Device for determination of an analyte in a body fluid

• US 6,780,651 B2
• Filed: 06/07/2001
• Issued: 08/24/2004
• Est. Priority Date: 06/17/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Duchon, Brent G., Douglas, Joel S., Radwanski, Ryszard, Priest, John H., Gleisner, John M., Hasker, David A.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/875,297
• Publication Number:
  US 20020052050A1
• Time in Patent Office: 1,174 Days
• Field of Search: 435/4, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/287.9, 435/805, 435/810, 435/970, 422/55-58, 436/164, 436/169, 436/170, 436/518, 436/530, 436/805, 436/810
• US Class Current: 436/518
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Claims

1. A method of making a strip for testing for the presence or concentration of an analyte in a fluid comprising:

providing a support member with a capillary tube positioned on one side of the support member and communicating with the opposite side of the support member through an aperture in the support member;

mounting a spreading layer on the opposite side of the support member and in communication with the aperture in the support member; and

mounting a reagent layer on the spreading layer.

2. A method of claim 1 comprising:

mounting a carrier strip on the reagent layer opposite the spreading layer; and

providing an aperture in the carrier layer for observing or measuring the indication of the reagent.

3. A method of claim 1 comprising:

preassembling the carrier layer, the reagent layer and the spreading layer; and

mounting the preassembled layer on the support member.

4. A method of claim 1 comprising:

providing a support member with a recessed area for receiving the spreading layer and the reagent layer.

5. A method of claim 2 comprising:

providing a support member with a recessed area for receiving the spreading layer and the reagent layer.

6. A method of claim 3 comprising:

providing a support member with a recessed area for receiving the spreading layer and the reagent layer.

9. The method of claim 1, further comprising:

providing the support member with barrier members; and

creating a predetermined volumetric space by deforming the spreading layer into a shape conforming to the barrier members.

7. A method of making a strip for testing for the presence or concentration of an analyte in a fluid comprising:

providing a support member with a capillary;

mounting a spreading layer onto the support member in communication with the capillary; and

mounting a reagent layer on the spreading layer.

8. The method of claim 7, wherein the capillary defines a predetermined volume.

10. A method of claim 7 comprising:

mounting a carrier strip on the reagent layer opposite the spreading layer; and

providing an aperture in the carrier layer for observing or measuring the indication of the reagent.

11. A method of claim 10 comprising:

providing a support member with a recessed area for receiving the spreading layer and the reagent layer.

12. The method of claim 7, further comprising:

providing the support member with barrier members; and

creating a predetermined volumetric space by deforming the spreading layer into a shape conforming to the barrier members.