Method for manufacturing an enzymatic reagent ink

• US 8,025,788 B2
• Filed: 04/24/2009
• Issued: 09/27/2011
• Est. Priority Date: 04/24/2009
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: O'Connell, Michael, Cardosi, Marco F.
• Primary Examiner(s): Barton; Jeffrey T
• Assistant Examiner(s): BALL, JOHN C
• Application Number:
  US12/429,376
• Publication Number:
  US 20100270151A1
• Time in Patent Office: 886 Days
• Field of Search: 204/403.01, 204/403.14, 204/291, 205/777.5, 422/82.01, 435/14, 435/25, 436/72
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

A method for manufacturing an enzymatic reagent ink for use in analytical test strips (such as electrochemical-based analytical test strips configured for the determination of glucose in blood) includes determining a first relationship between wetability of a representative hydrophobic silica material (e.g., a hydrophobic fumed silica material) and at least a first calibration characteristic (for example, a calibration slope) of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material. In the method, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The method also includes determining a second relationship defining wetability of a mixture of a particular hydrophobic silica material and a particular surfactant across a range of relative amount of the particular hydrophobic silica material and the particular surfactant and, subsequently, combining an amount of the particular hydrophobic silica material, an amount of the particular surfactant, and an amount of enzyme (such as glucose oxidase) to form an enzymatic reagent ink. Moreover, the amounts of the particular hydrophobic silica material and the particular surfactant are predetermined based on the second relationship to provide at least the minimum wetability defined by the first relationship.

Claims

1. A method for manufacturing an enzymatic reagent ink for use in analytical test strips, the method comprising:

determining a first relationship between wetability of a representative hydrophobic silica material and at least a first calibration characteristic of an analytical test strip that includes an enzymatic reagent ink containing the representative hydrophobic silica material, the first relationship defining a minimum wetability that provides a first calibration characteristic of a calibration slope and/or a calibration intercept;

determining a second relationship defining wetability of a mixture of a particular hydrophobic silica material and a particular surfactant across a range of relative amounts of the particular hydrophobic silica material and the particular surfactant; and

combining, at least, relative amounts of the particular hydrophobic silica material and the particular surfactant, and an amount of enzyme to form an enzymatic reagent ink that is devoid of the representative hydrophobic silica material;

wherein the relative amounts of the particular hydrophobic silica material and the particular surfactant in the combining step are predetermined based on the second relationship to provide at least the minimum wetability defined by the first relationship and, therefore, the first calibration characteristic of a calibration slope and/or a calibration intercept; and

wherein the representative hydrophobic silica material and the particular hydrophobic silica materials are non-identical hydrophobic silica materials.

2. The method of claim 1 wherein the representative hydrophobic silica material and the particular hydrophobic silica material are hydrophobic fumed silica materials.

3. The method of claim 1 wherein the particular surfactant is a non-ionic surfactant.

4. The method of claim 3 wherein the non-ionic surfactant is a polyglycol ether aromatic ring containing non-ionic surfactant.

5. The method of claim 1 wherein the at least a first calibration characteristic is a calibration slope.

6. The method of claim 1 wherein the at least a first calibration characteristic is a calibration intercept.

7. The method of claim 1 wherein the wetability is determined as gel height in a methanol and water solution.

8. The method of claim 1 wherein wetability is determined as gel volume in a methanol and water solution.

9. The method of claim 1 wherein the enzymatic reagent ink is a screen printable enzymatic reagent ink.

10. The method of claim 1 wherein the analytical test strip is an electrochemical-based analytical test strip configured for the determination of glucose in a blood sample.

11. The method of claim 1 wherein the enzyme is glucose oxidase.

12. The method of claim 1 wherein the amount of the particular surfactant is such that the particular surfactant is present at a concentration of at least 0.10% v/v when being combined with the amount of particular hydrophobic silica material.