Analyte measurement device and method of use

• US 6,576,416 B2
• Filed: 06/19/2001
• Issued: 06/10/2003
• 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:
  US09/884,368
• Publication Number:
  US 20020192807A1
• Time in Patent Office: 721 Days
• Field of Search: 435/4, 435/287.7, 435/970, 422/56-58, 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 method of measuring the concentration of at least one constituent in a fluid sample, the method comprising the steps of:

(a) providing a test device defining a longitudinal axis and comprising;

(i) a distal edge substantially transverse to said longitudinal axis;

(ii) an alignment notch formed in said distal edge for engagement with an alignment pin of a measurement instrument adapted for measuring the concentration of said at least one constituent in said fluid sample, said alignment notch comprising opposing edges wherein at least a portion of said opposing edges is in substantially parallel relation to said longitudinal axis; and

(iii) an aperture formed therein for receiving said fluid sample, said aperture having an obround aperture shape with a major axial length that is coaxial with said longitudinal axis;

(b) inserting said test device into said measurement instrument; and

(c) operatively engaging said alignment notch with said alignment pin.

2. The method of claim 1 further comprising the step of maintaining said test device in a substantially motionless position while said test strip is operatively engaged with said alignment pin.

3. The method of claim 1 wherein an apex-to-apex distance between said alignment notch and said aperture of the test strip is adapted to minimize the effect of any proximal displacement experienced by said test strip upon insertion into said measurement instrument.

4. The method of claim 1 further comprising the step of applying from about 5 μ

L to 35 μ

L of said fluid sample to said aperture.