ANALYTICAL TEST STRIPS

• US 20100273249A1
• Filed: 04/24/2009
• Published: 10/28/2010
• Est. Priority Date: 04/24/2009
• Status: Abandoned Application

• Current Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: CARDOSI, Marco F., O'CONNELL, Michael
• Application Number:
  US12/429,405
• Publication Number:
  US 20100273249A1
• Time in Patent Office: Days
• US Class Current: 435/287.800
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

An analytical test strip includes a substrate and a reagent layer disposed on a portion of the substrate. The reagent layer includes an enzymatic reagent ink comprising an amount of hydrophobic silica material, an amount of surfactant; and an amount of enzyme. The amounts of the hydrophobic silica material and the surfactant in the enzymatic reagent ink is predetermined using a first relationship and a second relationship. The first relationship is 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. In addition, the first relationship defines a minimum wetability that provides an acceptable first calibration characteristic. The second relationship defines wetability of a mixture of the hydrophobic silica material and the surfactant across a range of relative amounts of the hydrophobic silica material and the surfactant. The predetermined amounts of the hydrophobic silica material and the surfactant employed in the enzymatic reagent ink provide at least the minimum wetability defined by the first relationship during manufacturing of the enzymatic reagent ink and, therefore, an acceptable first calibration characteristic.

Claims

1. An analytical test strip comprising:

a substrate; and

a reagent layer disposed on a portion of the substrate, the reagent layer including an enzymatic reagent ink comprising;

an amount of hydrophobic silica material;

an amount of surfactant; and

an amount of enzyme,

wherein the amounts of the hydrophobic silica material and the surfactant in the enzymatic reagent ink is predetermined using;

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 an acceptable first calibration characteristic; and

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

such that the amounts of the hydrophobic silica material and the surfactant provide at least the minimum wetability defined by the first relationship during manufacturing of the enzymatic reagent ink.

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

3. The analytical test strip of claim 1 wherein the particular surfactant is a non-ionic surfactant.

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

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

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

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

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

9. The analytical test strip of claim 1 wherein the enzymatic reagent ink is a screen printable enzymatic reagent ink with a viscosity in the range of 36,000 to 48,000 cP.

10. The analytical test strip 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 analytical test strip of claim 1 wherein the enzyme is glucose oxidase.

12. The analytical test strip of claim 1 wherein the amount of surfactant is such that the surfactant is present at a concentration of at least 0.10% v/v during manufacturing of the enzymatic reagent ink and at a concentration of at least 0.07% by mass in the enzymatic reagent ink.