Device for determination of an analyte in a body fluid using small sample sizes

• US 6,544,474 B2
• Filed: 01/05/2001
• Issued: 04/08/2003
• Est. Priority Date: 09/30/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Douglas, Joel S.
• Primary Examiner(s): Brusca, John S.
• Assistant Examiner(s): Moran, Marjorie A.
• Application Number:
  US09/755,362
• Publication Number:
  US 20010001034A1
• Time in Patent Office: 823 Days
• Field of Search: 435/7.1, 435/287.1, 435/287.6, 435/287.7, 435/287.8, 435/288.1, 435/288.7, 435/287.9, 436/169, 422/56, 422/58, 422/82.05, 422/57, 356/929
• US Class Current: 422/404
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0838 Capillaries
• 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: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

Devices and methods for utilizing dry chemistry dye indicator systems for body fluid analysis such as glucose level in whole blood are provided by incorporating an indicator in a bibulous matrix contained inside a hollow fiber capillary tube adapted to wick the fluid sample into the tube to wet the matrix and indicator system. The devices also enable visual or meter reading of the indicator by positioning the hollow fiber capillary tube in a housing having an optical opening adapted for receiving light form a source and directing the light to the capillary tube and for directing the light reflected therefrom to a detector. An advantage for the individual user is the small fluid, e.g., blood sample required, which enables the user to avoid using finger tip sticks for samples. Another aspect of the device provides a determination of and correction for hematocrit level in whole blood in combination with indicator indication of analyte concentration. The devices provided are low cost due to efficient manufacturing.

Claims

1. A device for testing a body fluid for concentration of an analyte, said device comprising:

a hollow fiber capillary tube, said hollow fiber capillary tube comprising a tube wall defining a hollow core, said tube wall comprising a matrix for receiving a fluid sample;

an indicating reagent contained in said matrix for reacting with an analyte to provide indication of the concentration of the analyte; and

a housing in which the hollow fiber capillary tube is positioned, said housing having an opening adapted for receiving light from a light source and for directing light reflected from the hollow fiber capillary tube to a light detector.

2. A device according to claim 1 wherein the capillary tube inside diameter is between 0.001 inches and 0.100 inches.

3. A device according to claim 1 wherein the capillary tube is formed from a hydrophilic polymer or a hydrophobic polymer coated or treated with a hydrophilic surface treating agent.

4. A device according to claim 3 wherein the polymer comprises polyethersulphone, polysulphone, polyyrethane, nylon, nitrocellulose, polyethylene, polytetrafluoroethylene, halogenated vinyl polymers or cellulose derivatives.

5. A device according to claim 1 wherein the housing opening comprises an optical cavity adapted to optimize the alignment of the hollow fiber capillary tube with the light source and detector.

6. A device according to claim 1 in combination with a meter comprising a light source and a light detector positioned to provide light to and receive reflected light from the hollow fiber capillary tube positioned in the opening of the housing.

7. A method for determining the concentration of an analyte in a body fluid, said method comprising:

(a) providing a device comprising;

a hollow fiber capillary tube, said hollow fiber capillary tube comprising a tube wall defining a hollow core, said tube wall comprising a matrix for receiving a fluid sample;

an indicating reagent contained in the matrix for reacting with the analyte to provide indication of the concentration of the analyte; and

a housing in which the hollow fiber capillary tube is positioned, said housing having an opening adapted for receiving light from a light source and for directing light reflected from the hollow fiber capillary tube to a light detector;

(b) contacting the hollow fiber capillary tube with a sample of body fluid to allow the sample to wick into the tube thereby wetting the matrix and indicator; and

(c) measuring a color change of the indicator and determining the concentration of the analyte in the sample.