Biosensor with predetermined dose response curve and method of manufacturing

• US 8,608,937 B2
• Filed: 03/30/2009
• Issued: 12/17/2013
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Groll, Henning
• Primary Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US12/413,778
• Publication Number:
  US 20100243441A1
• Time in Patent Office: 1,723 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 435 4- 4052
• US Class Current: 205/777.5
• CPC Class Codes: B29C 65/74 by welding and severing , or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
• 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 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention provides a system of biosensors whose dose-response curves are maintained within a predetermined and desired range or tolerance during production by selecting a feature of the biosensors that can be varied during production. For example, in one exemplary embodiment the effective area of the working electrode of an electrochemical biosensor can be varied during production as needed to offset variations that occur, e.g., in the reagent of the biosensors as production proceeds. In another exemplary embodiment, the dose-response curve of biosensors not yet produced can be predicted and one or more features of these biosensors can be selected to maintain the dose-response curve within a predetermined range or tolerance.

Claims

1. A method of manufacturing electrochemical biosensors of the same model, comprising:

(a) producing a first biosensor having a first electrical pattern with a first effective area;

(b) determining a dose-response curve of the first biosensor;

(c) using the dose-response curve determined for the first biosensor to predict a second effective area for a second electrical pattern of a second biosensor before the second biosensor is made, the second effective area being different from the first effective area; and

(d) forming the second biosensor, the second effective area being obtained during initial formation of the second electrical pattern, wherein the second biosensor has a dose-response curve that is within a desired predetermined range.

2. The method of claim 1, wherein step (a) comprises forming a first working electrode of the first biosensor with a first width and step (d) comprises forming a second working electrode of the second biosensor with a second width that is different from the first width.

3. The method of claim 2, wherein step (a) comprises forming the first working electrode and a first counter electrode with a gap therebetween and step (d) comprises maintaining the same size of the gap in the second biosensor.

4. The method of claim 2, wherein step (a) comprises forming the first working electrode and a first counter electrode with a first gap therebetween and step (d) comprises forming the second working electrode and a second counter electrode with a second gap therebetween, the second gap having a different size than the first gap.

5. The method of claim 1, wherein:

the first biosensor comprises a plurality of first biosensors;

the dose-response curve determined in step (b) comprises an average dose-response curve of the plurality of first biosensors; and

the second biosensor comprises a plurality of second biosensors.

6. The method of claim 5, further comprising:

determining an average dose-response curve of the plurality of second biosensors;

predicting a third effective area for a third electrical pattern for a plurality of third biosensors before the third biosensors are made, the third effective area being different from the second effective area; and

forming the plurality of third biosensors with the third electrical patterns having the third effective area, wherein the plurality of third biosensors has a dose-response curve that is within the desired predetermined range.

7. The method of claim 6, wherein the first and third effective areas are the same.

8. The method of claim 5, wherein the plurality of first biosensors comprises a first production lot of biosensors and the plurality of second biosensors comprises a second production lot of biosensors.

9. The method of claim 5, further comprising establishing upper and lower control limits which define the desired predetermined range.