METHOD FOR DETERMINING AN ANALTYE IN A BODILY FLUID

• US 20090317847A1
• Filed: 06/24/2008
• Published: 12/24/2009
• Est. Priority Date: 06/24/2008
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Tannenbaum, Susan, Davis, John Christopher, Leong, Koon-Wah, Perasso, Herb, Jones, Janice, Chu, Caroline, Mahoney, John
• Granted Patent: US 8,178,313 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

A method for determining (e.g., detecting and/or measuring the concentration of) an analyte in a bodily fluid sample includes obtaining a bodily fluid sample, applying the bodily fluid sample to an analyte test strip, transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip, and determining an analyte in the bodily fluid sample. The analyte test strip employed in the method includes a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip. Moreover, the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port. The analyte test strip also includes a second port in fluidic communication with the sample-receiving chamber and an outer edge of the analyte test strip, the second port configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and for transferring at least a portion of the second bodily fluid sample to sample-receiving chamber. In addition, the applying step involves applying the bodily fluid sample to one of the second port and the platform portion of the analyte test strip depending on the volume of the bodily fluid sample.

Claims

1. A method for determining an analyte in a bodily fluid sample, the method comprising:

obtaining a bodily fluid sample;

applying the bodily fluid sample to an analyte test strip;

transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip; and

determining an analyte in the bodily fluid sample,

wherein the analyte test strip includes;

a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip, the platform portion configured to receive a first bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port; and

a second port in fluidic communication with the sample-receiving chamber and an outer edge of the analyte test strip, the second port configured to receive a second bodily fluid sample of lesser volume than the first bodily fluid sample and for transferring at least a portion of the second bodily fluid sample to sample-receiving chamber,

wherein the applying step involves applying the bodily fluid sample to one of the second port and the platform portion of the analyte test strip depending on the volume of the bodily fluid sample.

2. The method of claim 1 wherein the bodily fluid sample is a whole blood sample and the analyte is glucose.

3. The method of claim 1 wherein the platform portion is configured to receive a bodily fluid sample of at least 25 microliters and the second port is configured to receive a bodily fluid sample of less than 5 microliters.

4. The method of claim 1 wherein the obtaining step includes obtaining a bodily fluid sample with one of a syringe, pipette and hypodermic needle.

5. The method of claim 1 wherein the obtaining step includes obtaining a bodily fluid sample by expressing the bodily fluid sample from a user'"'"'s finger.

6. The method of claim 1 wherein the applying step is aided by visual guidance of a notch in the platform portion.

7. The method of claim 1 wherein the second port is on a lateral edge of the analyte test strip.

8. The method of claim 1 wherein the second port is on a proximal end edge of the analyte test strip.

9. The method of claim 1 wherein a user manipulates the analyte test strip by a handle of the analyte test strip during the applying and determining steps.

10. The method of claim 1 wherein the determining step employs a first electrode and a second electrode of the analyte test strip to conduct an electrochemical-based determination of the analyte.