robert Kitchel
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/386,210
• Time in Patent Office: 707 Days
• Field of Search: 204/400, 204/403, 204/416, 204/421, 422/57, 422/61, 436/164, 436/169, 436/166, 436/150
• US Class Current: 204/403.04
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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 33/5438 Electrodes
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode

Abstract

An electrochemical biosensor test strip with four new features. The test strip includes an indentation for tactile feel as to the location of the strips sample application port. The sample application port leads to a capillary test chamber, which includes a test reagent. The wet reagent includes from about 0.2% by weight to about 2% by weight polyethylene oxide from about 100 kilodaltons to about 900 kilodaltons mean molecular weight, which makes the dried reagent more hydrophilic and sturdier to strip processing steps, such as mechanical punching, and to mechanical manipulation by the test strip user. The roof of the capillary test chamber includes a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test. The test strip may further include a notch located at the sample application port. The notch reduces a phenomenon called “dose hesitation”.

Claims

1. An electrochemical test strip comprising electrodes;

and

a reagent comprising reaction components appropriate for performing a test, and a dissolvable or suspendable film forming mixture including polyethylene oxide having a mean molecular weight from about 100 kilodaltons to about 900 kilodaltons,

wherein the reagent is applied to the test strip in a wet form, and subsequently dried, and thereby adapted to be redissolved or resuspended upon addition of an aqueous test sample to the dried reagent.

2. The electrochemical test strip of claim 1, wherein the mean molecular weight of polyethylene oxide is about 300 kilo Daltons.

3. The electrochemical test strip of claim 1, wherein the reaction components appropriate for performing the test include an enzyme quinoprotein glucose dehydrogenase and a redox mediator ferricyanide.

4. The electrochemical test strip of claim 1, wherein the reaction components appropriate for performing a test include an enzyme quinoprotein glucose dehydrogenase and a redox mediator ferricyanide.

5. The electrochemical test strip of claim 4, wherein the enzyme quinoprotein glucose dehydrogenase comprises a stabilized association of coenzyme PQQ and the apoenzyme of quinoprotein glucose dehydrogenase.

6. The electrochemical test strip of claim 5, wherein the apoenzyme of quinoprotein glucose dehydrogenase is obtained from Acinetobacter Calcoaceticus.

7. The electrochemical test strip of claim 1, wherein the mixture is filtered by passage through a 100 micron sieve bag or a 100 micron filter integral to a pumping system.

8. An electrochemical test strip comprising electrodes;

and

a reagent comprising reaction components appropriate for performing a test and polyethylene oxide having a mean molecular weight from about 100 kilodaltons to about 900 kilodaltons,

wherein the reagent is adapted to redissolve or resuspend upon addition of an aqueous test sample to the reagent.

9. The electrochemical test strip of claim 8, wherein the mean molecular weight of polyethylene oxide is about 300 kilo Daltons.

10. The electrochemical test strip of claim 8, wherein the dried reagent comprises about 6.2% polyethylene oxide by weight.

11. The electrochemical test strip of claim 8, wherein the dried reagent comprises from about 2,000 to about 9,000 units of enzyme activity per gram of reagent.

12. The electrochemical test strip of claim 8, wherein the reaction components appropriate for performing a test include an enzyme quinoprotein glucose dehydrogenase and a redox mediator ferricyanide.

13. The electrochemical test strip of claim 8, wherein a reaction component is selected from the group consisting of enzyme quinoprotein glucose dehydrogenase, polyethylene oxide, microcrystalline hydroxyethylcellulose, microcrystalline cellulose, monobasic potassium phosphate, dibasic potassium phosphate, potassium ferricyanide, sodium succinate, trehalose, and a surfactant.

14. The electrochemical test strip of claim 13, wherein the enzyme quinoprotein glucose dehydrogenase comprises a stabilized association of coenzyme PQQ and the apoenzyme of quinoprotein glucose dehydrogenase.

15. The electrochemical test strip of claim 14, wherein the apoenzyme of quinoprotein glucose dehydrogenase is obtained from Acinetobacter Calcoaceticus.