Analyte measurement device and method of use

• US 6,924,093 B2
• Filed: 01/30/2003
• Issued: 08/02/2005
• Est. Priority Date: 06/19/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Bennett, Gregory, Bird, Dennis, Hufford, William, Haviland, Alan
• Primary Examiner(s): Gitomer, Ralph
• Application Number:
  US10/354,561
• Publication Number:
  US 20030113927A1
• Time in Patent Office: 915 Days
• Field of Search: 435/4, 435/287.7, 435/970, 435/58, 435/56, 435/57, 435/63, 422 56- 58, 422/63, 436/169
• US Class Current: 435/4
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Devices, systems, methods and kits are provided for use in determining the concentration of chemical and biochemical components in aqueous fluids. The subject devices include test strips which define a longitudinal axis and include a distal edge configured for insertion into a measurement instrument and having an alignment notch formed in the distal edge for engagement with an alignment member of the measurement instrument. The alignment notch has opposing edges wherein at least a portion of the opposing edges is in substantially parallel relation to the longitudinal axis. In using the subject devices, the devices are inserted into a measurement instrument having an alignment pin. When operatively engaged with the alignment pin, the notch serves to maintain the device in a substantially motionless position. The invention is useful in a variety of applications, particularly in the determination of blood glucose concentrations.

Claims

1. A test strip for insertion into a measurement instrument having an alignment member therein for engagement with said test strip, said test strip comprising:

(a) a longitudinal axis;

(b) a distal edge substantially transverse to said longitudinal axis and configured for insertion into said measurement instrument;

(c) an alignment notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and

(d) a non-circular aperture for receiving a volume of sample therein, the non-circular aperture having a major axial dimension that is coaxial with the longitudinal axis.

2. The test strip of claim 1 wherein the non-circular aperture is adapted for receiving a volume of sample that is less than about 35 μ

L.

3. The test strip device of claim 2 wherein said volume of sample is less than about 10 μ

L.

4. The test strip device of claim 3 wherein the volume of sample is less than about 5 μ

L.

5. The test strip device of claim 1 wherein said non-circular aperture has an obround configuration.

6. The test strip of claim 2 wherein said aperture has a surface area no greater than about 15 mm².

7. The test strip of claim 2 further comprising a support member and a sample-absorbing member, wherein said longitudinal axis, said distal edge, said notch and said aperture are features of said support member, said support member further comprising a top surface and a bottom surface wherein said aperture extends from said top surface to said bottom surface, and wherein said sample-absorbing member is fixed to said top or bottom surface of said support member and covers said aperture.

8. The test strip of claim 7 wherein said sample-absorbing member comprises a hydrophilic material.

9. The test strip of claim 8 wherein said hydrophilic material is porous.

10. The test strip of claim 8 wherein said sample-absorbing member comprises at least one reagent material selected for reacting with at least one constituent of said volume of fluid sample.

11. The test strip of claim 10 wherein said fluid sample is blood and said constituent is glucose.

12. A test strip for use in conjunction with a measurement instrument having an alignment member therein and for measuring the concentration of at least-one analyte within a sample of biological fluid, said test strip comprising:

(a) a support member defining a longitudinal axis and comprising;

(i) a distal edge substantially transverse to said longitudinal axis and configured for insertion into said measurement instrument;

(ii) an alignment notch formed in said distal edge for engagement with said alignment member and comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and

(iii) a non-circular aperture therein for receiving said sample of biological fluid;

the non-circular aperture having a major axial dimension that is coaxial with the longitudinal axis and

(b) a reagent pad fixed to said support member and covering said non-circular aperture, said reagent pad containing at least one reagent material selected for reacting with said at least one analyte.

13. The test strip of claim 12 wherein at least a portion of said opposing edges is in angular relation to said longitudinal axis.

14. The test strip of claim 13 wherein said opposing edges comprises at least three portions wherein two of the three portions of said opposing edges are in angular relation to said longitudinal axis.

15. The test strip of claim 13 wherein said portion of said opposing edges in substantially parallel relation is located in between said two portions of said opposing edges in angular relation to said longitudinal axis.