Analyte measurement kit

• US 6,994,825 B2
• Filed: 04/23/2003
• Issued: 02/07/2006
• 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 J
• Application Number:
  US10/422,127
• Publication Number:
  US 20030180825A1
• Time in Patent Office: 1,021 Days
• Field of Search: 435/4, 435/287.7, 435/970, 435/975, 422 56- 58
• US Class Current: 422/404
• 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 kit for measuring the concentration of at least one constituent in a fluid sample by employing a measurement instrument having an alignment member therein, said kit comprising at least one test strip with:

a longitudinal axis;

a distal edge substantially transverse to said longitudinal axis;

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

a non-circular aperture formed therein for receiving said fluid sample, the non-circular aperture having a major axial dimension that is co-axial with the longitudinal axis;

the kit further comprising means for drawing the fluid sample from a patient.

2. The kit according to claim 1 wherein said non-circular aperture has a substantially obround configuration.

3. The kit according to claim 1 further comprising a fluid sample-absorbing member affixed to said at least one test strip and covering said non-circular aperture.

4. The kit according to claim 1 further comprising instructions for using said kit, wherein said instructions instruct a user to apply from less than about 5 to about 35 μ

L of fluid sample to said non-circular aperture.

5. The kit according to claim 4 wherein said instructions of using instruct a user of said kit to apply from less than about 5 to about 10 μ

L of fluid sample to said non-circular aperture.

6. The kit according to claim 5 wherein said instructions of using instruct a user of said kit to apply less than about 5 μ

L of fluid sample to said non-circular aperture.