Device for determination of an analyte a in body fluid

• US 20020052050A1
• Filed: 06/07/2001
• Published: 05/02/2002
• Est. Priority Date: 06/17/1997
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Gleisner, John M., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S., Priest, John H., Hasker, David A.
• Granted Patent: US 6,780,651 B2
• Time in Patent Office: Days
• 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 strip for testing for the presence or concentration of an analyte in a fluid comprising:

a support member;

a spreading layer on the first side of the support member;

a reagent layer on the spreading layer which comprises a reagent selected for the analyte of interest; and

a capillary tube on the opposite side of the support member communicating through an aperture in the support member with the spreading layer, whereby a fluid containing an analyte introduced into the tube flows through the tube and the spreading layer to contact the reagent.

2. A test strip according to claim 1 comprising

a carrier layer on the reagent layer and positioned on the other side of the reagent layer from the spreading layer;

and

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

3. A test strip according to claim 1 comprising a vent opening in the support member communicating with the spreading layer or the reagent layer for the expulsion of air when fluid flows through the tube.

4. A test strip according to claim 2 comprising a vent opening in the carrier layer communicating with the spreading layer or the reagent layer for the expulsion of air when fluid flows through the tube.

5. A test strip according to claim 1 comprising a sensor in the capillary tube for electrical detection of the presence of liquid at a preselected point in the tube.

6. A test strip according to claim 2 comprising barrier members defming a predetermined volume of the spreading layer and reagent layer in communication with the tube.

7. A test strip according to claim 1 wherein the capillary tube is positioned at an angel from about 15°

through 90°

relative to the surface of the support member.

8. A test strip according to claim 1 comprising a filtering layer positioned between the tube and the reagent layer for separating suspended solid materials from the liquid flowing from the tube to the reagent layer.

9. A test strip according to claim 1 wherein the support member contains a recessed area for receiving the spreading layer and reagent layer.

10. A test strip according to claim 2 wherein the support member contains a recessed area for receiving the spreading layer and reagent layer.

12. A method according to claim 9 comprising measuring the indication of the reagent with an electronic meter.

11. A method of testing a fluid for the presence or concentration of an analyte comprising:

providing a test strip comprising;

a support member;

a spreading layer on the first side of the support member;

a reagent layer on the spreading layer which comprises a reagent selected for the analyte of interest; and

a capillary tube on the opposite side of the support member communicating through an aperture in the support member with the spreading layer, whereby a fluid containing an analyte introduced into the tube flows through the tube and the spreading layer to contact the reagent;

introducing sufficient fluid containing an analyte into the capillary tube to flow onto the reagent layer; and

observing or measuring the indication of the reagent.

14. A method of claim 13 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.

15. A method of claim 13 comprising:

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

mounting the preassembled layer on the support member.

16. A method of claim 13 comprising:

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

17. A method of claim 14 comprising:

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

18. A method of claim 15 comprising:

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

13. 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.