Test strips having reaction zones and channels defined by a thermally transferred hydrophobic barrier

• US 6,723,500 B2
• Filed: 12/05/2001
• Issued: 04/20/2004
• Est. Priority Date: 12/05/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Yu, Yeung Siu
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US10/011,000
• Publication Number:
  US 20030104510A1
• Time in Patent Office: 867 Days
• Field of Search: 435/4, 435/14, 435/25, 435/287.8, 435/805, 435/970, 435/973, 422/55-60, 422/947, 436/169, 436/170
• US Class Current: 435/4
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

Test strips, and methods for their manufacture and use in the determination of the concentration of at least one analyte in a physiological sample are provided. The subject test strips have a plurality of reaction zones defined by a hydrophobic barrier. The reagent compositions present in each reaction zone may be the same or different. In addition, each reaction zone may have a separate fluid channel, or two or more of the reaction zones may have separate channels that merge into a single channel. In use, sample is applied to a subject test strip, a signal is detected and then related to the amount of analyte in the sample. Also provided are methods for manufacturing the subject test strips using thermal transfer technology to apply the hydrophobic barrier. Finally, kits are provided for use in practicing the subject methods.

Claims

1. A test strip for determining a concentration of at least one analyte in a physiological sample, said test strip comprising:

a porous matrix;

a plurality of reaction zones, wherein each of said reaction zones is defined in the porous matrix by a hydrophobic barrier deposited using thermal transfer technology;

at least one fluid channel for delivering the physiological sample to at least one of the plurality of reaction zones, the at least one fluid channel defined by the hydrophobic barrier; and

a reagent composition present in each of said reaction zones.

2. The test strip of claim 1, wherein said hydrophobic barrier comprises hydrophobic ink.

3. The test strip of claim 1, wherein each of said reaction zones comprise the same reagent composition.

4. The test strip of claim 1, wherein at least two of said reaction zones comprise different reagent compositions.

5. The test strip of claim 1, wherein at least two of said reaction zones are adapted for assaying for the same analyte, wherein said at least two of said reaction zones comprise different concentrations of at least one component of a testing reagent composition.

6. The test strip of claim 1, wherein at least one of said reagent compositions comprises at least one member of an analyte oxidation based signal producing system.

7. The test strip of claim 6, wherein said signal producing system further comprises an enzyme that converts at least one substrate into a chromogenic product in the presence of hydrogen peroxide.

8. The test strip of claim 7, wherein said at least one substrate comprises a dye couple.

9. The test strip of claim 7, wherein said enzyme is an oxidizing enzyme.

10. The test strip of claim 9, wherein said oxidizing enzyme is a glucose oxidizing enzyme.

11. The test strip of claim 1, wherein said analyte is glucose.

12. The test strip of claim 1, wherein said test strip is present in a meter.

13. The test strip of claim 1, wherein each of said reaction zones has its own fluid channel to provide for fluid communication between said reaction zone and the an external environment.

14. The test strip of claim 1, wherein at least two of said reaction zones have fluid channels that merge to produce a single channel to provide for fluid communication between said reaction zones and an external environment of said test strip.