Device for determination of an analyte in a body fluid

• US 5,948,695 A
• Filed: 06/17/1997
• Issued: 09/07/1999
• Est. Priority Date: 06/17/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S., Priest, John H., Gleisner, John M., Hasker, David A.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/874,468
• Time in Patent Office: 812 Days
• Field of Search: 422/55-58, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/287.9, 435/805, 435/810, 435/970, 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 strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

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 a 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 attached to a side of the support member opposite from said first side 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 a side of the reagent layer opposite from the spreading layer;

and

an aperture in the carrier layer for observing or measuring an indication of the reagent to determine the presence or concentration of the analyte.

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 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 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 defining 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 angle 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 a 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 attached to a side of the support member opposite said first side 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 the analyte into the capillary tube to flow onto the reagent layer; and

observing or measuring an indication of the reagent to determine the presence or concentration of the analyte.