Device for determination of an analyte in a body fluid

• US 6,271,045 B1
• Filed: 05/07/1999
• Issued: 08/07/2001
• Est. Priority Date: 06/17/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• 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:
  US09/306,994
• Time in Patent Office: 823 Days
• Field of Search: 422/55-58, 435/287.1, 435/287.2, 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 test strip for testing for the presence or concentration of an analyte in a sample of body fluid, the strip comprising:

a test area;

a first member comprising a capillary defining a predetermined volume, the first member constructed to produce a capillary action which is sufficient to draw a sample of body fluid having a volume corresponding to the predetermined volume of the capillary into the test strip and deliver the sample to the test area; and

a second layer attached to the first member.

2. The strip of claim 1, wherein the capillary is hydrophillic.

3. The strip of claim 1, wherein the predetermined volume is 1-5 microliters.

4. A method of collecting and transporting a fluid sample, the method comprising the steps of:

(i) providing a test strip comprising;

a test area;

a first member comprising a capillary defining a predetermined volume; and

a second layer attached to the first member;

(ii) introducing the sample into the test strip via the capillary;

(iii) filling the predetermined volume of the capillary with the sample; and

(iv) transporting the sample to the test area.

5. The method of claim 4, wherein step (i) further comprises providing the capillary with hydrophillic properties.

6. The method of claim 4, wherein step (i) further comprises providing the capillary with a predetermined volume of 1-5 microliters.