Electrochemical biosensor test strip

• US 5,762,770 A
• Filed: 06/30/1995
• Issued: 06/09/1998
• Est. Priority Date: 02/21/1994
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation (Roche Holding AG)
• Inventors: Pritchard, G. John, Hubbard, Scott E., Bateson, Joseph E., Hill, Brian S., Heald, Brian A.
• Primary Examiner(s): Tung, T.
• Application Number:
  US08/496,939
• Time in Patent Office: 1,075 Days
• Field of Search: 204/403, 204/416, 204/418, 204/419, 435/817, 435/4, 435/11, 435/14, 435/288, 435/291, 205/777.5
• US Class Current: 204/403.14
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

An electrochemical biosensor test strip that has a minimum volume blood sample requirement of about 9 microliters. The test strip has working and counter electrodes that are substantially the same size and made of the same electrically conducting material placed on a first insulating substrate. Overlaying the electrodes is a second insulating substrate, which includes a cutout portion that forms a reagent well. The cutout portion exposes a smaller area of the counter electrode than the working electrode. A reagent for analysis of an analyte substantially covers the exposed areas of working and counter electrodes in the reagent well. Overlaying the reagent well and affixed to the second insulating substrate is a spreading mesh that is impregnated with a surfactant. The small cutout portion of 4 millimeters by 4.2 millimeters, small mesh of 6 millimeters by 5.8 millimeters, and small amount of reagent, 4 microliters before drying, allow the test strip to analyze a whole blood sample of about 9 microliters.

Claims

1. A device for detecting or measuring the concentration of an analyte, comprising:

a first electrical insulator;

two electrodes only said electrodes consisting of a working electrode and a counter electrode of substantially the same size, made of the same electrically conducting materials and supported on the first electrical insulator;

a second electrical insulator, overlaying the first electrical insulator and the electrodes and including a cutout portion that exposes a smaller surface area of the counter electrode than the working electrode;

a reagent for detecting or measuring the concentration of the analyte, the reagent substantially covering the exposed electrode surfaces in the cutout portion; and

a spreading mesh, impregnated with a surfactant, overlaying the cutout portion and affixed to the second electrical insulator,

wherein the cutout portion and spreading mesh are of sufficient size and the reagent is in sufficient amount to receive a minimum whole blood sample of about 9 microliters for analyzing the analyte.

2. The device of claim 1, wherein the spreading mesh is affixed to the second substrate by tape having an adhesive on one side and a hole that exposes at least a portion of the spreading mesh and the cutout portion, and wherein the tape also includes at least one slit near the hole, thereby providing at least one air vent.

3. The device of claim 2, wherein the tape includes slits on opposing sides of the hole, thereby providing two air vents.

4. The device of claim 2, wherein the cutout portion is 4 millimeters by 4.2 millimeters.

5. The device of claim 4, wherein the spreading mesh is 6 millimeters by 5.8 millimeters.

6. The device of claim 5, wherein the amount of reagent is 4 microliters before drying.

7. The device of claim 6, wherein the spreading mesh is impregnated with dioctylsodium sulfosuccinate.

8. The device of claim 7, wherein the hole in the tape exposes substantially all of the cutout portion.

9. The device of claim 8, further comprising a current measuring meter in electrical connection with the working and counter electrodes.

10. The device of claim 1, further comprising a current measuring meter in electrical connection with the working and counter electrodes.